[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-sclerosing-cholangitis-psc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-sclerosing-cholangitis-psc":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,53,85,113,143,168,197,221,245],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100645171","phase-2-the-safety-and-efficacy-of-upadacitinib-in-refractory-autoimmune-related-cholangitis-and-atopic-dermatitis-with-moderate-to-severe-itching-100645171",false,"NCT07678645","The Safety and Efficacy of Upadacitinib in Refractory Autoimmune Related Cholangitis and Atopic Dermatitis With Moderate to Severe Itching","Evaluation of the Safety and Efficacy of Upadacitinib in the Treatment of Atopic Dermatitis With Moderate to Severe Itching and Refractory Autoimmune Related Cholangitis: a Single Arm, Exploratory Clinical Study","Inclusion Criteria\n\nPatients must meet all of the following criteria to be eligible for enrollment:\n\n1. Aged ≥18 and ≤70 years, of either sex.\n2. Criteria for Atopic Dermatitis (AD)\n\n   Diagnosis of AD according to the Chinese diagnostic criteria for adult AD, defined as meeting the primary criterion (a) plus either criterion (b) or (c) below:\n   1. Presence of symmetrical eczema with a disease duration of more than 6 months.\n   2. Personal and\u002For first-degree family history of atopic diseases (e.g., eczema, allergic rhinitis, asthma, allergic conjunctivitis, etc.).\n   3. At least one of the following laboratory findings: elevated serum total immunoglobulin E (IgE), elevated peripheral blood eosinophil count, or positive allergen-specific IgE.\n\n   Presence of moderate-to-severe pruritus, defined as a Visual Analogue Scale (VAS) score ≥4.\n3. Criteria for Primary Biliary Cholangitis (PBC)\n\n   Diagnosis of PBC according to practice guideline criteria, defined as meeting at least two of the following three criteria:\n   1. Biochemical evidence of cholestasis, primarily elevated alkaline phosphatase (ALP) and\u002For gamma-glutamyl transferase (GGT).\n   2. Positivity for anti-mitochondrial antibody (AMA) or AMA-M2, or positivity for other disease-specific autoantibodies (anti-gp210 or anti-sp100 antibodies).\n   3. Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction.\n\n   Patients must have received a standard regimen of ursodeoxycholic acid (UDCA) for ≥12 months (at a dose of no less than 13-15 mg\u002Fkg\u002Fday) in combination with at least two subsequent-line therapies (including Farnesoid X receptor agonists, peroxisome proliferator-activated receptor agonists, budesonide, or other immunosuppressants) for ≥3 months.\n\n   At screening, ALP ≥1.5 × upper limit of normal (ULN) or GGT ≥5 × ULN.\n4. Criteria for Primary Sclerosing Cholangitis (PSC)\n\nFor large-duct PSC, diagnosis must meet the following criteria:\n\n1. Biliary imaging showing characteristic multifocal, short-segmental, or annular strictures involving both intra- and extrahepatic bile ducts.\n2. At least one of the following clinical manifestations: biochemical evidence of cholestasis (primarily elevated ALP and\u002For GGT); clinical or histological evidence of coexisting inflammatory bowel disease (IBD); or liver histology showing periductal inflammation with fibrosis (i.e., periductal \"onion-skin\" appearance).\n3. Exclusion of secondary sclerosing cholangitis due to other etiologies.\n\nFor small-duct PSC, diagnosis must meet the following criteria:\n\n1. Biochemical evidence of cholestasis with no significant abnormalities on recent biliary imaging.\n2. Liver histology showing typical PSC changes as described above (periductal inflammation with fibrosis \u002F \"onion-skin\" appearance).\n3. Exclusion of other causes of cholestasis. Patients must have received a standard regimen of UDCA for ≥3 months (at a dose of no less than 13-15 mg\u002Fkg\u002Fday). At screening, ALP ≥1.5 × ULN or GGT ≥5 × ULN.\n\nExclusion Criteria\n\nPatients who meet any of the following criteria will be excluded from enrollment:\n\n1. Known concurrent or history of other hepatobiliary diseases, including but not limited to: active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; complete biliary obstruction; acute cholecystitis or symptomatic cholelithiasis; suspected or confirmed hepatocellular carcinoma (HCC) or cholangiocarcinoma.\n2. Child-Pugh Class C cirrhosis; evidence of end-stage liver disease, including: history of liver transplantation or being on the liver transplant waiting list; Model for End-Stage Liver Disease (MELD) score \\>20; severe portal hypertension complications (including severe gastric or esophageal varices, refractory or diuretic-resistant ascites, history of variceal bleeding); or other serious cirrhosis-related complications (spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome).\n3. Total bilirubin \\>10 × upper limit of normal (ULN).\n4. Serum creatinine ≥1.5 × ULN and creatinine clearance \\\u003C60 mL\u002Fmin.\n5. Platelet count \\\u003C50 × 10⁹\u002FL.\n6. International normalized ratio (INR) \\>1.5.\n7. Serum albumin \\\u003C3.0 g\u002FdL.\n8. Use of moderate or strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 14 days prior to the first dose of study drug or planned use throughout the study period.\n9. Presence of diseases that may cause non-hepatic elevation of ALP (e.g., Paget's disease of bone) or any condition with an anticipated life expectancy of less than 2 years.\n10. Known drug abuse or alcohol abuse within 6 months prior to the first dose of study drug, defined as weekly alcohol consumption exceeding 14 standard drinks (1 standard drink equivalent to 360 mL beer, 45 mL of 40% distilled spirits, or 150 mL wine).\n11. Unstable concomitant diseases or use of concomitant medications that cannot be maintained on a stable regimen throughout the clinical study period.\n12. Pregnant women, women planning to become pregnant, breastfeeding women, or fertile patients (male or female) who are unwilling to use at least one effective method of contraception from the time of signing informed consent until 30 days after the last dose of study drug.\n13. Participation in any other interventional clinical trial and receipt of any investigational product within 3 months prior to the first dose of study drug.\n14. Positive results for human immunodeficiency virus antibodies (HIV Ab) or Treponema pallidum antibodies (TP Ab).\n15. Any other condition that, in the investigator's judgment, would preclude the patient's participation in this study.","ALL","18 Years","70 Years",{"count":20,"type":21},44,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Cholestatic liver diseases are characterized by jaundice, pruritus, and elevated levels of alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT). Primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC) represent the major autoimmune-driven entities within this category. Without effective intervention, these conditions may progress to liver failure and even death. Ursodeoxycholic acid (UDCA), the first-line therapy for PBC, has been shown to improve prognosis; however, 20%-40% of patients exhibit an inadequate biochemical response. For PSC, no clearly effective pharmacologic agent is currently available. In refractory patients, pruritus often progressively worsens, severely impairing quality of life and treatment adherence, underscoring an urgent need for novel therapeutic approaches that simultaneously address disease control and itch relief.\n\nAutoimmune-associated cholangitis frequently coexists with atopic dermatitis, and in a subset of patients, pruritus may be compounded by dermatologic factors. The pruritus of atopic dermatitis involves the JAK-STAT signaling pathway, which not only serves as a convergent node for pruritic signals but also constitutes a key downstream hub in the immune dysregulation characteristic of cholangitis. Inhibition of this pathway is therefore hypothesized to alleviate pruritus and modulate aberrant immune responses. Case reports have suggested that upadacitinib, a selective JAK inhibitor, may improve biochemical parameters in refractory PBC and exhibit potential anti-fibrotic effects.\n\nTo this end, investigators plan to conduct an exploratory clinical study to systematically evaluate the safety and efficacy of upadacitinib in patients with atopic dermatitis complicated by moderate-to-severe pruritus and refractory autoimmune-associated cholangitis.",[27,28,29],"Primary Biliary Cholangitis (PBC)","Primary Sclerosing Cholangitis (PSC)","Atopic Dermatitis (AD)",[27,28,29,31,32,33,34,35,36,37,38,39],"pruritus","upadacitinib","cholangitis","bile duct diseases","biliary tract diseases","Digestive System Diseases","Cirrhosis, Biliary","Cholangitis, Biliary","Cholangitis, Sclerosing","NOT_YET_RECRUITING","2026-06-30",{"date":43,"type":44},"2026-07-01","ACTUAL",{"date":46,"type":21},"2026-06-01",{"date":48,"type":21},"2028-05-31",{"name":50,"class":51},"RenJi Hospital","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":16,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":52},"100642387","phase-2-vancomycin-efficacy-in-response-to-dysbiosis-in-atypical-colitis-100642387","NCT07646223","Vancomycin Efficacy in Response to Dysbiosis in Atypical Colitis","The Efficacy of Oral Vancomycin Therapy in Managing Different Phenotypes of Paediatric Inflammatory Bowel Diseases by Correlating Treatment Response to Commensal Microbiota Composition and Function","VERDA","Inclusion criteria.\n\n* children aged 6-15 years\n* able to swallow capsules\n* are scheduled for diagnostic endoscopy at Tampere University\n* has not received oral vancomycin before\n* do not have active infection (such as clostridium or other bacteria)\n* has not received new interventions (medications or new conventional therapies) for treating IBD was given within the past 4 weeks before starting OVT.\n\nExclusion Criteria:\n\n* The presence of PSC without UC, Crohn's disease type of inflammatory bowel diseases.\n* Under the age of 6 years old.\n* Is unable to swallow capsules.\n* Had a previous allergic reaction to vancomycin (such as vancomycin allergy) and\u002For other related antibiotics similar to vancomycin.\n* Presence of malignant disease or potential need for liver transplantation within the following 12 months.\n* Pregnancy\n* Known renal insufficiency or chronic renal disease","6 Years","15 Years",{"count":64,"type":21},140,[24],"The goal of this clinical trial is to learn how oral vancomycin therapy may contribute in treating paediatric inflammatory bowel disease, particularly atypical ulcerative colitis and PSC-associated colitis. It will also give more information on how this treatment affects gut microbiota and metabolism.\n\nThe main questions it aims to answer are:\n\n1. Does oral vancomycin improve disease activity and lead to remission (based on symptoms, biomarkers, and endoscopy findings)?\n2. How does oral vancomycin change gut metabolism?\n3. Does different types of colitis respond differently to oral vancomycin?\n\nResearchers will compare children receiving oral vancomycin plus standard therapy to those receiving standard therapy alone. The gut metabolisim before and after oral vancmycin will also be compared, as well as to healthy controls and children with typical ulcerative colitis.\n\nParticipants will:\n\n1. Take oral vancomycin (if assigned) together with conventional treatment for at least 3 months and up to 12 months depending on response\n2. Visit the clinic approximately every 3 months for checkups, tests, and monitoring\n3. Provide blood, stool, and saliva samples to study disease activity and microbiota activity\n4. Undergo clinical assessments such as symptom scoring, imaging, and possibly endoscopy\n5. Complete questionnaires about quality of life\n6. Be monitored for side effects and treatment response throughout the study period",[68,28,69],"Ulcerative Colitis (UC)","Pediatric Inflammatory Bowel Diseases",[71,72,73,74,75],"PSC-UC","atypical UC","oral vancomycin","colitis","PIBD","2026-06-09",{"date":78,"type":44},"2026-06-12",{"date":80,"type":21},"2026-08-01",{"date":82,"type":21},"2035-12-31",{"name":84,"class":51},"Tampere University Hospital",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":97,"conditions":98,"keywords":99,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":52},"100639188","biodegradable-stents-in-primary-sclerosing-cholangitis-100639188","NCT07607353","Biodegradable Stents in Primary Sclerosing Cholangitis","Pilot Study of Biodegradable STents in Primary Sclerosing Cholangitis - BSTPSC","BSTPSC","Inclusion Criteria:\n\n* PSC patients with a high grade stricture\n\nExclusion Criteria:\n\n* Prior stenting or balloon dilatation within the previous 4 months\n* Signs of bacterial cholangitis as defined by definite cholangitis\n* Change of UDCA therapy within 4 weeks\n* Inability to give informed consent\n* Biliary cirrhosis with Child Pugh score \\> 8\n* Estimated transplant free survival \\\u003C 2 years as calculated by Mayo score \\> 2\n* Suspicion of cholangiocarcinoma, reflected by an imaging study suggestive of metastasis, MRCP with mass lesion with contrast enhancenment, or rise in CA19.9 of \\> 63 U\u002Fml in the previous 4 months together with an absolute value \\> 130 U\u002Fml\n* Signs of current malignancy other than basal cell carcinoma\n* Life expectancy \\\u003C 24 months\n* Women pregnant at the time of screening\n* HIV or acute or chronic hepatitis B or hepatitis C or substance (drug or alcohol) misure within the previous 2 years.",{"count":94,"type":21},20,[96],"NA","In patients with PSC, endoscopic therapy of strictures aims to improve cholestasis by relieving the biliary obstruction via endoscopic biliary dilatation with consideration of plastic stents in strictures refractory to dilatation due to the risk of pancreatitis and cholangitis . Short term stents have been shown to have similar recurrence-free rates compared to dilatation in a randomised control trial; however, this was terminated after interim analysis due to higher rates of serious adverse events in the stent group. The long term benefits are unclear; however, it may lead to improved survival compared to predicted survival. In this group of patients with limited treatment options, biodegradable stents may provide an attractive additional treatment modality in the management of high grade strictures.",[28],[100,101,102],"PSC","ERCP","Biodegradable stents","RECRUITING","2026-05-27",{"date":106,"type":44},"2026-05-29",{"date":108,"type":44},"2026-03-01",{"date":110,"type":21},"2027-04-01",{"name":112,"class":51},"King's College Hospital NHS Trust",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":22,"phases":123,"briefSummary":124,"conditions":125,"keywords":127,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":52},"100629677","phase-2-fecal-microbiota-transplantation-for-primary-sclerosing-cholangitis---randomized-study-versus-sham-transplantation-100629677","NCT07477782","Fecal Microbiota Transplantation for Primary Sclerosing Cholangitis - Randomized Study Versus Sham Transplantation","FMT-SCLER","Inclusion Criteria:\n\n* Males or females\n* Age ≥18 and ≤75 years\n* Large duct PSC verified by retrograde, operative, percutaneous or magnetic resonance cholangiography (MRC) demonstrating intrahepatic and \u002For extrahepatic biliary duct changes consistent with PSC\n* IBD diagnosed according to international guidelines (presence of endoscopic and histologic signs)\n* IBD inactive for at least 6 months (defined by no evidence of flare and no change in treatment)\n* ALP ≥ 1.3 ULN (at least 2 times within a 3 months pre-inclusion period) or elevated total bilirubin ≤50 umol\u002Fl (with concomitant elevated direct bilirubin).\n* Treatment with UDCA (13-23 mg\u002Fkg\u002Fd) for at least 6 months and at the same dosage for at least 3 months\n* Using contraceptive in women of childbearing potential and agrees to pursue it from inclusion until week 48. Women of childbearing potential, i.e. fertile, following menarche and until becoming post-menopaused unless permanently sterile, who are sexually active have to apply a highly effective method of birth control with a low failure rate (i.e. less than 1% per year) when used constantly and correctly.\n* Written informed consent signed\n* Subject affiliated to the French\n* Social Security System\n\nExclusion Criteria:\n\n* Small duct PSC\n* Autoimmune hepatitis defined by the presence of moderate to severe interface hepatitis documented on liver biopsy and at least 1 of the 2 following criteria: AST or ALT \\> 5 ULN, Positive anti smooth muscle auto antibodies or serum IgG \\> 1.5 ULN\n* Secondary sclerosing cholangitis (notably IgG4-associated cholangitis)\n* Cirrhosis defined by Liver elastometry \\>14.4 kPa or by current or past decompensation of cirrhosis\n* AST or ALT \\> 7 ULN in the last 3 months\n* Platelets count in the last 3 months \\\u003C 100 000\u002Fmm3\n* Albumin in the last 3 months \\\u003C35g\u002FL\n* Prothrombin index in the last 3 months \\\u003C 70%\n* Hepatic comorbidity: HBV infection (defined by positive Ag HBS), HCV infection (defined by positive HCV RNA), alcohol abuse (defined by alcohol intake \\> 30g\u002Fday), metabolic dysfunction associated steatohepatitis, primary biliary cholangitis, Hemochromatosis, Wilson disease, α1-antitrypsin deficiency, celiac disease\n* History of acute cholangitis in the last 3 months prior to inclusion or current acute cholangitis\n* HIV infection\n* Prior liver transplantation\n* Endoscopic treatment for bile duct stenosis ≤ 3 months prior to inclusion or planned within 3 months post randomization date\n* History of or established or suspected hepatobiliary carcinoma.\n* Any severe comorbidity that may reduce life expectancy\n* History of malignancy diagnosed or treated within 2 years (recent localized treatment of squamous or non-invasive basal skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to inclusion)\n* Dosage changes of treatment for liver disease in the last 3 months or new treatment for liver disease started in the last 3 months\n* History of colorectal carcinoma or high-grade dypsplasia in previous screening colonoscopy\n* History of total colectomy\n* Current active IBD defined by a partial Mayo score \\> 2 in patients with ulcerative colitis (UC), unclassed colitis or a Crohn's Disease Activity Index (CDAI) \\> 150 in patients with Crohn's disease\n* Changes in IBD treatment or initiation of a new treatment for IBD in the last 3 months\n* Current treatment with biologics (anti-TNF agent, vedolizumab, ustekinumab) or JAK inhibitors (tofacitinnib) or prednisone \\> 10 mg\u002Fday or budesonide \\> 3 mg \u002Fday) (or treatment initiated less than one month)\n* Any contra-indication to swallow capsules\n* Renal insufficiency (clearance\\\u003C60 ml\u002Fmin)\n* Unable to consent, subject to legal or administrative decision (protection measure or deprivation of liberty) or involuntary psychiatric care.\n* Participation in another interventional research without prior consultation with the investigator responsible for the patient's monitoring in the present study (participation in other non-interventional studies is permitted)\n* Pregnancy or desire for pregnancy or breastfeeding\n\nRandomization criteria\n\n* No pregnancy (or desire for in the next year)\n* No other hepatic pathology: HBV (positive HBs Ag), HCV (positive HCV antibody and positive PCR), autoimmune hepatitis\n* No HIV infection (positive serology HIV1+2 antibodies)\n* No documented Clostridium difficile infection at inclusion or \\\u003C 10 days preceding randomization (in case of infection discovered at inclusion)\n* No treatment with antibiotics, antifungics or probiotics \\\u003C 4 weeks.\n* Available FMT with EBV and CMV compatibility","75 Years",{"count":122,"type":21},72,[24],"Primary Sclerosing Cholangitis (PSC) is a rare cholestatic liver disease, commonly associated with inflammatory bowel disease (IBD) The aim of the present trial is to assess the efficacy of fecal microbiota transplantation (FMT) on ALP and bilirubin compared to sham transplantation in addition to ursodeoxycholic acid (UDCA) treatment in PSC patients.",[28,126],"Inflammatory Bowel Disease (IBD)",[128,129,130,131,132,133],"Primary Sclerosing Cholangitis","inflammatory bowel disease","fecal microbiota transplantation","ursodeoxycholic acid","alkaline phosphatase","bilirubin","2026-03-12",{"date":136,"type":44},"2026-03-17",{"date":138,"type":21},"2026-05",{"date":140,"type":21},"2030-05",{"name":142,"class":51},"Assistance Publique - Hôpitaux de Paris",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":22,"phases":152,"briefSummary":153,"conditions":154,"keywords":155,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":52},"100619181","phase-2-investigation-of-vancomycin-efficacy-in-patients-with-ulcerative-colitis-and-primary-sclerosing-cholangitis-100619181","NCT07341282","Investigation of Vancomycin Efficacy in Patients With Ulcerative Colitis and Primary Sclerosing Cholangitis","DRIVE-UP","Inclusion Criteria\n\n* Adults aged ≥18 years.\n* Confirmed diagnosis of UC and PSC.\n* Moderate to severe UC disease activity (total Mayo score ≥5; endoscopic subscore ≥2).\n* Informed consent provided. Exclusion Criteria\n* Diagnosis of Crohn's disease or indeterminate colitis.\n* Fulminant colitis or need for immediate surgical intervention.\n* Use of antibiotics or probiotics within the past 4 weeks (for microbiome substudy).\n* Decompensated liver disease (Child-Pugh B\u002FC).\n* Severe Renal Impairment (CrCl \\\u003C30mL\u002Fmin)\n* Active untreated infection.\n* Pregnancy or lactation.\n* Prior allergy or intolerance to Vancomycin\n* History of hearing loss or current hearing problems",{"count":151,"type":21},14,[24],"This clinical trial tests if oral vancomycin can safely treat active ulcerative colitis (UC) in adults who also have primary sclerosing cholangitis (PSC), a liver condition. The main questions it aims to answer are:\n\n* Can oral vancomycin improve UC symptoms as measured by Mayo score at 4 weeks?\n* Is oral vancomycin safe and tolerable in this patient group?\n\nParticipants will be compared to see if vancomycin works better than placebo. Participants will:\n\n* Take oral vancomycin (250 mg twice daily) or identical placebo capsules for 4 weeks\n* Have the option for 4 more weeks of open-label vancomycin after the blinded phase\n* Attend clinic visits at baseline, week 4, and follow-up for Mayo scoring, endoscopy, blood\u002Fstool tests, and safety checks\n* Track treatment adherence and side effects\n\nThe study primarily assesses if the trial can recruit 14 participants, retain them, achieve good adherence, and follow protocol procedures (feasibility). Secondary goals include safety (adverse events) and early signs of benefit in UC activity, liver tests, and gut bacteria balance. This pilot will guide larger future studies.",[68,28],[156,128,157,158],"Ulcerative Colitis","Vancomycin","Randomized Control Trial","2026-01-05",{"date":161,"type":44},"2026-01-14",{"date":163,"type":21},"2026-01",{"date":165,"type":21},"2027-03",{"name":167,"class":51},"McMaster University",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":120,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":180,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":196},"100569813","phase-2-a-study-to-assess-the-safety-and-efficacy-of-lb-p8-in-patients-with-psc-100569813","NCT06699121","A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC","A Phase 2 Randomized, Double Blind, Placebo Controlled, Parallel Study Evaluating the Safety and Efficacy of LB P8 in Patients With Primary Sclerosing Cholangitis (PSC)","Inclusion Criteria:\n\n* Age: 18 to 75 years\n* A diagnosis of PSC based on cholangiographic evidence of PSC in accordance with American Association for the Study of Liver Diseases (AASLD) guidelines\n* ALP \\>1.5 times the ULN at screening\n* PSC with or without IBD, such as ulcerative colitis or Crohn's disease\n* If patients are being administered biologic or advanced therapeutic treatments, immunosuppressants, systemic corticosteroids, obeticholic acid, fibrates, or statins, they must be on a stable dose for ≥3 months prior to, and including, Day 0 and plan to remain on a stable dose throughout the study\n* If patients are receiving ursodeoxycholic acid, they must be on a stable dose (not exceeding 23 mg\u002Fkg\u002Fday) for \\>3 months prior to screening\n* Patient agrees to stop all probiotics for at least 2weeks prior to treatment\n* Patient is unable to conceive and\u002For patient who's partner is unable to become pregnant and\u002For agree to use effective methods of contraception when engaging in heterosexual intercourse\n\nExclusion Criteria:\n\n* Treatment with any investigational agents within 3 months or 5 half-lives, whichever is longer prior to treatment or during the study. Gene therapy or other long-lasting investigational agents with unknown half-life is not allowed\n* History of a liver transplant or anticipated need for a liver transplant within 1 year\n* Patients who show evidence of significant worsening of hepatic function will be excluded.\n* Evidence of compensated or decompensated cirrhosis based on histology, relevant medical complications, or laboratory parameters\n* Model for end-stage liver disease (MELD) score as below, unless the MELD is driven by anticoagulant therapy, vitamin deficiency, or kidney disease:\n* MELD Score of \\>12 (decompensated cirrhosis) for Part 1 of the study\n* MELD Score of \\>12 for Part 2 of the study\n* Small-duct PSC (in the absence of large duct PSC)\n* Secondary causes of sclerosing cholangitis including IgG4 associated sclerosing cholangitis\n* Any history of cholangiocarcinoma, gallbladder cancer, or hepatocellular carcinoma\n* History of any malignancy with lymph node or regional metastases within 5 years or current malignancy undergoing active treatment\n* Patients who require chronic use of antibiotics, received antibiotics in the last 1 month, or received Rebyota or Vowst (applicable for patients with Clostridioides difficile infection)\n* In patients with ulcerative colitis, partial Mayo score of \\>6 or, patients with Crohn's disease if CDAI of \\>220\n* Chronic kidney injury\n* Recent acute cholangitis (within 90 days)\n* Patients with indwelling biliary drain (or stent), total proctocolectomy with ileal anal pouch, partial large bowel resections or history of small bowel resection\n* Other causes of liver disease, such as autoimmune hepatitis (AIH), primary biliary cholangitis (PBC), AIH\u002FPSC overlap syndrome, alpha-1-antitrypsin deficiency, viral hepatitis, iron overload syndrome, Wilson disease, nonalcoholic steatohepatitis, and\u002For alcohol related liver disease. Additionally, positive serology for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti HCV) (detectable HCV RNA in the serum), or human immunodeficiency virus antibodies (anti HIV)\n* Active drug (known or suspected use of illicit drugs or drugs of abuse) or alcohol abuse disorder\n* Female patients who are pregnant, nursing, or planning to become pregnant during the study\n* Clinically significant and\u002For active infection\n* Subjects with a greater degree of immunosuppression, as evidenced by Alsolute neutrophil count \\\u003C500 cells\u002FmL or in the investigator's judgement immunosuppressed and at higher risk of infection",{"count":176,"type":21},87,[24],"The study is designed to assess the safety and efficacy of LB-P8 in patients with primary sclerosing cholangitis.",[28],[100,181,182,183,184,185],"Pruritus","Inflammatory bowel disease","IBD","Itch","Cholestasis","2025-10-22",{"date":188,"type":44},"2025-10-24",{"date":190,"type":21},"2025-11",{"date":192,"type":21},"2029-02",{"name":194,"class":195},"LISCure Biosciences","INDUSTRY",7,{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":203,"targetDuration":205,"studyType":206,"phases":4,"briefSummary":207,"conditions":208,"keywords":209,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":211,"lastUpdatePostDateStruct":212,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":220},"100297049","swiss-primary-sclerosing-cholangitis-cohort-study-100297049","NCT03146936","Swiss Primary Sclerosing Cholangitis Cohort Study","Inclusion Criteria:\n\n* Patients diagnosed with PSC according to established criteria (European Association for the Study of the Liver. EASL Clinical Practice Guidelines: management of cholestatic liver diseases) of any age. Patients not fulfilling such criteria but still diagnosed with PSC in a hepatology referral centre can be included\n* patients living in Switzerland\n\nExclusion Criteria:\n\n* N\u002FA",{"count":204,"type":21},120,"5 Years","OBSERVATIONAL","Research project in which biological material is sampled and health-related personal data is further used and collected.\n\nCoded data are used.",[39,100,28],[100,128,210],"Cohort","2025-08-14",{"date":213,"type":44},"2025-08-19",{"date":215,"type":44},"2017-02-28",{"date":217,"type":21},"2030-12-31",{"name":219,"class":51},"Fondazione Epatocentro Ticino",21,{"id":222,"slug":223,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":22,"phases":230,"briefSummary":231,"conditions":232,"keywords":233,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":4},"100591032","phase-2-efficacy-and-safety-of-hk-660s-in-the-treatment-of-primary-sclerosing-cholangitis-100591032","NCT06975150","Efficacy and Safety of HK-660S in the Treatment of Primary Sclerosing Cholangitis","A Randomized, Double-blind, Placebo-controlled, Parallel Group, 12 Weeks, Phase 2b Clinical Study to Evaluate the Efficacy and Safety of HK-660S in Patients With Primary Sclerosing Cholangitis (PSC)","Inclusion Criteria:\n\n1. Male or female subjects aged ≥ 18 years.\n\n   * Subjects and their sexual partner(s) who do not plan to become pregnant and agree to use at least one effective, appropriate contraceptive method (defined below) during the study period and up to 30 days after the last dosing of study drug\n   * Contraception method: 1) hormonal contraceptives, 2) intrauterine contraceptive device or implantation of intrauterine system, 3) double-barrier method (combined use of spermicides and condoms, diaphragm, contraceptive sponge, or FemCap), or 4) sterilization (e.g., vasectomy, tubal ligation)\n   * Women who are post-menopausal (have amenorrhea for 12 months or over 6 weeks after bilateral oophorectomy) and unlikely to become pregnant\n2. Subjects who have a diagnosis of PSC:\n\n   * Serum alkaline phosphatase (ALP) of \\> 2.0 x upper limit of normal (ULN) at screening\n   * Subjects who have sclerosing cholangitis due to multifocal bile duct in magnetic resonance cholangiopancreatography (MRCP) or endoscopic retrograde cholangiopancreatography (ERCP) within 6 months from screening\n3. Subjects who are able to understand information provided directly or via his\u002Fher representative and to give voluntary, written consent to participate in the study.\n\nExclusion Criteria:\n\n1. Subjects with an average alcohol intake of more than 20g per day within 2 years prior to screening.\n2. Subjects who have a diagnosis of type 1 diabetes or uncontrolled type 2 diabetes (HbA1c ≥ 9%) prior to screening.\n3. Subjects who have chronic liver diseases other than PSC: non-alcoholic fatty liver disease, viral chronic hepatitis, alcoholic liver disease, primary biliary liver cholangitis, biliary obstruction, autoimmune hepatitis, hemoglobin deposition, Wilson's disease, α-1 antitrypsin deficiency, etc.\n4. Subjects who have a diagnosis of primary biliary cholangitis or secondary sclerosing cholangitis in MRCP or ERCP prior to screening.\n5. Subjects who have obstacles to MRCP implementation (e.g., cardiac pacemakers, clipped cerebral aneurysms, metallic foreign objects in the eyeball, claustrophobia).\n6. Subjects who have ALT or AST \\> 5 x ULN.\n7. Subjects who have serum creatinine ≥ 2 mg\u002Fdl.\n8. Subjects who are deemed unsuitable for participation in the study at Screening, at the discretion of the investigator, due to the following: cirrhosis, severe metabolic disease, severe renal failure, severe lung disease, severe neuro\u002Fpsychiatric disease, muscle disease, etc.\n9. Subjects who have any clinically significant cardiovascular diseases.\n10. Subjects who have uncontrolled thyroid diseases including hyperthyroidism and hypothyroidism. However, subjects who have been stably managed with thyroid disease treatment for at least 6 months prior to Screening may be included at the discretion of the investigator.\n11. Subjects who have a history of immune diseases: autoimmune thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, severe psoriasis, rheumatoid arthritis, etc. However, at the discretion of the investigator, patients with atopic dermatitis that is mild or can be stably managed with topical atopic dermatitis treatment may be included.\n12. Subjects who had bariatric surgery within 6 months prior to screening.\n13. Subjects who have undergone or are planned for liver transplantation or with current model of end stage liver disease (MELD).\n14. Subjects who have positive results at the Screening visit for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).\n15. Subjects who have a history of chronic infections or have severe or life-threatening infections, or symptoms that may be considered related to infections (e.g., fever, cough). However, subjects with mild-to-moderate inflammatory bowel diseases (e.g., ulcerative colitis, Crohn's disease) who can be stably managed with 5-aminosalicylic acid, azathioprine or topical steroids may be included at the discretion of the investigator. Subjects on biologics (e.g. infliximab, adalimumab, vedolizumab, ustekinumab) or JAK inhibitors (e.g. tofacitinib) for IBD treatment are allowed if the dose has been stable for at least 12 weeks before Screening and is expected to remain stable throughout the study.\n16. Subjects with evidence of an active infection during the screening period.\n17. Subjects diagnosed with a malignant tumor without complete cure within 5 years prior to screening.\n18. Subjects whose medication history includes any of the following drugs, within a period of 5 times the half-life of the respective drug prior to screening:\n\n    * Therapeutics agents for steatohepatitis: thiazolidinediones, high-dose vitamin E (800 IU\u002Fday), pentoxifylline\n    * Medications possibly related to PSC: high-dose ursodeoxycholic acid (UDCA; doses smaller than 28 mg\u002Fkg\u002Fday may be permitted if administered stably without change in dosage from 3 months prior to screening), immunosuppressants, obeticholic acid (OCA), budesonide, docosahexaenoic acid, methotrexate, metronidazole, minocycline, mycophenolate mofetil, nicotine, pentoxifylline, pirfenidone, prednisolone, systemic glucocorticoids, tacrolimus (If a patient is on any of the following medications and\u002For supplements, he or she can participate only expected to remain on the same daily dose through the treatment period: UDCA, vancomycin, azathioprine, prednisone \\[or an equivalent steroid compound\\]).\n19. Subjects who administered herbal medicine or folk remedies to improve fatty liver disease within 2 weeks prior screening.\n20. Subjects who have a history of alcohol or drug abuse within 5 years prior to screening.\n21. Subjects who have a hypersensitivity to any excipients of the study drug.\n22. Subjects who participated in another drug trial within 30 days prior to screening.\n23. Subjects who are considered inappropriate to participate in clinical trials at the discretion of the investigator.",{"count":229,"type":21},105,[24],"The cause of PSC is unknown.To date, there is no treatment besides liver transplantation proven to improve PSC prognosis. However, there is a clear medical unmet need yet for patients with PSC, due to risks and complications of liver transplantation.\n\nThis is a two-part, Phase 2b, randomized, double-blind, placebo-controlled study designed to assess the efficacy and safety of HK-660S in patients with PSC.\n\nThe primary objective is to evaluate the effects of HK-660S on serum ALP improvement (reduction of 20% or more) over 12 weeks of treatment in patients with PSC.",[28],[234,100,128,235],"HK-660S-202","HK-660S","2025-05-08",{"date":238,"type":44},"2025-05-16",{"date":240,"type":21},"2025-08-18",{"date":242,"type":21},"2028-08-30",{"name":244,"class":195},"CuromeBiosciences",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":253,"targetDuration":255,"studyType":206,"phases":4,"briefSummary":256,"conditions":257,"keywords":260,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":52},"100575078","spanish-registry-of-autoimmune-and-cholestatic-liver-diseases-colhai-100575078","NCT06767605","Spanish Registry of Autoimmune and Cholestatic Liver Diseases (ColHai)","Registro Español de Enfermedades Hepáticas Colestásicas y Autoinmunes (ColHai)","ColHai","Inclusion Criteria:\n\n* Patients with a confirmed diagnosis for PBC, HAI, PSC, genetic cholestatic disease\n\nExclusion Criteria:\n\n* Refusal to sign the informed consent for the study",{"count":254,"type":21},5000,"35 Years","The purpose of the registry is to know the status of primary biliary colgantis, autoimmune hepatitis, primary sclerosing cholagitis and genetic cholestatic diseases in Spain.",[258,27,28,259],"Hepatitis Autoimmune Disease","Cholestatic Genetic Diseases",[259,28,258,27,261,262,263,264,265,266,267,268,269,270,271,272],"PFIC tipo 1","PFIC tipo 2","PFIC tipo 3","PFIC tipo 4","BRIC tipo 1","BRIC tipo 2","Alagille syndrome","Rotor syndrome","Dubin Johnson syndrome","Genetic disease","Registry","cholestatic diseases","2025-01-06",{"date":275,"type":44},"2025-01-10",{"date":277,"type":44},"2016-01-01",{"date":279,"type":21},"2030-12",{"name":281,"class":51},"Asociación Española para el Estudio del Hígado"]