[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-sclerosing-cholangitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-sclerosing-cholangitis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,42,70,98,121,146,175,201,225,247,266,293,314,345,378,407,430,460,482,506,527,544,568,591],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100622740","phase-3-a-study-to-assess-how-well-and-safely-elafibranor-works-in-adult-participants-with-primary-sclerosing-cholangitis-100622740",false,"NCT07387549","A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis","A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis","ELASCOPE","Inclusion Criteria:\n\n* Adults participants aged 18 years or older\n* Confirmed diagnosis of primary sclerosing cholangitis based on standard clinical, biochemical, and imaging criteria\n* Compensated liver disease at screening\n* Stable background therapy, where applicable prior to study entry\n* Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control\n* Ability to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n\\- History or presence of other concomitant chronic liver disease\n\n\\- History of hepatic decompensation, including: i) History of liver transplantation, current MELD 3.0 score ≥12 due to hepatic impairment.\n\nii) Evidence of complications of cirrhosis\n\n* Participants with cirrhosis who are also classified as Child-Pugh B or C based on the Child Pugh score.\n* History of biliary intervention within 60 days prior to the screening period, and\u002For presence of percutaneous drain or bile duct stent at SV.\n* History of bacterial cholangitis, and\u002For participant on antibiotics for prophylaxis of recurrent cholangitis within 60 days prior to the SV.\n* History or any current suspicion of cholangiocarcinoma or hepatocellular carcinoma\n* Known malignancy or history of malignancy within the last 5 years, with the exception of local, successfully treated basal cell carcinoma or in-situ carcinoma of the uterine cervix.\n* Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).\n* Administration of the following medications are prohibited as specified below:\n\n  i) 3 months prior to baseline: norucholic acid, fibrates, seladelpar and glitazones.\n\nii) 3 months prior to baseline: cyclosporine, mycophenolate, pentoxifylline, and chronic systemic corticosteroids (except as part of management of IBD at an ongoing stable dose); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin).\n\n* Participants who are currently participating in, plan to participate in, or have participated in an investigational drug or medical device study containing active substance within 30 days or five half-lives, whichever is longer, prior to the SV. - Participants with previous exposure to elafibranor.\n* Electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) \\>450 msec in males or QTcF \\>470 msec in females for participants without bundle branch block.\n* Significant renal disease,\n* For female participants: known pregnancy, or has a positive serum pregnancy test, or lactating.\n* Regular alcohol intake in excess of the recommended limit of 2 standard drinks per day for men or 1 standard drink per day for women\n* History of alcohol abuse, or other substance abuse within 1 year prior to SV.\n* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that contraindicates participation in the study.\n* Mental instability or incompetence\n* Participant has or is known to have tested positive for human immunodeficiency virus (HIV) type 1 or 2 at SV.\n* Medical conditions that may diminish life expectancy to \\\u003C2 years.","ALL","18 Years","75 Years",{"count":21,"type":22},350,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this study is to find out how well and safely elafibranor works compared to placebo in adult participants with Primary sclerosing cholangitis (PSC). PSC is a rare disease that causes inflammation and scarring of the bile ducts in the liver. Over time, this can lead to liver damage and serious health problems, including the need for a liver transplant and death.\n\nIn this study, about 350 participants with large duct PSC will take part. Participants will be randomized to receive either elafibranor 120 mg once daily or a placebo (a tablet with no active medicine). The study includes a screening period, an treatment period, and a post-treatment safety follow-up.\n\nDuring the study, participants will undergo routine clinical assessments, laboratory testing, imaging evaluations, and complete patient-reassessments to evaluate liver disease progression, symptoms, quality of life and safety.\n\nFollowing the end of treatment, participants will complete a safety follow-up period at approximately four weeks. Participants may withdraw from the study at any time. Each participant may be in the study for several years, as the treatment period will continue until the study reaches enough health events among participants, which is expected to take about 5 years.",[28],"Primary Sclerosing Cholangitis","RECRUITING","2026-07-01",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":33},"2026-05-14",{"date":37,"type":22},"2031-05-31",{"name":39,"class":40},"Ipsen","INDUSTRY",4,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100415097","unraveling-the-mechanisms-underlying-primary-sclerosing-cholangitis-through-a-multidisciplinary-integrative-research-approach-100415097","NCT04685200","Unraveling the Mechanisms Underlying Primary Sclerosing Cholangitis Through a Multidisciplinary, Integrative Research Approach","* PSC SUBJECTS:\n\nINCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Stated willingness to comply with all study procedures and availability for the duration of the study\n2. Male or nonpregnant female, greater than or equal to 18 years of age\n3. Evidence of PSC established by biochemical testing and either MRCP or ERCP. Participant must have evidence of large duct disease on imaging.\n4. Agreement to adhere to Lifestyle Considerations throughout study duration.\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Pregnant or lactating women or females of child-bearing age not taking measures to prevent pregnancy during the period of study.\n2. History of clinical, serologic, or histopathologic evidence supporting etiologies of chronic liver disease other than PSC\n3. History of liver transplantation\n4. Diagnosis consistent with secondary sclerosing cholangitis (cholelithiasis, bile duct strictures secondary to ischemia, HIV cholangiopathy, etc.).\n5. Current or past clinical evidence of decompensated liver disease (e.g. ascites, bleeding esophageal varices, spontaneous bacterial peritonitis, encephalopathy, etc.).\n6. History of liver or bile duct lesions concerning for malignancy.\n7. Ca-19-9 \\>130 U\u002FmicroL\n8. Alpha-fetoprotein level greater than 200 ng\u002FmicroL.\n9. Patients with active bacterial, viral, or fungal, systemic or localized infection.\n10. Unwillingness to refrain from ingesting probiotics during study.\n11. History of systemic disease not related to PSC that is poorly controlled or associated with declining functional status. Examples include but are not limited to: poorly controlled diabetes mellitus, chronic renal failure with eGFR is \\\u003C60 microl\u002Fmin\u002F1.73m\\^2, chronic\n\n    symptomatic heart failure or severe COPD.\n12. Patients with history of any gastrointestinal malignancy in the last 3 years prior to enrollment will be excluded. Patients with history of any malignancy in the last 3 years prior to enrollment other than those individuals who had undergone curative surgical therapy and deemed as low risk for recurrence by her\u002Fhis treating physician would be excluded.\n13. History of portal vein thrombosis\n14. Patients with severe allergic reactions to iodine or other contrast, which cannot be controlled by premedication with antihistamines or steroids.\n15. History of gastric and\u002For proximal small bowel surgery including bariatric surgery such as Roux-en-Y gastric bypass\n16. Contraindication to monitored anesthesia care and\u002For medications that are commonly used for conscious sedation during GI Endoscopy\n17. Use of anti-coagulant and anti-platelet agents excluding aspirin and NSAIDs\n18. Contraindications to completing MRCP or MRI\n19. Absolute neutrophil count below 1000\u002Fmm\\^3\n20. Hemoglobin level below 10.0 g\u002Fdl\n21. Platelet count lower than 50,000\u002Fmm\\^3.\n22. INR greater than or equal to 1.5, PTT greater thna or equal to 1.3 times control and\u002For any known history of disease associated with\n\n    increased bleeding diathesis.\n23. Inability to provide informed consent\n\nCONTROLS:\n\nINCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Male or female greater than or equal to 18 years of age\n2. Any individual who is either a parent, sibling or child of a PSC patient enrolled to the study, or an unrelated person who has been living with the patient for at least 3 consecutive months before study enrollment\n\nEXCLUSION CRITERIA:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. History suggestive of PSC\n2. History of chronic liver disease (except for steatosis)\n3. Patients with history of any malignancy in the 3 years prior to enrollment other than those individuals who had undergone curative surgical therapy and deemed as low risk for recurrence by her\u002Fhis treating physician would be excluded.\n4. History of Inflammatory Bowel Disease\n5. Antibiotic use within the last 6 weeks\n6. Pregnancy\n7. Inability to provide informed consent",true,"90 Years",{"count":51,"type":22},143,"OBSERVATIONAL","Background:\n\nPrimary sclerosing cholangitis is a rare chronic liver disease. It affects the bile ducts of the\n\nliver. It can result in bile duct infections, cirrhosis, cancer, and end stage liver disease. Researchers want to learn more about this disease.\n\nObjective:\n\nTo understand the biological causes of primary sclerosing cholangitis.\n\nEligibility:\n\nAdults age 18 and older who have primary sclerosing cholangitis.\n\nDesign:\n\nParticipants will be screened with a medical history, physical exam, and blood tests.\n\nParticipants will give blood, saliva, urine, and stool samples. They will have nasal swabs. They will complete surveys.\n\nParticipants will get an intravenous (IV) catheter. A plastic tube is inserted into an arm vein.\n\nParticipants will have a colonoscopy. A tube with a video camera at the end is inserted into the rectum.\n\nParticipants will have an upper endoscopy. A scope with a light and camera at its tip is used to look inside the upper digestive tract.\n\nParticipants will have a liver biopsy, entering through the chest wall or a neck vein. Blood is drawn from a blood vessel that carries blood to the liver. A liver tissue sample is taken.\n\nParticipants will have magnetic resonance imaging or spectroscopy. They will get a contrast agent through an IV.\n\nParticipants may have an optional bone marrow aspiration. A large needle is inserted into the hip to withdraw marrow.\n\nParticipants will have a liver ultrasound.\n\nParticipants will complete a 3-day food diary. They will have a nutrition assessment.\n\nParticipants may give contact details for people who live with them, to also take part in this study.\n\nParticipation will last for 12 months.",[28],[56,57,58],"Inflammatory Bowel Disease","Liver Disease","Natural History","2026-06-12",{"date":61,"type":33},"2026-06-15",{"date":63,"type":33},"2023-03-31",{"date":65,"type":22},"2026-10-31",{"name":67,"class":68},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":97},"100376409","primary-sclerosing-cholangitis-in-children-100376409","NCT04181138","Primary Sclerosing Cholangitis in Children","Prospective Observational Study of Primary Sclerosing Cholangitis (PSC) in Children","Inclusion Criteria:\n\nPatients with the clinical diagnosis of large or small duct PSC made at any time prior to enrollment are screened for eligibility to participate in this prospective cohort study. The site PI will determine eligibility following review of MRCP or ERCP images with the site radiologist to confirm presence of an abnormal cholangiogram at the time of diagnosis of large duct PSC. Liver histopathology obtained at the time of diagnosis of small duct PSC will be reviewed with the site pathologist prior to enrollment.\n\nIndividuals must meet all of the Inclusion criteria in order to be eligible to participate in the study:\n\n1. Aged 2 through 25 years at time of screening.\n2. Diagnosis of large duct PSC based on review of cholangiogram by MRC, ERC, or intraoperative cholangiogram (IOC) by the site radiologist and interpreted to be consistent with PSC, based on one or more of the following:\n\n   * Focal structuring of the bile duct(s)\n   * Dominant stricture of the common bile duct\n   * Saccular dilatation of bile duct(s)\n   * Beaded appearance of bile duct(s)\n   * Pruning appearance of the distal bile duct branches\n\n   AND\u002FOR\n3. Diagnosis of small duct PSC based on review of liver histopathology by the site pathologist and interpreted to be compatible with PSC:\n\n   * Probable small duct PSC: biopsy with ≥3 of 5 criteria: periductal edema, concentric inflammation, bile duct injury, ductular reaction, and neutrophils in bile ducts (cholangitis) OR...\n   * Definitive small duct PSC: Periductal fibrosis\u002F \"onion skinning\" around interlobular bile ducts or smaller profiles\n4. Stated willingness to comply with all study procedures and availability for the duration of the study.\n5. Able to provide informed consent\u002Fassent\n\nParticipants for the imaging study are eligible if they are:\n\n1. Aged 8 through 25 years at the time of screening\n2. No absolute contraindication to MRI\n3. No skin condition that could be aggravated by MREL\n4. Meet all other eligibility criteria of the PSC Observational Study\n5. For whom none of the exclusion criteria apply\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria at baseline will be excluded from participation in this study.\n\n1. History of liver transplantation\n2. History bone marrow transplantation\n3. History of primary or acquired immunodeficiency predisposing to secondary sclerosing cholangitis, for instance: hyper-IgM syndrome, severe combined immunodeficiency (SCID) syndrome, common variable immunodeficiency (CVID) syndrome, cartilage hair hypoplasia syndrome, or HIV\u002FAIDS\n4. History of histiocytosis, including Langerhans cell histiocytosis (LCH), or hemophagocytic lymphohistiocytosis (HLH)\n5. History of ischemic cholangitis\n6. History of portal vein thrombosis with biliopathy, veno-occlusive disease, or abdominal radiation vasculopathy\n7. History of recurrent pyogenic cholangitis\n8. History of biliary tract surgery for cholecystolithiasis prior to cholangiogram\u002Fliver biopsy evaluated to determine enrollment\n9. History of biliary tract surgery for choledochal cyst\n10. History of hepatocellular carcinoma, or hepatoblastoma\n11. History of surgical biliary trauma\n12. History of congenital cytomegalovirus (CMV) hepatitis\n13. History of Sickle Cell Disease\n14. History of cystic fibrosis, biliary atresia, Caroli disease\u002Fcongenital hepatic fibrosis, or progressive familial intrahepatic cholestasis type 3\u002FMDR3 disease\n15. History of cardiac hepatopathy.\n16. History of metabolic disorders, including Wilson's disease, glycogen storage disorder, Alpha-1 Antitrypsin deficiency\n17. Diagnosis of systemic lupus erythematosus (SLE)\n18. Concurrent pregnancy at the time of enrollment -","2 Years","25 Years",{"count":80,"type":22},1000,"Primary sclerosing cholangitis (PSC) is a rare liver disease that damages the liver's bile ducts. Bile ducts are tiny tubes that carry bile from the liver to the small intestine. Bile is a liquid produced by the liver that helps us absorb and use the nutrients in the food we eat. In people with PSC, the bile backs up into the liver and will damage it, causing scarring of the liver.\n\nThe purposes of this study are to:\n\n* Collect medical and other data to learn more about PSC, how it progresses, and identify factors that may cause the disease to progress more quickly.\n* Ask questions about how PSC symptoms affect your child's life to learn more about its impact on your child's daily functioning\n* Children with PSC who are seen at one of the participating clinical sites in the Childhood Liver Disease Research Network (ChiLDReN) will be asked to contribute information, DNA, and other specimens. The information and specimens will be available to investigators to carry out approved research aimed at learning more about the possible causes and long-term effects of PSC.",[28,83,84],"Liver Diseases","Cholangitis, Sclerosing",[86,28],"Pediatric Liver Disease","2026-06-03",{"date":89,"type":33},"2026-06-04",{"date":91,"type":33},"2021-12-30",{"date":93,"type":22},"2029-05-31",{"name":95,"class":96},"Arbor Research Collaborative for Health","OTHER",12,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":69},"100531247","early-phase-1-evaluation-of-an-oral-microbiota-based-therapeutic-as-a-treatment-option-for-psc-100531247","NCT06197308","Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for PSC","Evaluation of an Oral Microbiota-based Therapeutic as a Treatment Option for Primary Sclerosing Cholangitis","Inclusion Criteria:\n\n* Ages 18-76\n* Serum total bilirubin at screening ≤ 2x the upper limit of normal\n* Absence of biliary obstruction and malignancy by ultrasound or equivalent imaging within 6 months of study entry\n* Anticipated maintenance of current medication regimen through the treatment period (UDCA, azathioprine, corticosteroid, methotrexate, 5-ASA, biologic therapy and\u002For probiotic)\n* 3-month washout period of obeticholic acid or other experimental therapies for PSC\n* Stated willingness to comply with all study procedures and availability for the duration of trial to follow-up by telephone, in-person, email, and\u002For video visits or correspondence.\n* Informed consent\n\nExclusion Criteria:\n\n* Antibiotic therapy (except vancomycin) within 3 months or anticipated antibiotic use in the course of the MTT treatment\n* Presence of complications of advanced PSC, such as hepatic encephalopathy, ascites, history of esophageal varices, portal hypertension, hepato-renal syndrome, portopulmonary syndrome, and hepato-pulmonary syndrome\n* Evidence for viral hepatitis (history of Hepatitis C is eligible with undetectable HCV RNA); HIV\u002FAIDS\n* Metabolic or inherited liver disease (e.g., Wilson's, hemochromatosis, alpha-1-antitrypsin deficiency)\n* Another disease involving bile ducts (e.g., primary biliary cholangitis, IgG4-related cholangitis, secondary sclerosing cholangitis)\n* Evidence of cirrhosis on the last magnetic resonance cholangiopancreatography (within 6 months)\n* Pregnancy or attempting to become pregnant or breastfeeding.\n* History of liver transplantation, anticipated need for liver transplantation within 12- months from randomization, or a Model of End Stage Liver Disease (MELD) score of ≥15\n* Active malignancy\n* Active alcohol overuse (\\>4 drinks per day for men, and \\>2 drinks per day for women)\n* Moderate-to-severe renal impairment with a calculated creatinine clearance of \\\u003C 45 mL\u002Fmin\n* Neutropenia (an absolute neutrophil count \\\u003C 0.5 x 109 cells\u002FL)\n* History of allergic reaction to vancomycin\n* History of allergic reaction to amoxicillin or other beta-lactam antibiotics\n* Any other conditions or abnormalities that, in the opinion of the investigator, may compromise the safety of the subject or interfere with the subject participating in or completing the study\n* Total colectomy","76 Years",{"count":107,"type":22},28,[109],"EARLY_PHASE1","This pilot clinical trial will evaluate the initial safety and feasibility of microbiota transplant therapy (MTT) inpatients with primary sclerosing cholangitis (PSC). This trial will inform development of future trials in treatment of PSC.",[28],"2026-05-18",{"date":114,"type":33},"2026-05-20",{"date":116,"type":33},"2024-03-01",{"date":118,"type":22},"2027-09-01",{"name":120,"class":96},"University of Minnesota",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":23,"phases":131,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":145},"100538121","phase-2-faecal-microbiota-transplantation-in-primary-sclerosing-cholangitis-100538121","NCT06286709","FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis","FARGO: A Randomised, Phase IIa, Multi-centre, Placebo-controlled Trial of FAecal Microbiota Transplantation in primaRy sclerosinG chOlangitis","FARGO","Inclusion Criteria:\n\n1. Written informed consent\n2. Age ≥ 18 years\n3. Participants must be able to understand and comply with the purpose and procedures that are involved in the trial\n4. An established diagnosis of colonic inflammatory bowel disease, with willingness to participate in an annual colonoscopic surveillance program, as per routine standard of care\n5. An established clinical diagnosis of large duct PSC, with compatible features as assessed by magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP)\n6. A persistent ALP value above normal (at least 2 readings at this value over 6 months before screening)\n7. Evidence of early to moderate stage liver fibrosis, as suspected by any of the following:\n\n   1. Median VCTE score of ≤14.4kPa, with an interquartile range ≤30%\n   2. Previous liver biopsy indicating at an absence of established cirrhosis, Ishak fibrosis stage \\\u003CIV (or equivalent) in the last 24 months\n   3. Serum enhanced liver fibrosis score (ELF) ≤9.8\n8. A colonoscopy showing no evidence of dysplasia\u002Fneoplasia within 24 months before screening\n9. No evidence of active colitis, as evidenced by a Partial Mayo Score of ≤4, with a score of \\\u003C2 on the rectal bleeding domain at screening\n10. Individuals with IBD who are receiving treatment with biologics, immunosuppression or corticosteroids must be taking a stable dose for at least twelve weeks prior to screening, and be expected to remain on the same medication\u002Fsame dose for the duration of the trial\n11. Individuals with PSC having overlapping features of autoimmune hepatitis may be included, provided:\n\n    1. The dosage of immunosuppression has remained stable for at least twelve weeks prior to screening, and be expected to remain on the same medication\u002Fsame dose for the duration of the trial; and\n    2. There is evidence of concomitant colitis\n\nExclusion Criteria:\n\n1. Secondary causes of sclerosing cholangitis including, but not limited to, IgG4-related cholangitis, cholangiopathy due to acquired immunodeficiency syndrome, drug-induced sclerosing cholangitis, trauma, ischaemic cholangiopathy, choledocholithiasis (investigator discretion), or sclerosing cholangiopathy as a sequelae of hepatopancreatobiliary resection\n2. Other causes of liver disease, including, but not limited to, IgG4-related disease; viral hepatitis; alcohol-related liver disease; clinically significant metabolic associated fatty liver disease (at investigator discretion); drug-induced liver disease; hereditary haemochromatosis; alpha-1-antitrypsin disease; primary biliary cholangitis; Wilson disease; Budd-Chiari Syndrome; or primary or secondary hepatopancreatobiliary cancer\n3. Presence of a clinically significant dominant stricture based on the combination of radiological, biochemical and clinical features. Patients can be included in the trial with a dominant extrahepatic stenosis if it has been stable for 6 months or more (as evidenced on imaging and also clinically), and one of the following are satisfied:\n\n   1. The PI does not plan for any biliary intervention (endoscopic, percutaneous or surgical) for the duration of the trial OR\n   2. The investigator decides that they do not wish to perform any biliary intervention (endoscopic, percutaneous or surgical) on the dominant stenosis for clinical reasons of stability\u002Fpatient choice\n4. Presence of a percutaneous drain or bile duct stent\n5. Evidence of hepatic decompensation within twelve weeks prior to screening; or concern by the Principal Investigator that the participant may decompensate during the trial period. Hepatic decompensation as evidenced by variceal haemorrhage, ascites, hepatic hydrothorax, or hepatic encephalopathy (Appendix 1)\n6. Biochemical\u002Flaboratory evidence of very advanced hepatic dysfunction, as evidenced by a serum bilirubin value \\>55 µmol\u002FL (unless Gilbert Syndrome or another condition associated with unconjugated hyperbilirubinaemia, including but not limited to, spherocytosis and disorders of bilirubin conjugation where a bilirubin value\\>45 µmol\u002FL is allowable), serum albumin \\\u003C32 g\u002FL, platelet level of \\\u003C140x109\u002FL, Child-Turcotte-Pugh (CTP) score \\>B7, or a MELD score \\>15\n7. Ascending cholangitis as assessed clinically within twelve weeks of screening\n8. Use of antibiotics within twelve weeks of screening\n9. Participant already listed for liver transplantation, or concerns (investigator discretion) that they may need to be listed for liver transplantation during the trial period\n10. Small duct PSC\n11. Advanced-stage liver fibrosis, as evidenced by a VCTE score \\>14.4kPa, a liver biopsy showing \\>Ishak stage III fibrosis (or equivalent)\n12. Significant renal dysfunction as evidenced by an estimated glomerular filtration rate of \\\u003C60 ml\u002Fmin according to the Cockcroft-Gault formula, or need for dialysis\n13. Human Immunodeficiency Virus (HIV) infection\n14. A symptomatic positive test result for Serious Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in the four weeks prior to screening\n15. History of malignancy within the past three years, or ongoing malignancy, other than non-melanomatous skin cancer, or treated cervical carcinoma in situ\n16. Any history of small bowel or colonic resection, or likelihood of resection during the trial period. Individuals with a sub-total colectomy and ileal pouch anal anastomosis are permitted to participate.\n17. Patients who are pregnant or breastfeeding\n18. Women of childbearing potential (see Appendix 2 for definition) who confirm they are not willing to practise effective contraception (see Appendix 3 for further details) for the duration of the trial and for four weeks after the last dose of trial drug. Women who are taking hormonal contraception must confirm stable formulation and dosage for at least 6 weeks prior to treatment\n19. Alcohol consumption \\>21 units per week for men, and \\>14 units per week for women.\n20. Positive urine drug screen at screening\n21. Positive stool test for Clostridioides Difficile toxin or microscopy\u002Fculture positivity for enteric infection within twelve weeks prior to screening\n22. Participation in an interventional trial, or use of a non-licensed investigational agent for any indication within twelve weeks before screening, or five half-lives of the investigational drug, whichever is longer\n23. Newly introduced or a change in dosage of any of the following medications within twelve weeks of screening: fibric acid derivatives, farnesoid X-receptor agonists, anti-gastrointestinal motility agents (e.g., loperamide or opioids), bile acid sequestrants (e.g. colestyramine) or ursodeoxycholic acid (UDCA)\n24. Use of any of the following medications within twelve weeks of screening: oral or intravenous antibiotics, including (but not limited to) vancomycin, rifaximin, rifampicin and metronidazole; probiotic or prebiotic preparations, including (but not limited to) VSL#3 and Symprove",{"count":130,"type":22},58,[132],"PHASE2","FARGO is a randomised, phase IIa, multi-centre, placebo-controlled trial to compare Faecal Microbiota Transplant (FMT) with placebo in patients with primary sclerosing cholangitis (PSC) and concomitant inflammatory bowel disease.",[28,135],"Inflammatory Bowel Diseases","2026-04-28",{"date":138,"type":33},"2026-04-29",{"date":140,"type":33},"2024-03-27",{"date":142,"type":22},"2027-02-28",{"name":144,"class":96},"University of Birmingham",5,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":48,"sex":17,"minAge":154,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":157,"conditions":158,"keywords":163,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":69},"100555982","liver-gut-axis-study-through-identification-of-liver-disease-specific-microbiome-100555982","NCT06519162","Liver-gut Axis Study Through Identification of Liver Disease-specific Microbiome","Exploration of Liver-gut Axis Through Identification of Liver Disease-specific Microbiome","LGAS","Inclusion Criteria:\n\n* Adults aged 19 years and older diagnosed with autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, non-alcoholic fatty liver disease, or liver abscess, who have consented to participate in this study at Chungnam National University Hospital.\n* Adults aged 19 years and older, who are cohabitants of patients diagnosed with autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, non-alcoholic fatty liver disease, or liver abscess, and have consented to participate in this study at Chungnam National University Hospital.\n\nB. Exclusion\n\nExclusion Criteria:\n\n* Individuals under the age of 19.\n* Patients or guardians who do not consent to participate in the study","19 Years",{"count":156,"type":22},3000,"In this study, we aim to identify gut microbiomes specific to patients with chronic refractory liver disease and to conduct a gut-liver axis study on the pathogenesis and disease progression.",[159,28,160,161,162],"Autoimmune Hepatitis","Non-Alcoholic Fatty Liver Disease","Liver Abscess","Primary Biliary Cirrhosis",[83,164,165],"Microbiota","Immune System","2026-03-19",{"date":168,"type":33},"2026-03-20",{"date":170,"type":33},"2024-07-08",{"date":172,"type":22},"2029-07-08",{"name":174,"class":96},"Chungnam National University Hospital",{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":48,"sex":17,"minAge":18,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":23,"phases":185,"briefSummary":187,"conditions":188,"keywords":190,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":69},"100610617","phase-1-a-study-of-tak-781-in-healthy-volunteers-and-in-participants-with-non-cirrhotic-primary-sclerosing-cholangitis-psc-100610617","NCT07229911","A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)","A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Sponsor-Open Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-781 in Healthy Participants and a Single-Arm, Open-Label Evaluation in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis","Inclusion Criteria: Phase 1a (SAD and MAD)\n\n1. The participant is willing and able to fully comply with all trial procedures and requirements, in the investigator's opinion.\n2. The participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form (ICF) or electronic consent \\[e-consent\\] if applicable) and any required privacy authorization prior to the initiation of any trial procedures.\n3. Male at birth and female at birth participants aged 18 to 68 years, inclusive, at the time of consent.\n4. The participant is judged to be in good health (for example, no evidence of cardiovascular, liver, metabolic, gastroenterological, or kidney disease) by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, ECG, and vital sign measurements performed at the first screening visit.\n5. The participant must have a body mass index (BMI) of less than 30.0 kilograms per square meter (kg\u002Fm\\^2) at the time of screening.\n6. Has not had frequent or heavy use (that is, near-daily) of medical or recreational cannabis for at least 3 months before screening.\n7. The participant must not be a person of childbearing potential (POCBP) defined by at least 1 of the following criteria:\n\n   * Surgically sterile for at least 6 weeks at screening (defined as having undergone one of the following procedures: hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).\n   * Postmenopausal at screening (defined as no menses for 12 months without an alternative medical cause). A high follicle-stimulating hormone (FSH) level (greater than or equal to \\[\\>=\\]40 international units\u002Fliter \\[IU\u002FL\\] in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.\n   * Has no uterus as a result of congenital condition. The participant must not donate ova for at least 6 months after the last dose of trial intervention.\n8. Male participants (based on sex at birth) must use highly effective contraception, from the date of signing the ICF, throughout the duration of the trial, and for 6 months after the last dose of trial intervention. The participant must not donate sperm for at least 6 months after the last dose of trial intervention.\n\nInclusion Criteria: Phase 1b (Non-Cirrhotic PSC)\n\n1. The participant is willing and able to fully comply with all trial procedures and requirements, in the investigator's opinion.\n2. The participant has provided informed consent (that is, in writing, documented via a signed and dated ICF or e-consent if applicable) and any required privacy authorization prior to the initiation of any trial procedures.\n3. Male at birth and female at birth participants aged 18 to 68 years, inclusive, at the time of consent.\n4. Confirmed diagnosis of large-duct PSC based on any 2 of the following 3 criteria:\n\n   * Historical evidence of an elevated alkaline phosphatase (ALP) greater than \\[\\>\\] upper limit of normal (ULN) from any laboratory.\n   * Historical liver biopsy with histologic features consistent with large-duct PSC, in the appropriate clinical context (such as cholestatic liver enzyme profile, inflammatory bowel disease \\[IBD\\] history).\n   * Historical abnormal cholangiography consistent with PSC as measured by magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography, or percutaneous transhepatic cholangiography.\n5. The participants must have a fibrogenesis biomarker over pre-defined level.\n6. The participants must have evidence for moderate\u002Fadvanced fibrosis but not cirrhosis as defined by enhanced liver fibrosis (ELF) \\>=7.7 but less than or equal to(\\\u003C=)11.3 at Visit 1.\n7. No evidence of cholangiocarcinoma or any other malignancy on magnetic resonance imaging (MRI) at screening.\n8. Participants with a certain concomitant disease are allowed to enroll if pre-defined criteria are met.\n9. Participants must have certain additional laboratory parameters in specified ranges at screening.\n10. Has not had frequent or heavy use (that is, near-daily) of medical or recreational cannabis for at least 3 months before screening.\n11. A female and male participant (based on sex at birth) must use highly effective contraception, from the date of signing the ICF, throughout the duration of the trial, and for 6 months after the last dose of trial intervention. The participant must not donate ova or sperm for at least 6 months after the last dose of trial intervention.\n12. A POCBP must have a negative serum pregnancy test at first screening visit and urine pregnancy test on second screening visit and Day 1 before dosing.\n13. Participants must be able to be educated regarding the correct process\u002Fprocedure, verbally state understanding and comply with the correct process\u002Fprocedure of the administration SC IP for the duration of the trial.\n\nExclusion Criteria: Phase 1a (SAD and MAD)\n\n1. The participant is an employee of the sponsor or trial site, or an immediate family member (for example, spouse, parent, child, sibling) of an employee of the sponsor or trial site who is directly involved in the conduct of the trial.\n2. The participant has a known hypersensitivity to any component of the formulation of TAK-781 or related compounds.\n3. The participant has a history of significant multiple and\u002For severe allergies (for example, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food.\n4. The participant has a history or clinical evidence of bleeding diathesis or any coagulation disorder.\n5. The participant has a medical history of prior cholecystectomy.\n6. The participant has participated in another investigational trial with other investigational agents or devices for any indication within 4 weeks or within 5 half-lives, for investigational drugs or biologics with a known half-life (whichever is longer), before the screening visit. The interval window from the previous trial will be derived from the date of the last trial medical procedure, and\u002For AE related to the trial IP or procedure in the previous trial to the screening visit of the current trial. Exceptions may be made for observational, natural history and nonintervention type studies with sponsor or designee approval.\n7. The participant has an ALT and\u002For AST value greater than the ULN during screening.\n8. The participant has abnormal cholesterol: total cholesterol \\>240 milligrams per deciliter (mg\u002FdL), low-density lipoprotein cholesterol (LDL-C) (\\>160 mg\u002FdL), high-density lipoprotein cholesterol (HDL-C) (less than \\[\\\u003C\\]35 mg\u002FdL), and triglycerides (\\>250 mg\u002FdL) at screening. Lipid parameters may be repeated once under fasting conditions at the principal investigator's discretion. Eligibility will be determined based on the repeated results.\n9. The participant has eGFR rate \\\u003C=90milliliter per minutes per 1.73 square meters (mL\u002Fmin\u002F1.73m\\^2) at screening.\n10. The participant screening ECG (triplicate) reveals a QT interval with Fridericia correction method (QTcF) \\>450 millisecond (ms) (male) or \\>460 ms (female).\n11. The participant has a history of torsades de pointes, clinically significant ventricular arrhythmias (for example, ventricular tachycardia), heart block (excluding first-degree atrioventricular block), congenital long QT syndrome, or clinically significant ischemic ECG changes, including new ST-segment elevation or depression or new Q waves, as determined by the investigator. Benign ECG variants, such as early repolarization patterns, are not exclusionary if they occur without clinical symptoms or other evidence underlying cardiac disease.\n12. The participant has a confirmed supine systolic blood pressure \\>=140 millimetres of mercury (mmHg) and\u002For diastolic blood pressure \\>=90 mmHg at screening. If the participant's supine blood pressure exceeds these thresholds, the measurement should be repeated twice after the participant has remained in the supine position for at least 10 minutes. The average of the three supine blood pressure measurements will be used to determine eligibility.\n\n    Resting BP is defined as a BP measurement obtained after the participant has been resting for a minimum of 5 minutes.\n13. The participant has a resting heart rate (HR) outside of the range of 55 to 100 beats per minute (bpm) (inclusive) at screening, confirmed on repeat testing within a maximum of 30 minutes. Athletic participants with HR \\\u003C55 bpm may be enrolled based on the investigator's judgement provided that the HR is \\>45 bpm.\n14. The participant has a positive urine screen for drugs of abuse at screening and Day -3.\n15. History of any malignancy diagnosed or treated within 5 years prior to screening.\n16. The participant consumes excessive amounts (defined as greater than 600 milligram (mg) of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day.\n17. Has a positive pregnancy test result during the screening period.\n18. Participants who test negative for hepatitis B surface antigen (HBsAg) but positive for hepatitis B core antibody (HBcAb) would be considered eligible if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) results are negative at screening (as confirmed by HBV DNA polymerase chain reaction \\[PCR\\] reflex testing performed by the central laboratory). Participants with positive HBV DNA test results will not be eligible.\n19. Participants who test positive for hepatitis C virus (HCV) ribonucleic acid (RNA) at screening. Participants who are hepatitis C antibody (HCVAb) positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured \\[defined as no evidence of HCV RNA at least 12 weeks before screening Visit1\\]).\n20. The participant tests positive for human immunodeficiency virus (HIV) at screening or currently receiving antiretroviral therapy.\n21. Has undergone major surgery or donated or lost 1 unit of blood (approximately 500 milliliters \\[mL\\]) within 4 weeks before the screening visit.\n22. Currently has or previously had a significant illness, as judged by the investigator, within 2 weeks of the first dose of trial intervention.\n23. The participant is unable to refrain from or anticipates using prohibited or excluded medications, herbal preparations, grapefruit juice, and other restricted substances or the required washout period prior to administration of the first dose of trial intervention throughout the trial and until the follow-up visit.\n24. The participant is unable to refrain from or anticipate using smoking, vaping or nicotine-containing products 2 weeks before screening until the last follow-up visit.\n25. Clinically relevant drug or alcohol abuse within 12 months of screening.\n\n    * A positive drug screen is exclusive unless it can be explained by a prescribed medication.\n    * Participant with alcohol consumption greater than 4 units on any day or 14 units per week for male participants, or greater than 3 units on any day or 7 units per week for female participants \\[1 unit of alcohol is present in one 12 ounce (oz)\u002F355 mL beer (approximately 5 percent (%) alcohol), one 5 oz\u002F148 mL glass of wine (approximately 12% alcohol), and one 1.5 oz\u002F44 mL measure of 80-proof liquor (approximately 40% alcohol)\\].\n\nExclusion Criteria: Phase 1b (Non-Cirrhotic PSC)\n\n1. Presence of documented secondary sclerosing cholangitis (such as ischemic cholangitis, recurrent pancreatitis, intraductal stone disease, severe bacterial cholangitis, surgical or blunt abdominal trauma, recurrent pyogenic cholangitis, cholelithiasis, choledocholithiasis, toxic sclerosing cholangitis due to chemical agents, or any other cause of secondary sclerosing cholangitis) on prior clinical investigations.\n2. Immunoglobulin G4-related Sclerosing Cholangitis based on historical diagnosis.\n3. Evidence of compensated cirrhosis. All participants will undergo a standardized cirrhosis exclusion assessment during screening including clinical, laboratory, and imaging evaluation (non-contrast MRI\u002F magnetic resonance elastography \\[MRE\\], MRCP+), documented using a predefined cirrhosis checklist completed and signed by both the site Principal Investigator (or Sub-Investigator) and the site radiologist. For participants with ELF \\>9.8 to \\\u003C=11.3 and\u002For liver stiffness measurement (LSM) \\>12.5 kilopascals (kPa), the checklist findings will undergo enhanced review by the sponsor medical monitor, who will provide final eligibility confirmation. A hepatic adjudication committee may be consulted in cases of ambiguity or disagreement. Participants will be excluded if \\>=2 of the following cirrhosis-associated features are present:\n\n   * MRE liver stiffness \\>= 4.32 kPa.\n   * Liver surface nodularity or lobar redistribution.\n   * Spleen volume \\>400 mL\u002Fm\\^2 body surface area or spleen length \\>13 centimeter (cm).\n   * Segmental parenchymal signal heterogeneity, periportal edema, or lobar atrophy.\n   * Collateral vessels or signs of portal hypertension (for example, varices, recanalized umbilical vein).\n   * Radiologist overall impression consistent with cirrhosis.\n   * Serum albumin \\\u003C3.5 grams per deciliter (g\u002FdL).\n4. The participant has a medical history of prior cholecystectomy.\n5. Participants will be excluded if they meet any of the following criteria: a diagnosis of decompensated liver disease, or evidence of new signs of decompensation or clinically meaningful deterioration in liver function during the screening period, based on the judgment of the investigator. This may include, but is not limited to, significant changes in the following parameters: total bilirubin, direct bilirubin, albumin, international normalized ratio (INR), creatinine, alanine transaminase (ALT), or aspartate transaminase (AST).\n6. Presence or history of any of the following:\n\n   * Ascites.\n   * Hepatic encephalopathy.\n   * Variceal bleeding.\n   * Child-Pugh score \\>6 (Class B or C), unless elevated INR is attributable to therapeutic anticoagulation. (Participants with compensated cirrhosis \\[for example, Child-Pugh A\\] will also be excluded if identified via the noninvasive cirrhosis exclusion algorithm, which includes assessment of ELF score, LSM, MRI\u002FMRE, MRCP+, and clinical\u002Flaboratory parameters).\n   * Model for End-Stage Liver Disease score \\>11.\n7. Concomitant overlap syndrome with autoimmune hepatitis as diagnosed at screening by AST or ALT \\>5\\*ULN, and historical:\n\n   * Positive smooth muscle antibody and\u002For liver-kidney microsomal antibody (LKM), or\n   * Immunoglobulin G (IgG) \\>ULN, or\n   * Biopsy suggestive for autoimmune hepatitis.\n8. Concomitant overlap syndrome with primary biliary cholangitis (PBC) as diagnosed by either historical:\n\n   * Positive anti-mitochondrial autoantibodies, or\n   * Biopsy suggestive for PBC.\n9. Clinically significant acute or chronic liver disease of an etiology other than PSC.\n10. Presence of a dominant stricture of clinical concern on MRCP at screening. However:\n\n    \\- Participants with dominant stricture could be enrolled if the investigator determines that there is no evidence on MRI or cholangiography indicative of cholangiocarcinoma or that the stricture will likely not result in significant fluctuations in ALP during screening or trial period.\n11. Placement of a bile duct stent or percutaneous bile duct drain within 3 months of screening. However:\n\n    \\- Participants who had undergone a stricture balloon dilation procedure can enroll in the trial after at least 4 weeks post procedure.\n12. History, evidence, or high suspicion of cholangiocarcinoma or other hepatobiliary malignancy based on imaging, laboratory values, and\u002For clinical symptoms.\n13. Ascending cholangitis within 60 days prior to screening and through Day 1. However:\n\n    * Chronic preventive antibiotics for cholangitis are allowed in the trial.\n    * Intermittent courses of antibiotics for the presumptive treatment of cholangitis are allowed if outside the 12-week window prior to screening.\n14. Prior liver transplantation.\n15. Screening ECG with clinically significant abnormalities as determined by the investigator.\n16. Participants who test negative for HBsAg but positive for HBcAb would be considered eligible if HBV DNA results are negative at screening (as confirmed by HBV DNA PCR reflex testing performed by the central laboratory). Participants with positive HBV DNA test results will not be eligible.\n17. Participants who test positive for HCV RNA at screening. Participants who are HCVAb positive without evidence of HCV RNA may be considered eligible (spontaneous viral clearance or previously treated and cured \\[defined as no evidence of HCV RNA at least 12 weeks before baseline\\]).\n18. The participant tests positive for HIV at screening or currently receiving antiretroviral therapy.\n19. History of malignancy diagnosed or treated within 5 years prior to screening.\n20. The participant is unable to refrain from or anticipates using prohibited or excluded medications, herbal preparations, grapefruit juice, and other restricted substances or the required washout period prior to administration of the first dose of trial intervention throughout the trial and until the follow-up visit.\n21. The participant has not had frequent or heavy use (\\>=20 cigarettes per day) of smoking, vaping or nicotine-containing products or has not smoking-related complications.\n22. Clinically relevant drug or alcohol abuse within 12 months of screening.\n\n    * A positive drug screen is exclusive unless it can be explained by a prescribed medication.\n    * Participant with alcohol consumption greater than 4 units on any day or 14 units per week for male participants, or greater than 3 units on any day or 7 units per week for female participants \\[1 unit of alcohol is present in one 12 oz\u002F355 mL beer (approximately 5% alcohol), one 5 oz\u002F148 mL glass of wine (approximately 12% alcohol), and one 1.5 oz\u002F44 mL measure of 80-proof liquor (approximately 40% alcohol)\\].\n23. Use of any prohibited concomitant medication is not allowed unless the participant has completed the washout period prior to Day 1.\n24. Participants should not be currently taking ursodeoxycholic acid, unless they have completed the washout period prior to Day 1.\n25. Severe allergic or anaphylactic reactions to any components of N-acetylgalactosamine small-interfering RNA therapeutics.\n26. Use of any investigational drug, biologic, or medical device, or participation in an interventional clinical trial, is prohibited within 4 weeks prior to screening or within 5 elimination half-lives for investigational drugs or biologics with a known half-life (whichever is longer). This restriction includes any pharmacologic, endoscopic, or other interventional procedures intended to modify or alter the course of PSC or its underlying disease processes.\n27. History of clinically significant unstable or untreated illness or any other major medical disorder that may have interfered with participant treatment, assessment, or compliance with the protocol.\n28. Any acute or chronic condition or other disease that, in the opinion of the investigator, would limit the ability of the participant to complete and\u002For participate in the clinical trial.\n29. Presence of any other conditions (for example, geographic or social), actual or projected, that the investigator determines would restrict or limit the participation of the participant for the duration of the trial.\n30. Individuals who are employed by the sponsor, a participating contract research organization (CRO), or the trial site - including permanent staff, temporary or contract workers, or designees directly involved in the conduct of the trial are excluded from participation. This exclusion also applies to immediate family members of employees of the sponsor, CRO, or trial site.","68 Years",{"count":184,"type":22},134,[186],"PHASE1","The main aim of this study is to see if the drug TAK-781 is safe for healthy volunteers and for participants with PSC. The study will also look at how well participants can tolerate TAK-781. In addition, the study will check how the body absorbs, uses, and gets rid of TAK-781 (Pharmacokinetics \\[PK\\]), how the drug affects the body (Pharmacodynamics \\[PD\\]), and how the body's immune system reacts to TAK-781 (Immunogenicity).\n\nThe study consists of two phases (Phase 1a and 1b). Phase 1a includes two parts: Part 1 (Single Ascending Dose \\[SAD\\]) and Part 2 (Multiple Ascending Dose \\[MAD\\]). In Part 1, healthy participants will receive either single dose of TAK-781 or a placebo. A placebo looks the same as TAK-781 but has no medicine in it. In Part 2, healthy participants will receive multiple doses of TAK-781 or a placebo. In Phase 1b (Part 3), participants with large duct, non-cirrhotic PSC will receive a single dose of TAK-781.\n\nParticipants will be in the study for about 36 weeks.",[189,28],"Healthy Volunteers",[191],"Drug Therapy","2026-03-03",{"date":194,"type":33},"2026-03-05",{"date":196,"type":33},"2026-01-07",{"date":198,"type":22},"2028-04-06",{"name":200,"class":40},"Takeda",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":48,"sex":17,"minAge":18,"maxAge":208,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":214,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":69},"100509358","early-phase-1-statin-therapy-in-primary-sclerosing-cholangitis-psc-a-multi-omics-study-100509358","NCT05912387","Statin Therapy in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study","The Effect of Statin Therapy on Bile Acid Physiology and the Microbiome in Primary Sclerosing Cholangitis (PSC): a Multi-omics Study","Inclusion Criteria:\n\n* Males and females, greater than or equal to 18 years of age\n* Established diagnosis of PSC, defined by either appropriate cholangiographic findings or supportive liver biopsy plus an established diagnosis of inflammatory bowel disease (IBD - Crohn's disease or ulcerative colitis) per American College of Gastroenterology (ACG) guidelines for the PSC-IBD arm\n* Hypercholesterolemia with BMI \\\u003C 25.0 for the comparison arm\n\nExclusion Criteria:\n\n* Diagnosis of PSC-autoimmune hepatitis overlap syndrome\n* Woman who are pregnant, nursing, or expect to be pregnant\n* The presence of any comorbidity known to cause secondary sclerosing cholangitis, including: immunoglobulin G-4 (IgG4), associated cholangitis, recurrent bacterial cholangitis, recurrent pyogenic cholangitis, ischemic cholangiopathy, surgical biliary trauma, cholangiocarcinoma, and portal hypertensive biliopathy\n* Diagnosis of a serious medical condition (unless approved in writing by a physician)\n* Patients taking statin therapy prior to study initiation\n* Patients with known clinically allergy to statin therapy\n* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 times the upper limit of normal\n* Bilirubin greater than 3.0 mg\u002FdL\n* Recent use of antibiotics (within the last 90 days)\n* Concurrent use of any immunosuppressive medications (such as any calcineurin inhibitor, steroids at a dose greater than 10 mg of prednisone-equivalents per day)\n* Actively using a fibrate drug\n* Actively using a ritonavir containing drug\n* Familial hypercholesterolemia or other inherited disorder of lipid metabolism\n* Recent myocardial infarction or cerebrovascular accident\n* Body mass index \\> 25.0 for the comparison arm\n* Chronic kidney disease stage 5 or end-stage renal disease","80 Years",{"count":210,"type":22},15,[109],"PSC is a liver disease that has no medical cure. Patients with PSC are at a greatly increased risk of cancer and infection. Additionally, many patients require a liver transplant. Progress towards a cure has been severely limited by an incomplete understanding of why patients develop PSC. The investigators aim to close this gap by conducting a pilot human study in patients with PSC, using statin therapy as a model",[28,135],[215],"Statin","2026-02-23",{"date":218,"type":33},"2026-02-27",{"date":220,"type":33},"2023-05-31",{"date":222,"type":22},"2027-12-31",{"name":224,"class":96},"Stanford University",{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":48,"sex":17,"minAge":18,"maxAge":231,"enrollmentInfo":232,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":69},"100420380","characterization-of-biliary-cell-derived-organoids-from-bile-of-psc-and-non-psc-patients-100420380","NCT04753996","Characterization of Biliary Cell-derived Organoids From Bile of PSC and Non-PSC Patients","Inclusion Criteria:\n\nPSC\n\n* Patients diagnosed with PSC between the age of 18 and 85.\n* The diagnosis of PSC will be based on standard PSC criteria including clinical and biochemical evidence of chronic cholestasis of at least six months duration, positive cholangiographic findings and compatible liver biopsies if available.\n* Women with PSC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation. Patients with PSC and Cholangiocarcinoma will be included.\n\nControls\n\n• Controls without history of PSC or evidence of other chronic liver disease of either gender that will participate in this study should be between the ages of 18-85.\n\nExclusion Criteria:\n\n* Patients unable to provide inform consent.\n* Prisoners and institutionalized individuals.\n* PSC with orthotopic liver transplantation\n* History of Roux En Y procedure","85 Years",{"count":233,"type":22},300,"The purpose of this research is to create a collection of bile, bile duct brushings and medical information from people with Primary Sclerosing Cholangitis (PSC) and controls to learn more about changes that occur in the liver.",[28,236,237],"PSC","Cholangiocarcinoma","2026-02-12",{"date":240,"type":33},"2026-02-17",{"date":242,"type":33},"2021-03-08",{"date":244,"type":22},"2035-01-01",{"name":246,"class":96},"Mayo Clinic",{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":4,"eligibilityCriteria":253,"healthyVolunteers":48,"sex":17,"minAge":18,"maxAge":231,"enrollmentInfo":254,"targetDuration":256,"studyType":52,"phases":4,"briefSummary":257,"conditions":258,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":69},"100319960","biobank-for-cholestatic-liver-diseases-100319960","NCT03445585","Biobank for Cholestatic Liver Diseases.","A Resource of Blood and Other Biospecimens of Patients With Cholestatic Liver Disease and Unaffected Individuals","Inclusion Criteria:\n\nPSC\n\n* Patients diagnosed with PSC and who are between the age of 18 and 85 at time of enrollment in the study.\n* The diagnosis of PSC will be based on standard PSC criteria including clinical and biochemical evidence of chronic cholestasis of at least six months duration, positive cholangiographic findings, and compatible liver biopsies if available.\n* Patients with PSC who have undergone orthotopic liver transplantation will be offered enrollment except for collection of bile - please see below under Exclusion Criteria.\n* Women with PSC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.\n\nPBC\n\n* Patients diagnosed with PBC and who are between the age of 18 and 85 at time of enrollment in the study.\n* The diagnosis of PBC will be based on standard PBC criteria including clinical and biochemical evidence of chronic cholestasis of at least six month duration, positive anti-mitochondrial antibodies in serum and compatible liver biopsies, if available.\n* Patients with PBC who have undergone orthotopic liver transplantation will be offered enrollment except for collection of bile - please see below under Exclusion Criteria.\n* Women with PBC of childbearing potential and pregnant women will be offered enrollment because there is no risk to an unborn child in this investigation.\n\nControls\n\n* Controls without history of PBC, PSC, or evidence of other chronic liver disease of either gender that participate in this study will be between the ages of 18 and 85.\n\nLiver Disease Controls\n\n* Patients without history of PBC or PSC but do have evidence of other chronic liver disease of either gender will be offered participation in this study if between the ages of 18 and 85.\n\nExclusion Criteria (all subjects):\n\n* PBC or PSC patients with known and overlapping other chronic liver diseases\n* Patients unable to provide informed consent\n* Prisoners and institutionalized individuals\n\nExclusion Criteria (for bile collection during ERCP)\n\n* PSC with orthotopic liver transplantation\n* History of Roux en Y",{"count":255,"type":22},9150,"20 Years","This study is a biobank of specimens and clinical data for use in current and future research to better understand the cholestatic liver diseases primary biliary cirrhosis\u002Fcholangitis (PBC) and primary sclerosing cholangitis (PSC).",[28,162,237,259],"Liver Cancer",{"date":240,"type":33},{"date":262,"type":4},"2017-01",{"date":264,"type":22},"2050-01",{"name":246,"class":96},{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":23,"phases":276,"briefSummary":277,"conditions":278,"keywords":283,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":69},"100551068","phase-1-a-study-of-siplizumab-in-aild-and-lt-patients-100551068","NCT06455280","A Study of SIPLIZUMAB in AILD and LT Patients","A 12-Month, Open-Label Study Evaluating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Siplizumab as Induction Therapy in Patients With Autoimmune Liver Diseases Undergoing Liver Transplantation (SET-SAIL)","SET-SAIL","Inclusion Criteria:\n\n1. Able to provide informed consent\n2. Age ≥ 18 years old\n3. Clinical diagnosis of AIH and\u002For PSC\n4. Listed for liver transplantation\n5. Epstein-Barr virus (EBV) seropositive within 12 months of screening\n\nExclusion Criteria:\n\n1. Presence or history of significant liver disease other than AIH or PSC, including viral hepatitis, alcohol-related liver disease and biopsy-proven non-alcoholic steatohepatitis\n2. Prior transplant\n3. Listed for multiorgan transplant\n4. Acute liver failure\n5. Known malignancy, including cholangiocarcinoma and hepatocellular carcinoma\n6. Other investigational products in the last 30 days or 5 half lives\n7. Pregnant\u002Flactating or unwilling to use contraception\n8. Leukopenia (WBC less than 2,000\u002Fmm3\n9. Absolute lymphocyte count \\\u003C 200\u002Fmm3\n10. Sero-positive for HIV-1\n11. Hepatitis C Virus (HCV) antibody or RNA positive (within 6 months of screening)\n12. HBsAg, hepatitis B virus (HBV) DNA or HBcAb positive (within 6 months of screening)\n13. Alcohol use exceeding 30g\u002Fday for men or 20g\u002Fday for women, and\u002For known phosphatidylethanol (PETH) level \\>80 in the 3 months prior to LT\n14. Untreated latent TB infection as detected by QuantiFERON Gold Plus Interferon Gamma Release Assay (IGRA) (or current standard interferon gamma release assay for TB)\n15. Receipt of any live-attenuated vaccine within 2 months of transplant.\n\nADDITIONAL exclusion criteria to be reviewed at the time of transplant\n\n1. Renal failure with dialysis or with estimated glomerular filtration rate (eGFR) \\\u003C 30 at the time of LT\n2. Model for end-stage liver disease (MELD)-Na score \\>30\n3. Donor features of Donation after Cardiac Death (DCD), HCV Ab or nucleic acid testing (NAT+), HBcAb or HBsAg+, or blood types A, B, and O incompatible organ",{"count":275,"type":22},8,[186],"There is a significant unmet need for safe and effective therapeutic approaches to prevent immune-mediated graft injury and its complications in liver transplant (LT) recipients with autoimmune liver disease (AILD) including autoimmune hepatitis and primary sclerosing cholangitis. Siplizumab is an anti-cluster of differentiation 2 (CD2) monoclonal antibody that has demonstrated a favorable safety profile of siplizumab in over 779 human subjects and has been shown to target memory T cells-a key driver in the immune processes surrounding rejection and autoimmunity post LT in AILD. The purpose of this pilot, open-label phase 1 study is to determine the safety of siplizumab for induction in patients with AILD undergoing LT.\n\nUp to eight (8) subjects will receive siplizumab 0.6 mg\u002Fkg\u002Fdose on the day of transplant (Day 0) and Day 4 post-transplant, for a total of two doses.\n\nAll subjects will be followed in the study for 12 months post-LT.",[279,280,159,28,281,282],"Autoimmune Liver Disease","Liver Transplant Disorder","End Stage Liver DIsease","Cirrhosis, Liver",[279,280,159,28,281,282],"2025-11-19",{"date":286,"type":33},"2025-11-24",{"date":288,"type":33},"2024-09-11",{"date":290,"type":22},"2028-03-31",{"name":292,"class":96},"Elizabeth C. Verna",{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":302,"briefSummary":303,"conditions":304,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":69},"100503457","phase-2-detoxification-of-the-liver-in-psc-dolphin-100503457","NCT05835505","Detoxification of the Liver In PSC (Dolphin)","Detoxification of the Liver in Primary Sclerosing Cholangitis","DOLPHIN","Inclusion Criteria:\n\n* A diagnosis of PSC for at least 6 months based upon cholangiography (ERCP or MRCP) demonstrating intrahepatic and\u002For extrahepatic biliary strictures, beading or irregularity consistent with PSC.\n* ALP \\> 1.5 times the upper limit of normal (ULN) at screening.\n* Subject must either be on a stable dose of ursodeoxycholic acid for \\> 6 months prior to screening or have been discontinued \\> 4 weeks prior to screening (enrollment of patients who are on UDCA will be limited to 60% of all enrolled patients).\n\nExclusion Criteria:\n\n* Anticipated need for liver transplant within one year as determined by Mayo PSC risk score\n* Evidence of decompensated liver disease such as variceal bleeding, ascites, or hepatic encephalopathy.\n* Evidence of advanced liver disease including MELD score \\> 10, bilirubin \\> 3.0, platelet count \\\u003C 100,000; or INR \\> 1.4\n* Concomitant chronic liver disease including alcohol related liver disease, chronic hepatitis B or C infection, haemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency, non-alcoholic steatohepatitis, autoimmune hepatitis, or primary biliary cholangitis\n* Secondary causes of sclerosing cholangitis\n* Patients who have a confirmed malignancy or cancer within 5 years except non-melanoma skin cancers\n* Treatment with any investigational agents, within two months or 5 half-lives of the investigational product, whichever is longer.\n* Active illicit drug or more than moderate alcohol consumption.\n* Evidence of bacterial cholangitis within 6 months of enrollment\n* In patients with Ulcerative Colitis, or, if Crohn's disease, a need for additional therapy at time of screening.\n* Chronic kidney injury (eGFR \\\u003C 60)\n* Pregnancy or lactation\n* Uncontrolled hypertension with a systolic BP \\> 140 and a systolic BP \\> 90\n* Prohibited medications: current use of vitamin C and prednisone\n* Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease\n* Patients with a history of kidney stones\n* Congenital or acquired immunodeficiencies\n* Other comorbidities including: diabetes mellitus, systemic lupus\n* An episode of acute cholangitis within 4 weeks of screening Check eligibility here: https:\u002F\u002Fredcap.link\u002FCheckmyeligibility",{"count":107,"type":22},[132],"This study is a clinical trial being done to investigate the efficacy of drug BRS201 (hydroxocobalamin) as a treatment in patients with primary sclerosing cholangitis. Participation in this study will take 8 weeks long and the study is structured as a cross-over study in which participants will take the study drug for 4 weeks and a placebo drug for 4 weeks in a randomized order in the form of an oral medication. Participation may also involve receiving an IV dose of the medication. The study will require participants to attend 9 study visits, all of which will be remote. Participation will involve taking an oral medication twice daily, tracking the medication in a log, and getting blood drawn and giving a stool sample for a few lab tests throughout the study. For the lab tests, a research nurse will visit the participant in-home for the convenience of the participant.",[28],"2025-11-04",{"date":307,"type":33},"2025-11-06",{"date":309,"type":33},"2023-12-12",{"date":311,"type":22},"2026-12-01",{"name":313,"class":96},"Brigham and Women's Hospital",{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":17,"minAge":322,"maxAge":323,"enrollmentInfo":324,"targetDuration":4,"studyType":23,"phases":326,"briefSummary":327,"conditions":328,"keywords":331,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":69},"100506576","phase-2-vancomycin-in-primary-sclerosing-cholangitis-in-italy-100506576","NCT05876182","Vancomycin in Primary Sclerosing Cholangitis in Italy","A Prospective, Randomized, Placebo-controlled Clinical Trial of Oral Vancomycin in Adults and Young Adults (15-17 Years Old) Affected by Primary Sclerosing Cholangitis With or Without Inflammatory Bowel Disease","VanC-IT","Inclusion Criteria:\n\n1. Willing and able to give informed consent prior to any study specific procedure being performed;\n2. Male and non-pregnant, non-lactating female subjects, including women of child bearing potential (WOCBP), between 15-70 years of age at the time of informed consent;\n3. Diagnosis of large-duct PSC based on cholangiogram (at MRCP, ERCP, PTC) according to the most recent published guidelines (EASL);\n4. Baseline ALP ≥1.5 times upper limit normal at screening;\n5. Absence of biliary obstruction and\u002For malignancy within 6-12 months of entry into the study;\n6. If a patient is on ursodeoxycholic acid (UDCA) or 5-aminosalicylic acid he or she is expected to remain on the same daily dose during the study period;\n7. Patients who received antibiotics or probiotics may participate if they had a washout period of at least 3-month prior to study entry;\n8. If a patient has been on obeticholic acid or other experimental therapies (e.g. cilofexor and norUDCA) for PSC, they must complete a 3-month washout period before study entry;\n9. PSC with or without IBD. IBD diagnosis should be documented and with a minimum disease duration of 6 months, as determined by endoscopic and histopathology assessment. IBD should be in clinical remission or mildly active according to CDAI and partial Mayo score for CD and UC, respectively (i.e. patients with CDAI score \\\u003C 220 and pMayo score \\\u003C5). Patients without documented IBD need a colonoscopy with segmental biopsies within 12 months prior to baseline visit;\n10. Female subjects of childbearing potential must test negative for pregnancy at screening, baseline and follow-up visits and if engage in sexual intercourse must agree to use specific methods of contraception.\n11. Male subjects with female partners of childbearing potential must use condoms during treatment and until the end of relevant systemic exposure.\n\nExclusion Criteria:\n\n1. Receiving an antibiotic or probiotic within 3 months prior to the study;\n2. Expected to receive antibiotics within the weeks leading up to enrollment (such as patients with recurrent cholangitis, ongoing infectious illnesses, etc.);\n3. Allergy to vancomycin or teicoplanin;\n4. Biliary intervention within 3 months prior to study enrollment or planned;\n5. Alcohol abuse (defined as greater than 14 standard drinks units per week in men; greater than 7 standard drinks units per week);\n6. Pregnancy and lactation;\n7. Advanced renal disease (GFR\\\u003C 70);\n8. Active hepatitis B and\u002For C infection;\n9. Other chronic or cholestatic liver diseases such as PBC, autoimmune hepatitis, nonalcoholic steatohepatitis, alcoholic liver disease, Wilson's disease, hemochromatosis, α-1 antitrypsin deficiency, IgG4-related sclerosing cholangitis, and liver cancer;\n10. History of CCA;\n11. Advanced liver disease (history of variceal bleeding, ascites, hepatic encephalopathy, and\u002For bilirubine \\>4 mg\u002FdL);\n12. On active transplantation list;\n13. IBD with uncontrolled moderate to severe activity;\n14. Active treatment or within the previous four weeks (washout period) with any immunosuppressive medication for controlling IBD (i.e. azathioprine, 6-mercaptopurine, tacrolimus, methotrexate, infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, ozanimod). Treatment with corticosteroids (including budesonide, budesonide MMX and beclomethasone) in the previous four weeks\n15. Active treatment with rifampicin or within the previous three months (washout period);\n16. Dose change within last 3 months prior to baseline of concomitant treatment with vitamin D or fibrates;\n17. Treatment with any experimental drug within the previous three months;\n18. Any known relevant infectious disease (e.g. active tuberculosis, AIDS defining disease);\n19. History or active hearing problems;\n20. Any active malignant disease;\n21. Well found doubt about patient's cooperation, e.g. addiction to alcohol or drugs;\n22. Imprisoned person, person admitted to nursing homes, persons under legal guardianship, and persons not able to express their consent.","15 Years","70 Years",{"count":325,"type":22},84,[132],"Primary sclerosing cholangitis (PSC) is chronic fibroinflammatory disease of the liver. There is still no medical therapy proven to halt the progression of PSC or prevent its serious complications.\n\nThis is a Phase 2 randomized, double bind, placebo-controlled, monocentric study evaluating the safety and efficacy of two doses of oral vancomycin (i.e. 750 mg and 1500 mg\u002Fday) in subject between 15 - 70 years old with PSC.",[28,329,330],"Liver and Intrahepatic Bile Duct Disorder","IBD",[332,333,334,335],"liver","oral vancomycin","primary sclerosing cholangitis","Inflammatory bowel disease","2025-07-24",{"date":338,"type":33},"2025-07-25",{"date":340,"type":33},"2023-06-15",{"date":342,"type":22},"2026-06",{"name":344,"class":96},"University of Milano Bicocca",{"id":346,"slug":347,"hasResults":11,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":353,"targetDuration":355,"studyType":52,"phases":4,"briefSummary":356,"conditions":357,"keywords":358,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":372,"completionDateStruct":374,"leadSponsor":376,"locationsCount":275},"100496919","a-link-improving-outcomes-in-autoimmune-liver-disease-100496919","NCT05750498","A-LiNK: Improving Outcomes in Autoimmune Liver Disease","Autoimmune Liver Disease Network for Kids (A-LiNK): Using Patient Data to Transform Care and Improve Outcomes for Children, Adolescents, and Young Adults With Autoimmune Liver Disease","ALINK","Inclusion Criteria:\n\n* Clinical diagnosis of autoimmune hepatitis (AIH)\n* Clinical diagnosis of primary sclerosing cholangitis (PSC)\n* Clinical diagnosis of autoimmune sclerosing cholangitis (ASC)\n\nExclusion Criteria:\n\n• History of liver transplant",{"count":354,"type":22},800,"10 Years","The Autoimmune Liver disease Network for Kids (A-LiNK) is a multi-institutional group with the mission to deliver the best care to kids with pediatric autoimmune liver disease (AILD).\n\nThis study will establish a shared clinical registry and a learning health network for the participating sites focusing on collecting and transmitting clinical measurement data, information about processes, and participation in an improvement collaborative.\n\nPediatric Autoimmune Hepatitis (AIH) and Primary Sclerosing Cholangitis (PSC), represent a spectrum of AILD which present unique diagnostic and therapeutic challenges.A lack of accepted guidelines for disease monitoring or symptom management results in wide treatment variation with liver transplants indicated in refractory, progressive disease.\n\nThe aims of A-LiNK are to:\n\n1.) Create a learning health network focused on patient-centered outcomes research characterized by transparent sharing among centers, common priorities, and feasible plans for implementing new practices; 2) shift from traditional investigator-driven study to a patient and family-centered approach, and 3.) improve clinical outcomes and quality of life for pediatric AILD patients.",[159,28],[359,159,28,360,361,362,363,364,365,366,367,368,369],"Pediatrics","Autoimmune Sclerosing Cholangitis","Chronic Liver Disease","End-stage Liver Disease","Clinical Registry","Research Registry","Quality Improvement","Outcomes Research","Comparative Effectiveness Research","Patient Reported Outcomes","Health Services Research","2025-07-21",{"date":336,"type":33},{"date":373,"type":33},"2022-04-28",{"date":375,"type":22},"2033-06-30",{"name":377,"class":96},"Children's Hospital Medical Center, Cincinnati",{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":385,"targetDuration":4,"studyType":23,"phases":387,"briefSummary":388,"conditions":389,"keywords":392,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":399,"lastUpdatePostDateStruct":400,"startDateStruct":402,"completionDateStruct":404,"leadSponsor":406,"locationsCount":69},"100585645","phase-2-pharmacologic-approaches-to-preventing-primary-sclerosing-cholangitis-recurrence-after-liver-transplantation-100585645","NCT06905054","Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation","Peroxisome Proliferator-Activated Receptor Agonists to Prevent Primary Sclerosing Cholangitis Recurrence After Liver Transplantation","Inclusion criteria:\n\n* Adults aged 18-75 irrespective of gender who have undergone LT for PSC or PSC-related liver malignancy between 1 year and 7 years (inclusive) prior to study enrollment\n* Absence of rPSC at time of study enrollment\n* At least one of the following additional features that increase risk of rPSC\n\n  * LT performed for cholangiocarcinoma\n  * Concurrent inflammatory bowel disease\n  * Any episode of cytomegalovirus viremia in the post-transplant period before study enrollment\n  * Any episode of acute cellular rejection in the post-transplant period before the study enrollment\n* If target enrollment of 40 patients is not achieved during the first 6 months of study, we will remove f(iii) inclusion criteria to expand enrollment to any patient meeting the other inclusion\u002Fexclusion criteria.\n* Due to lab requirements, we will only enrol patients who are within a 3 hour driving distance of Mayo Clinic Arizona and\u002For are willing to travel to Mayo Clinic Arizona at 4 month intervals during the study at own cost.\n\nExclusion criteria:\n\n* Presence of ischemic cholangiopathy which can mimic rPSC\n* LT performed for primary biliary cholangitis or autoimmune hepatitis, or PSC with overlapping primary biliary cholangitis or autoimmune hepatitis, which may recur after LT and confound assessment of cholestasis\n* Unaddressed post-LT hepatic artery compromise (e.g thrombosis, stenosis) which can mimic rPSC\n* History of total colectomy for curative treatment of ulcerative colitis which reduces risk of rPSC\n* Baseline GFR \\\u003C30 ml\u002Fmin which precludes administration of fenofibrate\n* Previously known intolerance or allergy to fenofibrate\n* Other clinically significant comorbid condition, including inability to provide consent and psychiatric conditions, which in the opinion of the study team, may interfere with patient treatment, safety, assessment, or compliance with the treatment\n* Female participants that are pregnant or planning to become pregnant",{"count":386,"type":22},80,[132],"This study aims to determine the efficacy of 36 months once-daily fenofibrate in preventing clinically-detectable recurrence of primary sclerosing cholangitis after liver transplantation, compared with a historical control cohort that was not treated with",[28,390,236,391],"Liver Transplant, Complications","Biliary Strictures",[334,393,394,395,396,397,398],"recurrent primary sclerosing cholangitis","liver transplant complication","fenofibrate","fibrate","PPAR agonist","peroxisome proliferated activated receptor agonist","2025-06-25",{"date":401,"type":33},"2025-06-27",{"date":403,"type":33},"2025-04-15",{"date":405,"type":22},"2028-07-01",{"name":246,"class":96},{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":17,"minAge":415,"maxAge":19,"enrollmentInfo":416,"targetDuration":4,"studyType":23,"phases":417,"briefSummary":418,"conditions":419,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":429},"100461978","phase-2-oral-hymecromone-to-treat-adolescents-and-adults-with-primary-sclerosing-cholangitis-100461978","NCT05295680","Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis.","A Study of Oral Hymecromone to Treat Adolescents and Adults With Primary Sclerosing Cholangitis(HAAPS Study).","HAAPS","Inclusion Criteria:\n\n* Diagnosis of primary sclerosing cholangitis confirmed by liver biopsy and\u002For imaging study\n* If history of endoscopically confirmed inflammatory bowel disease, currently stable based on Mayo Score \u002F Disease Activity Index (DAI) for Ulcerative Colitis Score ≤ 1, normal inflammatory markers (ESR, CRP and fecal calprotectin) and stable non-excluded medical therapy for at least 6 months\n\nExclusion Criteria:\n\n* Currently receiving biologic therapies\n* Known allergy to hymecromone\n* Cholangiocarcinoma\n* Pregnancy\n* Serious liver disease","14 Years",{"count":5,"type":22},[132],"Primary objective: To evaluate the efficacy of hymecromone plus standard of care compared with standard of care alone in the treatment of adolescents and adults with primary sclerosing cholangitis (PSC).\n\nSecondary objectives: To evaluate the change in Alkaline Phosphatase (ALP) from baseline to 6 months post-treatment following treatment with hymecromone plus standard of care compared with standard of care.\n\nTo evaluate changes in biomarkers of PSC disease during hymecromone treatment, namely: (a) fibrotic effect (FibroScan); (b) inflammatory biomarkers (serum Hyaluronan (HA)); and, (c) T-cell count.",[28],"2025-06-11",{"date":422,"type":33},"2025-06-13",{"date":424,"type":33},"2023-05-10",{"date":426,"type":22},"2027-12",{"name":428,"class":96},"Aparna Goel",2,{"id":431,"slug":432,"hasResults":11,"nctId":433,"briefTitle":434,"officialTitle":435,"acronym":436,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":323,"enrollmentInfo":438,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":440,"conditions":441,"keywords":445,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":459},"100568007","leopard-training-and-validation-data-collection-study-100568007","NCT06675604","LEOPARD Training and Validation Data Collection Study","Data Collection to Design and Validate LEOPARD Predictive Models of Delisting in Liver Transplant Candidates","LEOPARD TVDCS","Inclusion Criteria:\n\n* Adult \\[age 18;70\\] patients listed for:\n\n  * decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology (subset 1) OR\n  * other chronic end-stage liver diseases requiring LT, to be listed under a MELD-based allocation system (examples: primary biliary cholangitis, primary sclerosing cholangitis etc…) (subset 2) OR\n  * HCC\\* as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis (subset 3). (HCC diagnosed on Barcelona\u002FEASL criteria or histologically proven. HCC meeting or not Milan criteria, as per center practice.)\n* Patients registered on national waiting lists under the MELD offering schemes, regardless of extra MELD points and MELD exceptions are affected or not.\n* Patient (or trusted person, family member or close relation, if the patient is unable to be informed) who has been informed and did not express opposition to data collection\n\n(\\*Of note, enrolment of patients with T1 tumors (1 single tumor \\\u003C 2 cm diameter) not amenable to loco-regional therapies because of decompensation, and prioritized under the MELD system, will be allowed in Subset 1.)\n\nExclusion Criteria:\n\n* Tumor vascular invasion (portal or hepatic veins) evidenced by imaging at pre transplantation work-up, including portal vein thrombosis stage 1\n* Extra-hepatic metastasis of HCC, as assessed by sectional imaging, functional imaging (18 FDG PET CT\u002FMRI) or histologically proven\n* Patients who are under safeguard of justice or tutorship or curatorship\n* Patient on AME (state medical aid)\n* Participation to LEOPARD PVC 1 study of WP2",{"count":439,"type":22},4500,"Intro:\n\nThe present clinical research protocol is part of the LEOPARD European project (Grant n° 101080964 Horizon Europe) which aims to design and validate new predictive models of mortality among liver transplantation (LT) candidates. MELD based-liver graft allocation systems have become increasingly inaccurate over the last decade to predict mortality\u002Fdropout of liver transplantation (LT) candidates on the waitlist (WL). Wide disparities in mortality\u002Fdropout on the WL also exist across European countries, ranging from 5 to 30% according to transplantation indications and countries. In this setting, the European Commission- Horizon Europe funded-LEOPARD project intends to design new, 2nd generation, AI-machine learning-based predictive models of delisting in LT candidates, to better serve on time patients with the highest risk of dropout on the WL and to improve equity of access to LT across Europe.\n\nHypothesis\u002FObjective:\n\nThe scientific justification of the LEOPARD TVDCS is therefore to collect a large set of data in liver transplantation candidates listed in Europe a) to design and b) to validate LEOPARD 2nd generation AI-based predictive models of mortality\u002Fdropout The primary objective is to develop new predictive models of mortality\u002Fdrop out on the waitlist in patients with decompensated cirrhosis, or other end-stage chronic liver diseases, and in patients listed for Hepato-cellular carcinoma (HCC).\n\nMethod:\n\nLongitudinal multicenter prospective health care data collection cohort study in 2 sets : Training\u002Fdevelopment set : Prospective health care data collection in 3,000 patients listed in 50 centres across 7 countries and Validation set: Prospective health care data collection in 1,500 subsequent patients listed in the same 50 centres.",[442,443,28,444],"Decompensated Liver Cirrhosis","Primary Biliary Cholangitis","Hepato-cellular Carcinoma",[446,447,448,449],"Liver transplantation","predictive models","data collection cohort","liver transplantation candidates","2025-05-06",{"date":452,"type":33},"2025-05-09",{"date":454,"type":33},"2025-02-04",{"date":456,"type":22},"2029-02-04",{"name":458,"class":96},"Assistance Publique - Hôpitaux de Paris",22,{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":23,"phases":469,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":472,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":4},"100584209","phase-3-study-with-norucholic-acid-tablets-in-patients-with-primary-sclerosing-cholangitis-psc-100584209","NCT06886360","Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)","An Open-label Study of Patients with Primary Sclerosing Cholangitis (PSC) Treated with Norucholic Acid Tablets","Inclusion criteria:\n\n1. Signed informed consent.\n2. Males or females ≥ 18 years.\n3. Patient has previously been diagnosed with PSC, has participated in the previous NUC 5\u002FPSC trial and has completed the DBE phase with Visit 22, or has prematurely terminated the DBE phase before this trial has been started, or has prematurely terminated the DBE phase after this trial has been started, under the condition that the premature termination was due to lack of efficacy\\*. (\\*Lack of efficacy as defined in the NUC-5\u002FPSC trial.)\n\nExclusion Criteria:\n\n1. History or presence of chronic alcoholic consumption (daily consumption \\> 30 g in men, \\> 20 g in women).\n2. Patients who discontinued study participation in NUC-5\u002FPSC due to an AE possibly caused by the study drug.\n3. Liver Cirrhosis or any cirrhosis-related symptoms which in the opinion of the investigator may affect the patient's safety.\n4. History of liver transplantation or patient listed for transplantation.",{"count":468,"type":22},120,[25],"Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis",[28],"NOT_YET_RECRUITING","2025-03-19",{"date":475,"type":33},"2025-03-20",{"date":477,"type":22},"2025-03",{"date":479,"type":22},"2027-09",{"name":481,"class":40},"Dr. Falk Pharma GmbH",{"id":483,"slug":484,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":323,"enrollmentInfo":490,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":492,"conditions":493,"keywords":494,"overallStatus":472,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":145},"100571670","leopard-prospective-validation-cohort-1-100571670","NCT06723275","LEOPARD Prospective Validation Cohort 1","Validation of LEOPARD Predictive Models of Delisting in Liver Transplant Candidates: the LEOPARD Longitudinal Multicentre Prospective Validation Cohort 1, with Bio- and Tissue Collection","LEOPARD PVC1","Inclusion Criteria:\n\n* Adult \\[age 18;70\\] patients listed for:\n\n  * decompensated cirrhosis as primary diagnosis, irrespective of liver disease etiology (subset1) OR\n  * other end-stage liver diseases requiring LT, listed under MELD offering schemes (subset 2), including notably but not exclusively cholestatic diseases, primary biliary cholangitis, primary sclerosing cholangitis (subset 2) OR\n  * HCC as primary diagnosis, whatever the etiology of the underlying liver disease with or without underlying cirrhosis (subset 3). (HCC diagnosed on Barcelona\u002FEASL criteria or histologically proven. HCC meeting or not Milan criteria, as per center practice.)\n* Patients registered on national waiting lists under the MELD offering schemes, regardless of extra MELD points are affected or not.\n* Patient (or trusted person, family member or close relation, if the patient is unable to express consent) who has been informed and signed the informed consent.\n* Patient affiliated with a health insurance scheme (beneficiary or entitled party).\n\nExclusion Criteria:\n\n* Tumor vascular invasion (portal or hepatic veins) evidenced by imaging on pre transplantation work-up, including PVT stage 1\n* Extra-hepatic metastasis of HCC, as assessed by sectional imaging, functional imaging (18 FDG PET CT\u002FMRI) or histologically proven\n* Women who are pregnant or nursing\n* Patients who are under safeguard of justice or tutorship or curatorship\n* Patient on AME (state medical aid)\n* Participation in another trial including other studies proposed as part of the European LEOPARD project (cohort associated to WP1 \\& WP5 (\"LEOPARD TVDCS\") or being in the exclusion period following previous interventional research involving the human person, if applicable",{"count":491,"type":22},630,"Intro:\n\nThe present clinical research protocol is part of the LEOPARD European project (Grant n° 101080964 Horizon Europe) which aims to design and validate new predictive models of mortality among liver transplantation (LT) candidates.\n\nMELD based-liver graft allocation systems have become increasingly inaccurate over the last decade to predict mortality\u002Fdropout of liver transplantation (LT) candidates on the waitlist (WL). Wide disparities in mortality\u002Fdropout on the WL also exist across European countries, ranging from 5 to 30% according to transplantation indications. In this setting, the European Commission- Horizon Europe funded-LEOPARD project intends to design new, 2nd generation, AI-machine learning-based predictive models of delisting in LT candidates, to better serve on time patients with the highest risk of dropout on the WL and to improve equity of access to LT across Europe.\n\nHypothesis\u002FObjective The scientific justification of the LEOPARD PVC1 is therefore\n\n1. to build an external cohort of LT candidates to test and validate the LEOPARD models, therefore providing robust evidence for adoption of LEOPARD models by Organ Sharing Organizations (OSOs).\n2. to collect granular data, bio- and tissues sampes and images to test last-generation OMICs predictors and radiomics, therefore opening the door to design of 3rd generation, precision medicine-based predictive models.\n\nThe primary objective of the LEOPARD longitudinal study is to test and validate AI-based 2nd generation LEOPARD predictive models of mortality\u002Fdrop out on the waitlist in patients with decompensated cirrhosis, or other end-stage chronic liver diseases, and in patients listed for HCC.\n\nMethod Multicenter Prospective longitudinal study in up to 630 enrolments (in case of replacing participants after inclusion) to obtain 600 patients meeting selection criteria, in 30 hospitals in 5 European countries including France, Italy, The Netherlands, Belgium and Germany.",[442,443,28,444],[446,495,496,497],"Predictive models","Liver transplantation candidates","prospective longitudinal study","2024-12-10",{"date":500,"type":33},"2024-12-13",{"date":502,"type":22},"2025-01",{"date":504,"type":22},"2027-10",{"name":458,"class":96},{"id":507,"slug":508,"hasResults":11,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":11,"sex":17,"minAge":513,"maxAge":514,"enrollmentInfo":515,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":69},"100299483","mri-biomarkers-in-as-predictor-of-clinical-endpoints-in-pediatric-autoimmune-liver-disease-100299483","NCT03178630","MRI Biomarkers in as Predictor of Clinical Endpoints in Pediatric Autoimmune Liver Disease","Longitudinal Study for the Assessment of MRI Based Biomarkers as a Predictors of Clinical Endpoints in Pediatric Onset Autoimmune Liver Disease","Inclusion Criteria:\n\n1. Age 6-23 years old.\n2. Established clinical diagnosis of AIH or PSC.\n\nExclusion Criteria:\n\n1. History of liver transplantation.\n2. Chronic Hepatitis B or untreated hepatitis C virus infection.\n3. Pregnancy.\n4. Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia).\n5. Diagnosis of cystic fibrosis or biliary atresia\n6. Diagnosis of cardiac hepatopathy.\n7. Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease.\n8. Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).","6 Years","23 Years",{"count":516,"type":22},150,"Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factor for chronic liver disease among adolescents. This is a longitudinal study to identify surrogate endpoints with an accurate predictive value for the progression of hepatobiliary damage in subjects with pediatric onset AILD. This study will involve collection of MRI-based data at the time of enrollment and at year 1 and 2 of follow up, and collection of clinical data for 10 years following enrollment. There is a strong possibility that MRI quantitative techniques may be more sensitive to disease progression than standard clinical and laboratory tests. To investigate predictivity of MRI based biomarkers, summary measures of MRCP\u002FMREL from baseline, Year 1 and Year 2, e.g. change rate, maximum, and average will be calculated as predictors for Year 10 clinical outcomes. The same predictors will also be used to model native liver survival in a proportional hazard regression. Findings from this study may be used to assess disease progression and to predict complications and survival of liver disease patients.",[279,159,28],"2024-12-09",{"date":521,"type":33},"2024-12-12",{"date":523,"type":33},"2017-02-20",{"date":525,"type":22},"2031-02",{"name":377,"class":96},{"id":528,"slug":529,"hasResults":11,"nctId":530,"briefTitle":531,"officialTitle":532,"acronym":4,"eligibilityCriteria":533,"healthyVolunteers":11,"sex":17,"minAge":513,"maxAge":514,"enrollmentInfo":534,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":536,"conditions":537,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":538,"startDateStruct":539,"completionDateStruct":541,"leadSponsor":543,"locationsCount":69},"100299240","mri-based-biomarkers-in-pediatric-autoimmune-liver-disease-100299240","NCT03175471","MRI Based Biomarkers in Pediatric Autoimmune Liver Disease","Cross-sectional Study for Assessment of MRI Based Biomarkers of Bile Duct Injury and Hepatic Fibrosis in Pediatric Onset Autoimmune Liver Disease","Inclusion Criteria:\n\n1. Age 6-23 years old.\n2. Established or suspected clinical diagnosis of AIH or PSC.\n\nExclusion Criteria:\n\n1. History of liver transplantation.\n2. Chronic Hepatitis B or untreated hepatitis C virus infection.\n3. Pregnancy.\n4. Absolute contraindication for MRI (e.g. pacemaker, metallic implants, claustrophobia).\n5. Diagnosis of cystic fibrosis or biliary atresia\n6. Diagnosis of cardiac hepatopathy.\n7. Diagnosis of Wilson's disease, Alpha-1 Antitrypsin deficiency, or Glycogen storage disease.\n8. Skin conditions which could be aggravated by MREL (i.e. Epidermolysis bullosa).",{"count":535,"type":22},115,"Autoimmune liver diseases (AILD), which include Primary Sclerosing Cholangitis (PSC) and Autoimmune Hepatitis (AIH) are a common etiological factors for chronic liver disease among adolescents. In all these conditions, autoimmune lymphocyte responses are thought to orchestrate inflammatory injury against hepatocytes (primarily in AIH) or cholangiocytes (in PSC). In this proposal we aim to evaluate the Magnetic Resonance Imaging (MRI) modalities; MR cholangiopancreatography (MRCP) and MR elastography (MREL), as non-invasive biomarkers to assess two primary pathophysiological processes of AILD: bile duct damage and liver fibrosis. In this cross-sectional study MRI based findings of bile duct injury and liver fibrosis will be correlated with both liver histology and circulating biomarkers of these disease processes.",[279,28,159],{"date":521,"type":33},{"date":540,"type":33},"2017-01-17",{"date":542,"type":22},"2027-01-30",{"name":377,"class":96},{"id":545,"slug":546,"hasResults":11,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":11,"sex":17,"minAge":551,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":554,"conditions":555,"keywords":556,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":567},"100486751","national-database-on-primary-sclerosing-cholangitis-psc-100486751","NCT05618145","National Database on Primary Sclerosing Cholangitis (PSC)","Multicenter, Nationwide, Observational, Prospective Study Based on the Development of a Primary Sclerosing Cholangitis Patient's Database Linked to a Biological Sample Storage","Inclusion Criteria:\n\n* Willing and able to give informed consent prior to any study specific procedure being performed;\n* Diagnosis of PSC according to the most recent published guidelines (EASL);\n\nExclusion Criteria:\n\n* Subject unwilling to participate at the study","17 Years",{"count":553,"type":22},6000,"Primary sclerosing cholangitis (PSC) a rare, chronic fibroinflammatory disease of the liver.\n\nNo data about the disease epidemiology exist in Italy. Therefore this study aims to develop a national PSC patient database linked to a biological sample storage.",[28],[28,557,558],"Disease phenotypes","National Database","2023-12-29",{"date":561,"type":33},"2024-01-02",{"date":563,"type":33},"2022-10-21",{"date":565,"type":22},"2032-10-21",{"name":344,"class":96},63,{"id":569,"slug":570,"hasResults":11,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":23,"phases":578,"briefSummary":580,"conditions":581,"keywords":4,"overallStatus":472,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":4},"100474760","clinical-application-of-annual-liver-multiscan-and-mrcp-in-primary-sclerosing-cholangitis-100474760","NCT05462093","Clinical Application of Annual Liver Multiscan and MRCP+ in Primary Sclerosing Cholangitis","Clinical Application of Annual Liver Multiscan and MRCP+ in Primary Sclerosing Cholangitis: the CATCH-IT Study","CATCH-IT","Inclusion Criteria:\n\n* Established PSC diagnosis according to the IPSCSG definitions\n* Age ≥ 18\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Post LTx\n* Known allergy for MRI contrast agents, implants non-compatible with MRI or extreme claustrophobia causing discontinuation of MRI studies.",{"count":577,"type":22},200,[579],"NA","Primary sclerosing cholangitis (PSC) is a chronic progressive biliary disease that affects approximately 1200 patients in the Netherlands and around 80,000 in the Western world. It is often accompanied by ulcerative colitis (UC) or Crohn's disease affecting the large bowel. The cause of PSC is unknown, there is no medical therapy available that has proven to halt disease progression and the median time until death or liver transplantation is 13-21 years.\n\nDiagnosis is made by magnetic resonance cholangiography (MRC), or in the case of so called small duct disease by liver biopsy.\n\nDue to the heterogeneous disease course and the relatively low clinical event rate of 5% per year it is difficult to predict prognosis of individual patients or to recommend any surveillance strategy for malignancies. Also, the lack of surrogate endpoints impedes performing clinical research. Recently, two new post-processing tools have been developed to characterize and quantify abnormalities in the biliary tree as well as excretory function captured by MRC. These tools called MRCP+ (quantitative magnetic resonance cholangiopancreatography +) and LiverMultiscan (LMS) hold the prospect of adequately depicting and quantifying lesions of the biliary tree as well as capturing functional derailment. However, several features must be tested before the utility of this tools in clinical patient care can be concluded. Therefore, the aim of this study is to investigate the utility of these novel techniques in monitoring disease activity by performing consecutive annual MRI's.",[28],"2022-07-13",{"date":584,"type":33},"2022-07-18",{"date":586,"type":22},"2022-07",{"date":588,"type":22},"2029-07",{"name":590,"class":96},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":592,"slug":593,"hasResults":11,"nctId":594,"briefTitle":595,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":48,"sex":17,"minAge":598,"maxAge":599,"enrollmentInfo":600,"targetDuration":4,"studyType":23,"phases":601,"briefSummary":602,"conditions":603,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":69},"100219718","phase-1-treating-primary-sclerosing-cholangitis-and-biliary-atresia-with-vancomycin-100219718","NCT02137668","Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin","The Human Gastrointestinal Tract Microbiota in the Setting of Treating Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin","Inclusion Criteria:\n\n* Persons who have primary sclerosing cholangitis, biliary atresia, a chronic intestinal disorder or who are undergoing upper or lower endoscopy.\n* Persons who have primary sclerosing cholangitis or biliary atresia who are good candidates for vancomycin therapy.\n\nExclusion Criteria:\n\n* Patients that have taken antibiotics and\u002For immunomodulators within the last 3 months will be excluded as this will alter the original bacterial flora.\n* Females who are pregnant may not participate.","2 Weeks","40 Years",{"count":577,"type":22},[186],"The purpose of this study is twofold. First, is to determine whether vancomycin is effective in the early treatment of Biliary Atresia (BA) and Primary Sclerosing Cholangitis (PSC), and if so, by what mechanism. Secondly, to characterize human intestinal microbial communities and their interactions with the host.",[28,604],"Biliary Atresia","2016-11-10",{"date":607,"type":22},"2016-11-15",{"date":609,"type":4},"2010-07",{"date":611,"type":22},"2028-07",{"name":613,"class":96},"Sacramento Pediatric Gastroenterology"]