[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-biliary-cholangitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-biliary-cholangitis":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,38,67,93,122,147,173,202,225,248,267,289,310,332,352,377,397,428,454,479],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100550445","a-study-observing-everyday-effectiveness-and-safety-of-the-drug-elafibranor-in-participants-with-primary-biliary-cholangitis-who-are-receiving-ongoing-treatment-100550445",false,"NCT06447168","A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment","Prospective Non-interventional, Phase IV Multicentre Study to Assess the Effectiveness, Safety and Tolerability of Elafibranor 80 mg\u002FDay in Participants With Primary Biliary Cholangitis Receiving Treatment in a Real-world Setting.","ELFINITY","Inclusion Criteria:\n\n* Participant has provided written informed consent and agrees to comply with the study protocol.\n* Participant with PBC diagnosis.\n* Participant for whom the treating physician has decided to start or participants who are currently receiving treatment with commercialized elafibranor.\n* If a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected.\n\nExclusion Criteria:\n\n* Participant is currently participating or, plans to participate in an investigational drug study or medical device study containing active substance.\n* Participant with known hypersensitivity to the product or to any of its excipients.\n* Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.","ALL",{"count":19,"type":20},424,"ESTIMATED","OBSERVATIONAL","This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting.\n\nPBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged.\n\nThe liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms including pruritus (itching) and fatigue. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.\n\nIn this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 60 months (approximately 5 years).",[24],"Primary Biliary Cholangitis","RECRUITING","2026-07-01",{"date":28,"type":29},"2026-07-02","ACTUAL",{"date":31,"type":29},"2024-10-14",{"date":33,"type":20},"2032-07-15",{"name":35,"class":36},"Ipsen","INDUSTRY",68,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":66},"100520058","phase-3-seladelpar-in-subjects-with-primary-biliary-cholangitis-pbc-and-compensated-cirrhosis-100520058","NCT06051617","Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis","AFFIRM: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis","AFFIRM","Inclusion Criteria:\n\nIndividuals must meet the following criteria to be eligible for study participation:\n\n1. Must be at least 18 years old.\n2. Must have a confirmed prior diagnosis of PBC\n3. Evidence of cirrhosis\n4. CP Score A or B\n5. Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male individuals who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose\n6. Individuals must be able to comply with the instructions for study drug administration and be able to complete the study schedule of assessments (SOA)\n\nExclusion Criteria:\n\nIndividuals must not meet any of the following criteria to be eligible for study participation:\n\n1. Prior exposure to seladelpar\n2. A medical condition other than PBC that, in the Investigator's opinion, would preclude full participation in the study\n3. History of liver transplantation or actively listed for cadaveric or planned living donor transplant.\n4. Decompensated cirrhosis\n5. Evidence of portal vein thrombosis based on imaging at time of Screening by Doppler ultrasound or prior evidence by CT or MRI\n6. Hospitalization for liver-related complication within 12 weeks of Screening\n7. Laboratory parameters at Screening:\n\n   1. Alkaline phosphatase (ALP) \\\u003C 1.5× Upper limit of normal (ULN) or ≥ 10×ULN\n   2. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥5×ULN\n   3. Total bilirubin (TB) ≤ 0.6 × ULN or ≥ 5 × ULN\n   4. Platelet count ≤50×10\\^3\u002FµL\n   5. Albumin ≤2.8 g\u002FdL\n   6. Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73 m\\^2\n   7. MELD score \\>12. For individuals on anticoagulation medication, baseline International normalized ratio (INR) determination for MELD score calculation should take anticoagulant use into account, in consultation with the Medical Monitor.\n   8. Serum alpha-fetoprotein (AFP) \\>20 ng\u002FmL\n   9. INR \\>1.7\n8. CP-C cirrhosis\n9. History or presence of other concomitant liver diseases","18 Years",{"count":48,"type":20},318,"INTERVENTIONAL",[51],"PHASE3","To Evaluate the Effect of Seladelpar on Clinical Outcomes in Patients with Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis.",[24],[55,56],"Primary Biliary Cholangitis (PBC)","PBC","2026-06-19",{"date":59,"type":29},"2026-06-23",{"date":61,"type":29},"2023-09-07",{"date":63,"type":20},"2030-08",{"name":65,"class":36},"Gilead Sciences",203,{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":4,"enrollmentInfo":75,"targetDuration":77,"studyType":21,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100640745","austrian-pbc-registry-100640745","NCT07598669","Austrian PBC Registry","Characterisation of Patients With Primary Biliary Cholangitis in Austria - A Prospective Registry and Biobank","PBC-AUT","Inclusion Criteria:\n\n* Age \\>18 years\n* Confirmed diagnosis of primary biliary cholangitis (at least two of the following three criteria must be fulfilled: persistent elevation of alkaline phosphatase above the upper limit of normal for at least 6 months; presence of antimitochondrial antibodies or PBC-specific antinuclear antibodies; characteristic histopathology)\n* Written informed consent for participation in the registry\n\nExclusion Criteria:\n\n* Withdrawal of written informed consent",{"count":76,"type":20},500,"10 Years","The goal of this registry is to better understand how primary biliary cholangitis develops over time, including the role of disease-related biomarkers, complications of the disease, and symptom burden. Patients with primary biliary cholangitis treated at participating centres in Austria will be invited to take part in this prospective registry. Participation in an associated biobank is optional. Clinical and laboratory data will be collected, and patients will be followed regularly through scheduled clinic visits. In addition, biological samples (serum, plasma, and, if available, liver tissue) may be collected and stored in the biobank for future research.",[24,80,81],"Liver Cirrhosis","Portal Hypertension","2026-05-16",{"date":84,"type":29},"2026-05-20",{"date":86,"type":29},"2026-03-18",{"date":88,"type":20},"2040-12",{"name":90,"class":91},"Medical University of Vienna","OTHER",11,{"id":94,"slug":95,"hasResults":11,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":49,"phases":103,"briefSummary":105,"conditions":106,"keywords":107,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":121},"100443111","phase-2-a-study-to-evaluate-efficacy-and-safety-of-an-investigational-drug-named-volixibat-in-patients-with-itching-caused-by-primary-biliary-cholangitis-100443111","NCT05050136","A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Biliary Cholangitis","VANTAGE","Inclusion Criteria:\n\n* Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study\n* Male or female, age ≥18 years at the screening visit\n* Confirmed diagnosis of PBC in line with the AASLD guidelines\n* UDCA, anti-pruritic medication and PPAR agonist use will be allowed if meeting additional criteria\n* Qualified pruritus associated with PBC as assessed by Adult ItchRO\n\nExclusion Criteria:\n\n* Pruritus associated with an etiology other than PBC\n* Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events\n* Current symptomatic cholelithiasis or inflammatory gallbladder disease\n* History of small bowel surgery\u002Fresection impacting the terminal ileum that may disrupt the enterohepatic circulation.\n* Evidence, history, or suspicion of other liver diseases; PBC patients with AIH are not excluded\n* History of Liver transplantation",{"count":102,"type":20},260,[104],"PHASE2","The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.",[24,56],[108,56,109,110,24,111],"Pruritus","Itching","Cholangitis","Hepatobiliary disorders","2026-05-12",{"date":114,"type":29},"2026-05-14",{"date":116,"type":29},"2021-09-22",{"date":118,"type":20},"2027-07",{"name":120,"class":36},"Mirum Pharmaceuticals, Inc.",130,{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":49,"phases":133,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":4},"100625595","phase-3-study-of-saroglitazar-magnesium-for-pbc-patients-with-incomplete-response-or-intolerant-to-udca-therapy-100625595","NCT07424677","Study of Saroglitazar Magnesium for PBC Patients With Incomplete Response or Intolerant to UDCA Therapy","A Double-blind, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Saroglitazar Magnesium on Normalization of Alkaline Phosphatase Levels in Patients With Primary Biliary Cholangitis and an Incomplete Response or Intolerance to Ursodeoxycholic Acid","EPICS-IV","Inclusion Criteria:\n\n1. Adults between 18 and 80 years of age (both inclusive at screening)\n2. History of confirmed Primary Biliary Cholangitis diagnosis\n3. Ursodeoxycholic acid treatment for at least 12 months and a stable dose for at least 6 months prior to first screening visit OR intolerant to Ursodeoxycholic acid (last dose of Ursodeoxycholic acid at least 3 months prior to first screening visit).\n4. Average Alkaline Phosphatase at both screening Visits 1 and 2: \\> 1× Upper Limit of Normal and \\\u003C 1.67× Upper Limit of Normal, and \\\u003C 30% variance between both levels\n5. Total bilirubin ≤ 2 x Upper Limit of Normal at screening (Visit 1), unless there is a prior diagnosis of Gilbert's syndrome. For participants with Gilbert's syndrome, direct bilirubin is to be ≤ 2 x Upper Limit of Normal at screening (Visit 1).\n6. Must have given written informed consent (signed and dated).\n\nExclusion Criteria:\n\n1. Consumption of 14 or more standard alcohol drinks per week if male and 7 or more standard alcohol drink per week if female for at least 3 consecutive months (i.e., 12 consecutive weeks) within 5 years before screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits\u002Fhard liquor).\n2. History or presence of other concomitant liver diseases at screening\n3. Cirrhosis with complications, including history or presence of the following: spontaneous bacterial peritonitis, hepatocellular carcinoma, ascites requiring treatment, encephalopathy, known large esophageal varices, or history of variceal bleeding within one year prior to screening or history of hepatorenal syndrome.\n4. Medical conditions that may cause non-hepatic increases in Alkaline Phosphatase (e.g., Paget's disease) or which may diminish life expectancy to \\\u003C 2 years, including known cancers.\n5. Use of obeticholic acid, thiazolidinediones, fibrates (i.e. fenofibrate, bezafibrate, pemafibrate), other Peroxisome Proliferator-Activated Receptor agonists (i.e., seladelpar, elafibranor, lanifibranor), azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, systemic corticosteroids (equivalent to prednisone dose more than 10 mg per day); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, or nitrofurantoin) (within 12 weeks prior to screening).\n6. History of bowel surgery (gastrointestinal \\[bariatric\\] surgery in the preceding 1 year or undergoing evaluation for gastrointestinal surgery (bariatric surgery for obesity, extensive small-bowel resection) or orthotopic liver transplant or listed for orthotopic liver transplant.\n7. Type 1 diabetes mellitus.\n8. Unstable cardiovascular disease\n9. History of intracranial hemorrhage, arteriovenous malformation, bleeding disorder, coagulation disorders, or screening blood tests that, in the opinion of the Investigator, indicate clinically significant altered coagulability (e.g., Prothrombin Time, International Normalized Ratio, Activated partial thromboplastin time) at screening.\n10. An uncontrolled thyroid disorder\n11. History of myopathies or evidence of active muscle disease demonstrated by Creatine Phosphokinase ≥ 5 x Upper Limit of Normal at screening.\n12. For subjects with elevated baseline Alanine Aminotransferase or Aspartate Aminotransferase; Alanine Aminotransferase or Aspartate Aminotransferase exceeding by more than 50% on Visit 2 compared to Visit 1.\n13. Any of the following laboratory values at screening:\n\n    1. Platelets \\\u003C 100 × 10\\^9\u002FL\n    2. Albumin \\\u003C 3.5 g\u002FdL\n    3. Estimated Glomerular Filtration Rate \\\u003C 45 mL\u002Fmin\u002F1.73 m\\^2\n    4. Alanine Aminotransferase or Aspartate Aminotransferase \\> 250 U\u002FL\n    5. International Normalized Ratio greater than or equal to 1.7. However, participants with an International Normalized Ratio of 1.7 or above may be included if the elevated International Normalized Ratio is not attributable to liver disease.\n14. Participation in another interventional clinical study and receipt of any other investigational medication (within 12 weeks prior to randomization up to the end of the study).\n15. History of malignancy in the past 5 years and\u002For active neoplasm except resolved superficial non-melanoma skin cancer.\n16. Contraindications to Saroglitazar Magnesium or has any conditions affecting the ability to evaluate the effects of Saroglitazar Magnesium.\n17. Known allergy, sensitivity, or intolerance to the study medication, comparator, or formulation ingredients.\n18. Pregnancy-related exclusions, including the following:\n\n    1. Pregnant\u002Flactating female (including positive pregnancy test at screening).\n    2. Pregnancy should be avoided by male and female participants either by true abstinence or the use of acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study treatment.\n19. History or other evidence of severe illness or any other conditions that would make the participant, in the opinion of the Investigator, unsuitable for the study (such as poorly controlled psychiatric disease, Human Immunodeficiency Virus, coronary artery disease, or active gastrointestinal conditions that might interfere with drug absorption).\n20. Cirrhosis with Child-Pugh-Turcotte Class B or C having a score of 7 or above at screening.\n21. Participants with Model for End Stage Liver Disease 3.0 score of 12 or above. For participants on anticoagulation medication, baseline International Normalized Ratio determination for Model for End Stage Liver Disease score calculation should take anticoagulant use into account.\n22. Initiation or dose adjustment of anti-pruritic drugs (e.g., cholestyramine, naltrexone, rifampin, sertraline, or any investigational therapeutic) within 1 month prior to screening and till randomization.","80 Years",{"count":132,"type":20},89,[51],"Study of Saroglitazar Magnesium for PBC Patients with Incomplete Response or Intolerant to UDCA Therapy",[24],[24,137,56],"Saroglitazar Magnesium","NOT_YET_RECRUITING","2026-05-11",{"date":112,"type":29},{"date":142,"type":20},"2026-06",{"date":144,"type":20},"2028-11",{"name":146,"class":36},"Zydus Therapeutics Inc.",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":49,"phases":155,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":172},"100617480","the-value-of-spleen-stiffness-measurement-in-patients-with-pbc-100617480","NCT07319169","The Value of Spleen Stiffness Measurement in Patients With PBC","Inclusion Criteria:\n\n* ≥18y\n* Out-patient, followed at the UZ Brussels\n* Diagnosis of PBC based on cholestasis, AMA positivity and\u002For biopsy.\n* Under treatment with ursodeoxycholic acid and\u002For bezafibrate\n\nExclusion Criteria:\n\n* \\\u003C18y\n* Contra-indication for transient elastography (Fibroscan®) such as ascites or overt heart failure.",{"count":154,"type":20},125,[156],"NA","Recent evidence suggests that combining liver stiffness measurement (LSM) with spleen stiffness measurement (SSM) significantly improves risk stratification in patients with PBC. In a study the addition of spleen stiffness to liver stiffness enhanced the prediction of liver decompensation, providing a more precise evaluation of portal hypertension. Furthermore, when combined with platelet count, this approach effectively identified patients with a low probability of harboring HRVs. This could allow clinicians to safely avoid unnecessary endoscopic procedures in selected patients, improving patient comfort and reducing healthcare costs. Therefore, our patients participating in this trial will undergo follow up (every 6 months) as per Standard of care. This includes a blood draw, FibroScan and Ultrasound. Together with this, 2 questionnaires will be completed (not as per SOC) and during the FibroScan, a spleen stiffness measurement will be performed.",[24,159],"Spleen Stiffness",[161,162],"spleen stiffness","primary biliairy cholangitis","2026-04-30",{"date":165,"type":29},"2026-05-01",{"date":167,"type":20},"2026-07",{"date":169,"type":20},"2028-01",{"name":171,"class":91},"Universitair Ziekenhuis Brussel",1,{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":180,"enrollmentInfo":181,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":183,"conditions":184,"keywords":185,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":172},"100627527","biochemical-response-and-clinical-outcomes-in-patients-with-pbc-100627527","NCT07449793","Biochemical Response and Clinical Outcomes in Patients With PBC","Impact of Enhanced Biochemical Response on Clinical Outcomes in Patients With Primary Biliary Cholangitis: A Bidirectional Cohort Study","Inclusion Criteria:\n\n* Age above 18 years old, Male or Female,\n* Diagnosis of PBC meeting the 2018 American Association for the Study of Liver Diseases (AASLD) Practice Guidelines criteria;\n* Treatment with UDCA at a standard dose (13-15 mg\u002Fkg\u002Fday), with or without other second-line medications.\n\nExclusion Criteria:\n\n* Co-existing liver diseases, including but not limited to: Hepatitis C virus infection; Active Hepatitis B infection (patients who are HBsAg-negative and HBeAg-negative may be considered eligible per investigator assessment);\n* Autoimmune Hepatitis (AIH); Primary Sclerosing Cholangitis (PSC); Suspected or confirmed hepatocellular carcinoma;\n* Female subjects who is pregnant or breastfeeding during the study;\n* History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system;\n* Poor adherence or inability to complete the study follow-up.","85 Years",{"count":182,"type":20},3000,"This study is a bidirectional cohort study. The investigators conduct a bidirectional cohort study utilizing a database in mainland China, continuously collecting demographics, clinical symptoms, and biochemical characteristics of diagnosed PBC patients.\n\nThe study aims to analyze the association between varying post-treatment alkaline phosphatase (AKP) levels and complication-free survival rates, with the objective to develop and validate a predictive survival model.",[55,24],[186,110,187,188,189,190,191,192],"Primary Biliary Cirrhosis","Bile Duct Diseases","Biliary Tract Diseases","Digestive System Diseases","Cholangitis, Biliary","Cirrhosis, Biliary","Chronic Nonsuppurative Destructive Cholangitis","2026-02-26",{"date":195,"type":29},"2026-03-04",{"date":197,"type":20},"2026-02-01",{"date":199,"type":20},"2028-01-31",{"name":201,"class":91},"RenJi Hospital",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":49,"phases":212,"briefSummary":213,"conditions":214,"keywords":215,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":4},"100609565","phase-3-long-term-study-to-evaluate-the-safety-and-efficacy-in-participants-with-primary-biliary-cholangitis-of-saroglitazar-magnesium-v-on-clinical-outcomes-100609565","NCT07216235","Long-Term Study to Evaluate the Safety and Efficacy in Participants With Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes","A Phase 3b\u002F4, Multicenter, Parallel-Group, Double-Blind, Placebo Controlled, Two-Arm, Long-Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants With Primary Biliary Cholangitis (PBC)","EPICS-V","Inclusion Criteria:\n\nEach participant must meet all of the following criteria to be enrolled in this study:\n\n1. Is capable of understanding the written informed consent, provides signed and witnessed written informed consent, and agrees to comply with protocol requirements\n2. Is an adult male or female, must be ≥18 years of age at the time of signing informed consent\n3. Is receiving ursodeoxycholic acid (UDCA) for ≥12 months with a stable dose for ≥6 months prior to screening,and expected to remain on a stable dose during the study period OR Is unable to tolerate UDCA and did not receive UDCA in the past 3 months prior to screening\n4. Has a history of confirmed PBC diagnosis, as demonstrated by the presence of ≥2 of the following 3 diagnostic factors:\n\n   i. A history of elevated ALP levels for ≥6 months prior to screening ii. Positive antimitochondrial antibodies (AMA) titer OR if AMA is negative, then positive PBC-specific antibodies iii. Liver biopsy consistent with PBC diagnosis\n5. Has documented evidence of cirrhosis and has ALP \\>ULN and TB ≤5 × ULN\n\nExclusion Criteria:\n\nParticipants meeting any of the following criteria will be excluded from the study:\n\n1. Has consumption of 2 standard alcohol drinks per day (or 14 alcohol drinks per week) if male and 1 standard alcohol drink per day (or 7 alcohol drinks per week) if female for ≥3 consecutive months (12 consecutive weeks) within 5 years prior to screening\n2. Has known CPT B (having a score of ≥7) or CPT C (having a score of ≥10) cirrhosis classification at screening\n3. Has a Model for End-Stage Liver Disease (MELD)-Na score of ≥12 at screening\n4. Has a history or presence of any of the following other concomitant liver diseases at screening:\n\n   i. Chronic hepatitis B or C virus (HBV, HCV) infection. (Note: If a participant has been treated for the HCV infection and has been cured for a duration of \\>2 years prior to screening, they can be enrolled in the study. Participants who have seroconverted \\[hepatitis B surface antigen AND hepatitis B antigen is negative\\] may be included in this study.) ii. Primary sclerosing cholangitis iii. Alcohol-associated liver diseases iv. Autoimmune hepatitis (AIH)-PBC overlap syndrome v. Hemochromatosis vi. Metabolic dysfunction-associated steatohepatitis on historical biopsy vii. α-1 antitrypsin deficiency\n5. Has a history or presence of clinically significant hepatic decompensation, including the following:\n\n   i. Liver transplantation or currently placed on a liver transplant list ii. Complications of cirrhosis iii. Hepatorenal syndrome (Type I or II) iv. Known or suspected hepatocellular carcinoma or other hepatobiliary malignancies\n6. Use of the following medications (within 12 weeks prior to screening until the randomization \\[Day 1\\] visit): thiazolidinediones, fibrates, OCA, methotrexate, budesonide, and other systemic corticosteroids (equivalent to prednisone dose \\>10 mg); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid, and nitrofurantoin); any other newly approved treatments for PBC (eg, elafibranor, seladelpar)\n7. Has elevated baseline ALT, AST, or ALP values; ALT, AST, or ALP values increasing by \\>50% on Visit 2 compared to Visit 1\n8. Has any of the following laboratory values:\n\n   i. TB \\>5 × ULN ii. Platelets \\\u003C50 × 10\\^9\u002FL iii. Albumin \\\u003C2.8 g\u002FdL iv. ALP \\>10 × ULN v. Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73m\\^2 vi. ALT or AST \\>5 × ULN vii. International normalized ratio (INR) \\>1.7 in the absence of anticoagulant therapy viii. CPK \\> 2x ULN\n9. Has participated in another interventional clinical study and received any other investigational medication or medical device within 30 days or 5 half lives, whichever is longer, prior to screening\n10. Has a history of malignancy in the past 5 years and\u002For active neoplasm, which may diminish life expectancy (except resolved superficial nonmelanoma skin cancer, carcinomas in situ, or other stable, relatively benign conditions prior to screening)\n11. Has a known allergy, hypersensitivity, or intolerance to saroglitazar or any of the formulation ingredients\n12. Pregnancy-related exclusions, including the following:\n\n    i. If a female, who is pregnant (including a positive pregnancy test at screening), breastfeeding, intends to become pregnant, or is a woman of childbearing potential and not agreeing to use adequate contraceptive methods for at least 1 month after receiving the last dose of the IP ii. Male participants with WOCBP partners and female participants must avoid pregnancy either by true abstinence or the use of acceptable, effective contraceptive measures for the duration of the study and for at least 1 month after receiving the last dose of the IP\n13. Has a history or other evidence of severe illness or any other conditions, including cardiovascular, endocrine, hematological, gastrointestinal, neurological, or psychiatric disease, that, in the opinion of the investigator, would make the participant unsuitable for the study",{"count":211,"type":20},386,[51],"Long-Term Study to Evaluate the Safety and Efficacy in Participants with Primary Biliary Cholangitis of Saroglitazar Magnesium-V on Clinical Outcomes (EPICS-V)",[24],[137,24,56,216],"clinical outcome","2026-02-13",{"date":219,"type":29},"2026-02-18",{"date":221,"type":20},"2026-02",{"date":223,"type":20},"2032-11",{"name":146,"class":36},{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":49,"phases":235,"briefSummary":236,"conditions":237,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":247},"100496867","phase-2-fenofibrate-for-compensated-cirrhosis-patients-with-primary-biliary-cholangitis-100496867","NCT05749822","Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis","Fenofibrate Combined With Ursodeoxycholic Acid in Compensated Cirrhosis Patients With Primary Biliary Cholangitis Who Had an Inadequate Response to Ursodeoxycholic Acid","Inclusion Criteria:\n\n* Must have provided written informed consent\n* Age 18-75 years;\n* BMI 17-28 kg\u002Fm2\n* Male or female with a diagnosis of PBC, by at least two of the following criteria:\n\n  1. History of AP above ULN for at least six months;\n  2. Positive AMA titers (\\>1\u002F40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;\n  3. Documented liver biopsy result consistent with PBC.\n* Diagnosis of compensated cirrhosis, as demonstrated by the presence of ≥ 1 of the following 4 diagnostic factor\n\n  1. The histology was consistent with the diagnosis of liver cirrhosi;\n  2. Endoscopy shows esophageal and gastric varices or ectopic varices of digestive tract, excluding non cirrhotic portal hypertension;\n  3. Ultrasound or CT and other imaging examinations indicate the characteristics of liver cirrhosis or portal hypertension, such as splenomegaly, portal vein ≥ 1.3 cm, or liver stiffness measured by transient elastography\\>16.9 kPa;\n  4. Abnormal laboratory inspection indicators (2 out of 4): 1) PLT \\\u003C 100 × 109\u002FL, and no other reason can be explained; 2) Serum albumin\\\u003C35 g\u002FL, excluding malnutrition or kidney disease and other causes; 3) INR \\> 1.3 or PT prolongation (stop thrombolytic or anticoagulant drugs for more than 7 days); 4) AST\u002FPLT (APRI)\\>2）\n* Incomplete response to UDCA defined by ALP \\> 1.67 x ULN\n* Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0\n\nExclusion Criteria:\n\n* History or presence of other concomitant liver diseases.\n* ALT or AST \\> 5×ULN, TBIL \\> 3×ULN.\n* If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.\n* Allergic to fenofibrate or ursodeoxycholic acid.\n* Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.\n* Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.\n* Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).\n* Creatinine \\>1.5×ULN and creatinine clearance \\\u003C60 ml\u002Fmin.\n* Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).\n* Planned to receive an organ transplant or an organ transplant recipient.\n* Needing Liver transplantation within 1 year according to the Mayo Rick score.\n* Any other condition(s) that would compromise the safety of the subject or compromise","75 Years",{"count":234,"type":20},104,[104,51],"The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC).",[24],"2026-01-06",{"date":240,"type":29},"2026-01-08",{"date":242,"type":29},"2023-02-17",{"date":244,"type":20},"2027-12-31",{"name":246,"class":91},"Xijing Hospital of Digestive Diseases",12,{"id":249,"slug":250,"hasResults":11,"nctId":251,"briefTitle":252,"officialTitle":253,"acronym":4,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":232,"enrollmentInfo":255,"targetDuration":4,"studyType":49,"phases":257,"briefSummary":258,"conditions":259,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":260,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":266},"100497032","phase-3-fenofibrate-combined-with-ursodeoxycholic-acid-in-subjects-with-primary-biliary-cholangitis-100497032","NCT05751967","Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis","A Prospective, Multi-center, Randomized, Double-blind, Placebo-controlled Study: Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis and an Inadequate Response to Ursodeoxycholic Acid","Inclusion Criteria:\n\n* Must have provided written informed consent;\n* Age 18-75 years;\n* BMI 17-28 kg\u002Fm2\n* Male or female with a diagnosis of PBC, by at least two of the following criteria:\n\n  * History of AP above ULN for at least six months;\n  * Positive AMA titers (\\>1\u002F40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;\n  * Documented liver biopsy result consistent with PBC.\n* Incomplete response to UDCA defined by Xi'an criteria (ALP \\>2.5× ULN, AST\\>2×ULN or TBIL\\>1×ULN) after UDCA treatment for 4-6 weeks with at least one abnormal test in ALP or TBIL.\n\nExclusion Criteria:\n\n* History or presence of other concomitant liver diseases.\n* ALT\u002FAST \\> 5×ULN, TBIL \\> 3×ULN.\n* If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.\n* Allergic to fenofibrate or ursodeoxycholic acid.\n* Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.\n* Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.\n* Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).\n* Creatinine \\>1.5×ULN and creatinine clearance \\\u003C60 ml\u002Fmin.\n* Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).\n* Planned to receive an organ transplant or an organ transplant recipient.\n* Needing Liver transplantation within 1 year according to the Mayo Rick score.\n* Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator.",{"count":256,"type":20},150,[51],"Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line treatment for new-diagnosed primary biliary cholangitis (PBC) patients. However, up to 40% patients are insensitive to UDCA monotherapy, and evaluation of UDCA response at 12 months may result in long period of ineffective treatment. We aimed to develop a new criterion to reliably identify non-response patients much earlier. Recently, our team designed and validated a new early criterion for distinguishing high-risk PBC patients in a Chinese population for the first time. Our data indicated that PBC patients with ALP ≤ 2.5 × ULN, AST ≤ 2 × ULN, and TBIL ≤ 1 × ULN (Xi'an criterion) after 1 month UDCA treatment were likely to have better prognosis. It can be readily applied in the rapid identification of PBC patients who require additional therapeutic approaches. However, whether it is reasonable to apply it to the response definition of clinical research, and the guidance of PBC management and choice of second-line treatment, further research is needed.",[24],{"date":240,"type":29},{"date":262,"type":29},"2023-02-22",{"date":264,"type":20},"2027-12-01",{"name":246,"class":91},7,{"id":268,"slug":269,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":232,"enrollmentInfo":274,"targetDuration":4,"studyType":49,"phases":276,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":288},"100614650","phase-3-a-study-of-cs0159-in-patients-with-pbc-with-inadequate-response-or-intolerance-to-udca-100614650","NCT07282353","A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA","A Randomized, Double-Blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of CS0159 in Patients With Primary Biliary Cholangitis (PBC) With Inadequate Response or Intolerance to Ursodeoxycholic Acid (UDCA)","Inclusion Criteria:\n\n1. Must have given written informed consent (signed and dated) and any authorizations required by local law;\n2. When signing ICF age ≥18 years ≤75 years, male or female;\n3. Meets the diagnostic criteria of PBC, based on any two of the following criteria:\n\n   1. History of ALP above 1.0× ULN for at least 6 months\n   2. Positive antimitochondrial antibody (AMA) titer (\\>1:40 on immunofluorescence or M2 positive by ELISA) or positive PBC- specific antinuclear antibody (ANA) (either SP100 or GP210 positive)\n   3. Documented liver biopsy results consistent with PBC;\n4. UDCA≥6 months before randomization and a stable dose ≥3 months after the efficacy was poor \\[meeting inclusion criteria (5)a\\], or UDCA was not tolerated, and stop taking UDCA (no UDCA use for ≥3 months before randomization);\n5. Central laboratory parameters measured at screening period meet the following criteria:\n\n   1. ALP ≥1.67× ULN\n   2. ALT≤5× ULN\n   3. AST ≤5× ULN\n   4. TB \\\u003C2× ULN\n   5. Estimated glomerular filtration rate (eGFR) \\> 60mL\u002Fmin\u002F1.73m2 (calculated by CKD-EPI equation)\n   6. INR ≤ 1.0× ULN. For participants on anticoagulation therapy, INR must be maintained in the range required for prophylaxis for their specific disease\n   7. Platelet count ≥ 150× 109\u002FμL (No thrombocytopenia-related treatment within the past two weeks)\n   8. Albumin\\> 35g\u002FL\n   9. White blood cells count (WBC) \\>3×109\u002FL\n   10. Absolute neutrophil count (ANC) \\>1.5×109\u002FL\n   11. Hemoglobin A1c (HbA1c) ≤9.0%;\n6. Females of reproductive potential must use at least 1 barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male participants who are sexually active with female partners of reproductive potential must use barrier contraception, and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose.\n\n   \\-\n\nExclusion Criteria:\n\n1. Previous exposure to CS0159;\n2. History of allergy to the CS0159 or its excipients or drugs of similar chemical classes;\n3. Advanced PBC as defined by the Rotterdam criteria (albumin\\\u003C1.0×LLN AND TB \\>1.0× ULN);\n4. Patients who have had clinically significant complications of hepatic cirrhosis with clinically significant portal hypertension (CSPH), including the following:\n\n   1. History of liver transplantation, current placement on a liver transplant list, current MELD -Na score ≥ 12;\n   2. History of confirmed esophagogastric variceal bleeding;\n   3. Clinically significant ascites requiring intervention, such as sodium restriction, diuretic therapy, or therapeutic paracentesis;\n   4. Any secondary complications resulting from clinically significant ascites, such as spontaneous bacterial peritonitis, hepatorenal syndrome, or hepatic hydrothorax;\n   5. Hepatic encephalopathy requiring drug therapy;\n   6. Portopulmonary hypertension and\u002For hepatopulmonary syndrome;\n   7. Hepatocellular carcinoma;\n5. Other concomitant liver disease including:\n\n   1. Autoimmune hepatitis (AIH) (simplified AIH diagnostic score \\>6), PBC-AIH overlap syndrome, or overlap with other autoimmune liver diseases\n   2. Positive HBsAg or positive HCV RNA (tested for in case of known cured HCV infection or positive HCV Ab at screening)\n   3. Primary sclerosing cholangitis (PSC)\n   4. History or clinical evidence of Alcoholic liver disease (ALD)\n   5. Biopsy confirmed Non-alcoholic steatohepatitis (NASH)\n   6. Gilbert's Syndrome\n   7. History or evidence of alpha-1 antitrypsin deficiency\n   8. Liver stiffness measured by transient elastography (TE) \\> 16.9 Kpa;\n6. Patient has a positive test for HIV at screening, or active syphilis \\[defined as positive Treponema pallidum antibody (TP Ab) and a rapid plasma reagin (RPR) card test titer ≥1:8; for low titers (e.g., 1:1 or 1:2), clinical judgment is required to determine if it is active syphilis\\];\n7. Administration of the following medications are prohibited as specified below:\n\n   1. Use of medications, food, and drinks (e.g., grapefruit juice) that are strong or moderate CYP3A4 inhibitors or inducers within 14 days before randomization;\n   2. Use of P-glycoprotein (P-gp) substrate drugs within 14 days before randomization;\n   3. 2 months prior to randomization: fibrates, glitazones, seladelpar and elafibranor.\n   4. 3 months prior to randomization: obeticholic acid (OCA), azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, systemic corticosteroids and budesonide (˃2 weeks); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid isoniazid, or nitrofurantoin).\n   5. Patients with systemic treatment for pruritus (e.g., with bile acid sequestrants \\[BAS\\]) within 3 months prior to randomization.\n   6. 12 months prior to randomization: antibodies or immunotherapy directed against ILs or other cytokines or chemokines;\n8. Medical conditions that may cause non-hepatic increases in ALP (e.g., paget's disease);\n9. Patients with severe arrhythmia, or a QTcF interval corrected by Fridericia's formula ≥450 ms (males) or ≥470 ms (females) at screening \\[Fridericia's formula: QTcF=QT\u002F(RR\\^0.33)\\];\n10. History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the large intestine, eg, inflammatory bowel disease, prior or planned (during the study period) bariatric surgery (such as gastroplasty, roux-en-Y gastric bypass);\n11. History of malignancy (except for those with a disease-free survival of ≥5 years) or currently under evaluation for malignancy; except for cured squamous or non-invasive skin basal cell carcinoma and cervical carcinoma in situ;\n12. Drug abuse or heavy alcohol use from 12 months prior to randomization throughout the entire clinical study period. Heavy alcohol use is defined as an average weekly alcohol consumption of more than approximately 7 standard drinks for females and more than approximately 14 standard drinks for males. One standard drink is defined as any beverage containing 14g of pure alcohol, such as 12 oz\u002F360 mL of beer (5% alcohol), 8 oz\u002F240 mL of malt liquor (7% alcohol), 5 oz\u002F150 mL of wine (12% alcohol), or 1.5 oz\u002F45 mL of distilled spirits (40% alcohol);\n13. Poor blood pressure control is indicated after treatment by a systolic pressure greater than 160 mmHg or diastolic pressure greater than 100 mmHg during screening;\n14. Pregnancy, planned pregnancy, lactation;\n15. Treatment with any other investigational therapy or device within 30 days or within 5 half-lives, whichever is longer, prior to screening;\n16. Mental instability or incompetence that may compromise the validity of informed consent or ability to adhere to study requirements;\n17. Any other condition(s) that would compromise the safety of the patient or compromise the quality of the clinical study, as judged by the investigator.\n\n    \\-",{"count":275,"type":20},135,[51],"A Randomized, Double-Blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of CS0159 in Patients with Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (UDCA).",[24],"2025-12-29",{"date":281,"type":29},"2025-12-30",{"date":283,"type":29},"2025-12-01",{"date":285,"type":20},"2028-01-06",{"name":287,"class":91},"Cascade Pharmaceuticals, Inc",41,{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":232,"enrollmentInfo":296,"targetDuration":4,"studyType":49,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":4},"100572457","phase-2-th104-for-the-treatment-of-pruritus-in-primary-biliary-cholangitis-100572457","NCT06733519","TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis","Evaluation of TH104 for Moderate to Severe Pruritus in Primary Biliary Cholangitis: a Double-blind, Randomized, Placebo-controlled, Phase 2a Study","Inclusion Criteria:\n\n1. Men or women aged 18 to 75 years, inclusive, at the time of signing the informed consent form.\n2. Diagnosis of PBC, as demonstrated by the participant presenting with at least 2 of the following criteria at the Screening Visit:\n\n   1. history of sustained increased alkaline phosphatase (ALP) levels first recognized at least 6 months prior to the Screening Visit\n   2. positive antimitochondrial antibodies (AMA) titer (\\>1:40 titer on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay \\[ELISA\\])\n   3. PBC-specific antinuclear antibodies (antinuclear dot and nuclear rim positive)\n   4. liver biopsy consistent with PBC Note: Participants with compensated cirrhosis will be eligible for enrollment only after the DSMB reviewed the safety and tolerability of TH104 in the first 10 non-cirrhotic participants.\n3. Screening ALP value below 10 × upper limit of normal (ULN).\n4. Participants taking the following drugs may be enrolled to the study, as long as they are on stable doses for \\> 12 weeks prior to the Screening Visit; Ursodeoxycholic acid (UDCA) Obeticholic acid Elafibranor Seladelpar Fibrates such as bezafibrate and fenofibrate Cholestyramine Antihistamines\n5. Symptoms of pruritus - rated as NRS \\> 4 for worst daily score:\n\n   * At screening AND\n   * At least on 4 days during the 1-week baseline observation period.\n6. A woman is eligible to participate if she is not breast-feeding or pregnant, as confirmed by a negative serum human chorionic gonadotrophin (hCG) test or at least one of the following conditions applies:\n\n   1. Non-reproductive potential defined as pre-menopausal with a documented tubal ligation or hysterectomy; or post-menopausal defined as 12 months of spontaneous amenorrhea \\[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \\>40 mIU\u002FmL and estradiol \\\u003C40 pg\u002FmL (\\\u003C147 pmol\u002FL) is confirmatory\\]. Women on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods along with either a second form of highly effective contraception or barrier protection (condoms with spermicide) if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment;\n   2. Reproductive potential and agrees to follow one of the contraception options methods for the specified duration of time.\n\n   For men participating in the study and having a female partner - birth control methods described above will have to be used throughout the study.\n7. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.\n\nExclusion Criteria:\n\n1. Screening total bilirubin \\>2.0 x ULN.\n2. Screening alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>4 x ULN.\n3. Screening serum creatinine \\>2.5 mg\u002FdL (221 µmol\u002FL).\n4. History or presence of hepatic decompensation (e.g., variceal bleeds, encephalopathy, or poorly controlled ascites).\n5. History or presence of other concomitant liver diseases including hepatitis due to hepatitis B or C virus (HCV, HBV) infection, primary sclerosing cholangitis (PSC), alcoholic liver disease, definite autoimmune hepatitis or biopsy-proven non-alcoholic steatohepatitis (NASH\u002FMASH\u002FMAFLD).\n6. Thyroid stimulating hormone (TSH) out of normal ranges.\n7. Administration of the following drugs at any time during the 3 months prior to the Screening Visit: colchicine, methotrexate, azathioprine, opioids, opioids antagonists, or systemic corticosteroids.\n8. Current or chronic history of inflammatory bowel disease, chronic diarrhea, Crohn's disease, or diarrhea related to malabsorption syndromes.\n9. Based on averaged corrected QT interval (QTc) values of triplicate electrocardiograms (ECGs) obtained at least 5 minutes apart: QTc ≥450 msec; or QTc ≥480 msec in participants with Bundle Branch Block.\n10. History of sensitivity to any of the study medications (or components thereof) or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation.\n11. History of regular alcohol consumption within 6 months of the Screening Visit defined as an average weekly intake of \\>21 units for men or \\>14 units for women. One unit is equivalent to 8 g of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.\n12. A positive screening drug\u002Falcohol screen. A minimum list of drugs that will be screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids, and benzodiazepines.\n13. Where participation in the study would result in blood in blood sampling in excess of 500 mL within a 56-day period.\n14. Treatment with sertraline and\u002For rifampicin \\\u003C 4 weeks prior to the Screening Visit.\n15. Clinically significant abnormality of the buccal mucosa which could impact drug absorption.\n16. Participation in a clinical trial with an investigational product within 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer) before the first dosing in this study.\n17. Decompensated liver disease (encephalopathy, ascites, or Child Pugh score \\> 10 points). Participants with compensated cirrhosis will be eligible for enrollment after the DSMB reviewed the safety and tolerability of TH104 for the first 10 non-cirrhotic participants).",{"count":297,"type":20},40,[104],"A phase 2a, multicenter, randomized, double-blind, placebo-controlled study of TH104 in primary biliary cholangitis (PBC) participants with moderate to severe pruritus.",[108,24],"2025-09-02",{"date":303,"type":29},"2025-09-09",{"date":305,"type":20},"2026-06-01",{"date":307,"type":20},"2027-06-01",{"name":309,"class":36},"Tharimmune Inc",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":4,"enrollmentInfo":316,"targetDuration":77,"studyType":21,"phases":4,"briefSummary":317,"conditions":318,"keywords":319,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":331},"100297047","swiss-primary-biliary-cholangitis-cohort-study-100297047","NCT03146910","Swiss Primary Biliary Cholangitis Cohort Study","Inclusion Criteria:\n\n* diagnose of Primary biliary cholangitis (according to EASL Clinical Practice Guidelines: management of cholestatic liver diseases).\n* Subjects with isolated anti-mitochondrial antibodies and\u002For isolated PBC-specific anti-nuclear antibodies are also included\n* Patients\u002Fsubjects aged at least 18 years and living in Switzerland are included\n\nExclusion Criteria:\n\n* N\u002FA",{"count":76,"type":20},"Research project in which biological material is sampled and health-related medical data is collected. In addition, already existing health-related medical data are used for further research. Coded data are used.",[56,24],[56,24,320,321],"Cohort","AILD","2025-08-13",{"date":324,"type":29},"2025-08-17",{"date":326,"type":29},"2017-02-15",{"date":328,"type":20},"2030-12-31",{"name":330,"class":91},"Fondazione Epatocentro Ticino",13,{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":4},"100602338","monitoring-the-response-of-combination-ursodiol-and-seladelpar-treatment-100602338","NCT07122206","Monitoring the Response of Combination Ursodiol and Seladelpar Treatment","Monitoring the Response of Combination Ursodiol and Seladelpar Treatment in Primary Biliary Cholangitis Using Invasive Markers","Inclusion Criteria:\n\n* Patients must have a confirmed diagnosis PBC as per established diagnostic criteria.\n* Adults aged 18 years and older.\n* Patients undergoing treatment with ursodiol (ursodeoxycholic acid) for PBC or who demonstrate intolerance to ursodiol due to side effects and persistent ALP \\> normal.\n* Patients undergoing treatment with seladelpar for PBC.\n* Patients must be willing and able to provide written informed consent for participation in the study.\n\nExclusion Criteria:\n\n* Patients that do not meet inclusion criteria.\n* Patients with other chronic liver diseases, such as hepatitis B, hepatitis C, non-alcoholic steatohepatitis (NASH), alcoholic liver disease, or other autoimmune liver diseases.\n* Patients who have undergone a liver transplant.\n* Presence of cirrhosis or hepatic decompensation at the time of study enrollment.\n* Patients with significant comorbid conditions that may interfere with the study outcomes, such as severe cardiovascular, renal, or pulmonary diseases.\n* Pregnant or breastfeeding women, due to potential risks to the fetus or infant.\n* Inability or unwillingness to comply with the study protocol, including scheduled visits, tests, and procedures.",{"count":340,"type":20},100,"This study aims to provide comprehensive insights into the therapeutic effects of combination treatment with ursodiol and seladelpar in PBC patients by assessing biochemical responses using biomarkers such as ALP and total bilirubin.",[24],"2025-08-07",{"date":345,"type":29},"2025-08-14",{"date":347,"type":20},"2025-08",{"date":349,"type":20},"2027-08",{"name":351,"class":91},"Methodist Health System",{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":358,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":4,"enrollmentInfo":360,"targetDuration":77,"studyType":21,"phases":4,"briefSummary":362,"conditions":363,"keywords":364,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":376},"100450923","national-database-on-primary-biliary-cholangitis-100450923","NCT05151809","National Database on Primary Biliary Cholangitis","Multicenter, Nationwide, Observational, Retrospective and Prospective Study Based on the Development of a Patients Database Linked to a Biological Sample Storage","PBC322","Inclusion Criteria:\n\nAll PBC patients living in Italy and aged at least 18 years can be included in the database. According to well-established criteria, PBC is diagnosed in subjects who fulfill two of the three of following criteria:\n\n* elevated alkaline phosphatase and \u002For GGT;\n* positive anti-mitochondrial autoantibodies (titer ≥ 1:40) or PBC-specific antinuclear antibodies (gp-210 and sp100);\n* characteristic histological features of florid bile ducts lesions and granulomatous lesion.\n\nExclusion Criteria:\n\nThe patient has explicitly declared his\u002Fher unwillingness to participate to the study",{"count":361,"type":20},6000,"Primary biliary cholangitis (PBC) is a rare, autoimmune, cholestatic liver disease. No data about the disease epidemiology exist in Italy. Therefore this study aims to develop a national PBC patient database linked to a biological sample storage.",[24],[24,365,366],"Disease phenotypes","National Database","2025-07-24",{"date":369,"type":29},"2025-07-25",{"date":371,"type":29},"2019-09-19",{"date":373,"type":20},"2029-01-24",{"name":375,"class":91},"University of Milano Bicocca",55,{"id":378,"slug":379,"hasResults":11,"nctId":380,"briefTitle":381,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":232,"enrollmentInfo":384,"targetDuration":4,"studyType":49,"phases":386,"briefSummary":387,"conditions":388,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":392,"completionDateStruct":394,"leadSponsor":396,"locationsCount":172},"100544172","phase-2-fenofibrate-in-patients-with-primary-biliary-cholangitis-pbc-100544172","NCT06365424","Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)","An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)","Inclusion Criteria:\n\n* Must have given written informed consent (signed and dated)\n* Participated in the PBC study with fenofibrate (NCT02823353)\n* Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose\n\nExclusion Criteria:\n\n* Treatment-related adverse event (AE) leading to fenofibrate discontinuation\n* A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)\n* Known history of other liver diseases\n* For females, pregnancy or breast-feeding\n* Long-term use of immunosuppressive agents\n* Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator",{"count":385,"type":20},117,[104,51],"An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)",[24],"2025-07-01",{"date":391,"type":29},"2025-07-02",{"date":393,"type":29},"2017-04-08",{"date":395,"type":20},"2027-04",{"name":246,"class":91},{"id":398,"slug":399,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":405,"enrollmentInfo":406,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":408,"conditions":409,"keywords":413,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":421,"completionDateStruct":423,"leadSponsor":425,"locationsCount":427},"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","70 Years",{"count":407,"type":20},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.",[410,24,411,412],"Decompensated Liver Cirrhosis","Primary Sclerosing Cholangitis","Hepato-cellular Carcinoma",[414,415,416,417],"Liver transplantation","predictive models","data collection cohort","liver transplantation candidates","2025-05-06",{"date":420,"type":29},"2025-05-09",{"date":422,"type":29},"2025-02-04",{"date":424,"type":20},"2029-02-04",{"name":426,"class":91},"Assistance Publique - Hôpitaux de Paris",22,{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":4,"enrollmentInfo":436,"targetDuration":4,"studyType":49,"phases":438,"briefSummary":440,"conditions":441,"keywords":442,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":172},"100412414","phase-4-clinical-research-of-tapering-udca-in-pbc-patients-with-a-complete-response-100412414","NCT04650243","Clinical Research of Tapering UDCA in PBC Patients With a Complete Response","Clinical Research of Tapering Ursodeoxycholic Acid in Primary Biliary Cholangitis Patients With A Complete Response","UDCA PBC","Inclusion Criteria:\n\n* Satisfied the diagnostic criteria of PBC by the AASLDin 2000;\n* Age≥18 years\n* Clinical stage 2 and 3 (i.e. abnormal liver function and symptomatic phase);\n* Patients with improved liver biochemical index( ALP and AST≤1.5× upper limit of normal, with a normal bilirubin level) after 6 to 12 months treatment of UDCA;\n* Informed consent obtained.\n\nExclusion Criteria:\n\n* Overlapped with other liver diseases (such as HBV, HCV, alcoholic cirrhosis, etc.) or serum ALT, AST more than 2 ULN;\n* Decompensation of liver function (Child grade B\u002FC);\n* Complicated with important organ failure (such as renal insufficiency), serious infection or other serious complications;\n* Pregnancy, preparation for pregnancy or pregnancy Lactation, psychiatric subjects, etc.;\n* Participating in other clinical trials or participated in other clinical trials in three months.",{"count":437,"type":20},90,[439],"PHASE4","This study explores the feasibility of the reducing medication regimen for Ursodeoxycholic Acid(UDCA) in the treatment of primary biliary cholangitis. The participants will be distributed randomly into two experimental groups and one control group. The two experimental groups will receive reduced dosage of UDCA at different level, while the control group will receive standard dosage of UDCA. The effect of therapy will be evaluated every three months.",[24],[443,444],"ursodeoxycholic acid","reducing medication regimen","2025-03-26",{"date":447,"type":29},"2025-04-01",{"date":449,"type":29},"2020-01-21",{"date":451,"type":20},"2025-05",{"name":453,"class":91},"Peking Union Medical College Hospital",{"id":455,"slug":456,"hasResults":11,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":405,"enrollmentInfo":462,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":464,"conditions":465,"keywords":466,"overallStatus":138,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":478},"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":463,"type":20},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.",[410,24,411,412],[414,467,468,469],"Predictive models","Liver transplantation candidates","prospective longitudinal study","2024-12-10",{"date":472,"type":29},"2024-12-13",{"date":474,"type":20},"2025-01",{"date":476,"type":20},"2027-10",{"name":426,"class":91},5,{"id":480,"slug":481,"hasResults":11,"nctId":482,"briefTitle":483,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":11,"sex":17,"minAge":46,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":487,"conditions":488,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":172},"100509899","detection-program-for-patients-with-primary-biliary-cholangitis-lost-in-the-system-100509899","NCT05919433","Detection Program for Patients With Primary Biliary Cholangitis Lost in the System","RESCAT","Inclusion Criteria:\n\n* Patients with positive AMA and\u002For with positive ANA anti-gp210 or anti-sp100 identified in the computer databases of each of the participating centers.\n* Adults (≥18 years)\n\nExclusion Criteria:\n\n* Patients with Overlap Syndrome (PBC overlap with Autoimmune Hepatitis (AIH))",{"count":76,"type":20},"Primary biliary cholangitis (PBC) has been considered a rare disease and its management has been limited by the lack of therapeutic alternatives. PBC is a slowly progressing chronic liver disease characterized by an immune-mediated destruction of the intrahepatic bile ducts, which leads to cholestasis, portal inflammation, and ultimately liver cirrhosis and its associated complications (ascites, portal hypertension, etc), if not treated effectively. Thus, early diagnosis and close management of these patients with PBC is essential. First-line treatment with ursodeoxycholic acid (UDCA) improves liver biochemical parameters, delays histological progression, and increases liver transplant-free survival and overall survival. However, up to 40% of patients are non-responders to UDCA. Obeticholic acid (OCA) is recommended as second-line therapy in combination with UDCA for patients with an inadequate response to UDCA or as monotherapy in cases of UDCA intolerance.\n\nAccording to current clinical guidelines, the diagnosis of PBC includes a combination of elevated alkaline phosphatase (ALP) levels and the presence of anti-mitochondrial antibodies (AMA) (titer \\>1:40) and\u002For anti-nuclear antibodies (ANA) anti-gp210 or anti-sp100. AMA are highly sensitive and specific for PBC and are detected in nearly 95% of PBC patients. A liver biopsy is not necessary unless there is an elevation of ALP without the presence of specific AMA and\u002For anti-gp210 or anti-sp100 ANA or if coexistence with other liver diseases is suspected (autoimmune hepatitis, hepatic steatosis).\n\nThe incidence of PBC has increased in recent years due to an increase in the diagnosis of cases in the initial phases, better awareness in the medical community and the development of more sensitive diagnostic tests. However, up to 31% of patients with PBC are lost without follow-up. The correct identification of patients with PBC is essential so that they can benefit from an adequate treatment and modify disease progression. To date, two studies (one Spanish and one Portuguese) showed that 27% and 45.5% of the patients lost with PBC presented advanced fibrosis, respectively.\n\nThe objective of this study is to identify, through computerized data, patients with PBC who may be lost in the system and evaluate their clinical, analytical and demographic characteristics, and in a second phase, provide access to follow-up in specialized consultations.",[24],"2023-06-16",{"date":491,"type":29},"2023-06-26",{"date":493,"type":29},"2023-05-01",{"date":495,"type":20},"2028-12-31",{"name":497,"class":91},"Hospital Mutua de Terrassa"]