[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-biliary-cholangitis-pbc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-biliary-cholangitis-pbc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,41,78,105,133,155,170,190,213,244,274,295],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100517384","phase-3-a-long-term-study-of-elafibranor-in-adult-participants-with-primary-biliary-cholangitis-100517384",false,"NCT06016842","A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis","A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC)","ELFIDENCE","Inclusion Criteria :\n\n* Male or female participants must be ≥18 years of age at the time of signing the informed consent.\n* Participants with a definite or probable diagnosis of primary biliary cholangitis (PBC)\n* Participants with cirrhosis at SV1. • Participants must be Child Pugh A or Child Pugh B.\n* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria :\n\n* History or presence of other concomitant liver disease including but not limited to:\n\n  * i) Primary sclerosing cholangitis (PSC).\n  * ii) Autoimmune hepatitis (AIH) by simplified Diagnostic Criteria of the International Autoimmune Hepatitis Group (IAIHG) ≥6, or if treated for an overlap of PBC with AIH, or if there is clinical suspicion and evidence of overlap AIH features, that cannot be explained alone by insufficient response to UDCA.\n  * iii) Positive hepatitis B surface antigen (HBsAg). Participants with negative HBsAg and positive hepatitis B core antibody (HBcAb) may be eligible if hepatitis B virus deoxyribonucleic acid (HBV DNA) is negative.\n  * iv) Hepatitis C virus (HCV) infection defined by positive anti-HCV antibody and positive HCV ribonucleic acid (RNA) (Note: Participants with positive anti-HCV antibody due to previously treated HCV infection, may be enrolled if a confirmatory HCV RNA is undetectable and sustained viral response has been documented).\n  * v) Alcohol-associated liver disease (ALD).\n  * vi) Nonalcoholic steatohepatitis (NASH).\n  * vii) Other chronic liver diseases, such as alpha-1 antitrypsin deficiency.\n* History or presence of clinically significant hepatic decompensation, including:\n\n  * i) History of liver transplantation, current placement on a liver transplant list, current model for end-stage liver disease including (MELD) 3.0 score \\>12 due to hepatic impairment.\n  * ii) Evidence of complications of cirrhosis, including hepatic decompensation or evidence of significant portal hypertension complications including presence of uncontrolled ascites; history of variceal bleeding or related interventions (e.g. variceal banding, or transjugular intrahepatic portosystemic shunt placement); presence of hepatic encephalopathy Grade 2 or higher per West-Haven criteria; history or presence of spontaneous bacterial peritonitis. Note: participants with low-risk varices (Grade I) without history of bleeding or other treatment may be eligible to enrol.\n  * iii) Hepatorenal syndrome (HRS) (type I or II ). • vi) Hospitalisation for liver-related complication within 12 weeks prior to SV1.\n* Known history of human immunodeficiency virus (HIV) infection or having a positive confirmatory test for HIV type 1 or 2.\n* Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).\n* Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematologic, gastrointestinal, neurological, or psychiatric disease as evaluated by the investigator; other clinically significant conditions that are not well controlled.\n* Non-hepatic medical conditions that may diminish life expectancy to \\\u003C2 years, including known cancers.\n* History of hepatocellular carcinoma.\n* Alpha-fetoprotein (AFP) \\>20 ng\u002FmL with 4-phase liver computerised tomography (CT) or magnetic resonance imaging (MRI) imaging suggesting presence of hepatocellular carcinoma.\n* Known malignancy or history of malignancy within the last 5 years. Participants with non-melanoma skin cancer, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n* Administration of the following medications is prohibited during the study, and prior to the study as per the timelines specified below: • i) 3 months prior to baseline: fibrates, seladelpar, glitazones, obeticholic acid, azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid or nitrofurantoin).\n* Participants who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or 5 half-lives, whichever is longer, prior to the screening period.\n\n  i) If the previous study was for an experimental therapy being studied for potential benefit in PBC, and the potential therapeutic agent was proven to have no beneficial effect in PBC and there are no safety concerns, the participant may enrol after 30 days or 5 half-lives from the last dose of the therapeutic agent, whichever is longer.ii) For therapeutic agents being studied for potential benefit in PBC for which it is still unclear if there may be a potential benefit, participants may enrol after 6 months from the last dose of the therapeutic agent.\n* Electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) \\>450 msec in males or QTcF \\>470 msec in females for participants without bundle branch block. For participants with bundle branch block or other intraventricular conduction delay, a longer QTcF \\>480 msec would be exclusionary.\n* Total bilirubin (TB) \\>5x ULN\n* Alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\>5x ULN at SV1\n* Creatinine phosphokinase (CPK) \\>2x ULN.\n* Platelet count \\\u003C50,000\u002FμL\n* International normalised ratio (INR) \\>1.8 in the absence of anticoagulant therapy.\n* Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73m2 per the Modification of Diet in Renal Disease (MDRD)-6 Study formula at SV1.\n* Significant renal disease, including nephritic syndrome, chronic kidney disease (CKD) (defined as participants with evidence of significantly impaired kidney function or underlying kidney injury).\n* For female participants: known current pregnancy, or has a positive serum pregnancy test, or is breastfeeding.\n* Participants unwilling or unable to be abstinent from alcohol during the study.\n* History of alcohol abuse, or other substance abuse within 1 year prior to SV1.\n* Known hypersensitivity to elafibranor or to any of the excipients of the investigational product(s).\n* Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.\n* Any other condition that, in the opinion of the investigator, would interfere with study participation or completion, or would put the participant at risk, including a potential participant assessed as being at high risk of noncompliance with the study.\n* Alkaline phosphatase (ALP) ≥10x ULN.\n* Albumin \\\u003C2.8 g\u002FdL due to impaired hepatic function.","ALL","18 Years",{"count":20,"type":21},276,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver).\n\nPBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage.\n\nThe liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.\n\nThis study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant.\n\nThe main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death).\n\nThis study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.",[27],"Primary Biliary Cholangitis (PBC)","RECRUITING","2026-07-01",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":32},"2023-08-31",{"date":36,"type":21},"2029-05-31",{"name":38,"class":39},"Ipsen","INDUSTRY",186,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":53,"conditions":54,"keywords":57,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100645171","phase-2-the-safety-and-efficacy-of-upadacitinib-in-refractory-autoimmune-related-cholangitis-and-atopic-dermatitis-with-moderate-to-severe-itching-100645171","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.","70 Years",{"count":50,"type":21},44,[52],"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.",[27,55,56],"Primary Sclerosing Cholangitis (PSC)","Atopic Dermatitis (AD)",[27,55,56,58,59,60,61,62,63,64,65,66],"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":29,"type":32},{"date":71,"type":21},"2026-06-01",{"date":73,"type":21},"2028-05-31",{"name":75,"class":76},"RenJi Hospital","OTHER",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100616379","phase-1-a-two-part-study-to-investigate-the-effects-in-adults-of-two-doses-of-golexanolone-in-patients-with-primary-biliary-cholangitis-pbc-with-fatigue-and-cognitive-dysfunction-100616379","NCT07304843","A Two-part Study to Investigate the Effects in Adults of Two Doses of Golexanolone in Patients With Primary Biliary Cholangitis (PBC) With Fatigue and Cognitive Dysfunction","A Randomised, Double-blind, Placebo-controlled, Two-part Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Preliminary Efficacy of Two Dose Levels of Golexanolone in Subjects With Primary Biliary Cholangitis (PBC), Fatigue, and Cognitive Dysfunction","Inclusion Criteria:\n\n* Male and female subjects age ≥ 18 years\n* Diagnosis of PBC based on the presence of ≥2 of 3 key disease characteristics\n* Clinically significant fatigue defined for the purposes of this study as a PBC-40 fatigue domain score of ≥29 at screening\n* Clinically significant cognitive symptoms, defined for the purposes of this study as a PBC-40 cognitive domain ≥16 at screening\n* Stable PBC SoC therapy (if any),for at least 3 months prior to randomisation\n* For all women of childbearing potential (WOCBP) a negative pregnancy test at screening and a negative urine dip-stick pregnancy test at baseline, prior to first dose of IMP\n* WOCBP must be willing to use a contraceptive method with a failure rate of \\\u003C 1% and agree to continue use of this method for the duration of the study and thereafter for 1 month after the last dosing of the IMP\n* Females of non-childbearing potential must have documented tubal ligation or hysterectomy; or be post-menopausal\n* Fertile male subjects must be willing to use condom and assure that their female partner will use contraceptive methods with a failure rate of \\\u003C 1%\n* Willing and able to give informed consent\n* The subject should be judged by the Investigator to be lucid and oriented to person, place, time, and situation when giving the informed consent\n\nExclusion Criteria:\n\n* Child-Pugh class B or C cirrhosis\n* Clinical evidence of hepatic decompensation (e.g. current or prior HE, ascites, or variceal bleeding)\n* History of hepatocellular carcinoma\n* Bilirubin \\>1.5 x ULN\n* Glomerular filtration rate (GFR) \\\u003C35 mL\u002Fmin\u002F1.73m2\n* Low Haemoglobin (HB), i.e. subjects with moderate\u002Fsevere anaemia\n* Low S-B12 or low P-folate\n* Evidence of biliary obstruction\n* Any positive result on screening for human immunodeficiency virus (HIV), or hepatitis B (serum hepatitis B surface antigen positive)\n* Prolonged QTcF (\\>500 ms), or any clinically significant abnormality in the resting ECG, as judged by the Investigator (at screening)\n* Concomitant disease characterised by chronic fatigue and\u002For cognitive impairment\n* Clinically significant bowel disease, including obstruction, active inflammatory bowel disease, or malabsorption\n* Clinically significant sleep apnoea\n* An uncontrolled thyroid disorder\n* Subjects with a history of or currently active immune disorders (i.e. uncontrolled) other that PBC (including autoimmune disease) and\u002For diseases requiring immunosuppressive drugs\n* Clinical diagnosis of autoimmune hepatitis overlap\n* The presence, as judged by the Investigator, of clinically significant concomitant illness which would jeopardise safe participation in the study and \u002For the interpretation of study findings\n* Regular use of prescribed or over the counter (OTC) medications known to cause fatigue or cognitive dysfunction\n* Use of prohibited medications within 14 days prior to randomisation\n* Anticipated change in PBC medication and\u002For significant medical or surgical intervention within the duration of the study\n* Regular (more than 1 week per month) alcohol consumption in excess of 14 units per week\n* Administration of another new chemical entity or has participated in any other clinical study that included drug treatment with the last administration within 3 months prior to administration of IMP in this study\n* Females who are pregnant, nursing or actively trying to conceive a child\n* Expected inability to swallow the required number of IMP capsules at the applicable dose level\n* History of severe allergy\u002Fhypersensitivity or on-going allergy\u002Fhypersensitivity, as judged by the Investigator",{"count":86,"type":21},84,[88,52],"PHASE1","The present phase 1b\u002F2 randomised, double-blind, placebo-controlled, two-part study is designed to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary efficacy of two dose levels of golexanolone compared with placebo among subjects with a history of non-cirrhotic or Child-Pugh class A cirrhotic Primary Biliary Cholangitis (PBC) with clinically significant fatigue and cognitive symptoms on stable background standard of care (SoC) PBC medication. The objectives of this research study are to assess the safety and tolerability as well the pharmacokinetic (PK) characteristics of golexanolone administered 40 mg BID for 5 days in the target population (part A) and to assess the safety and tolerability, the effects of golexanolone on health-related quality of life (HRQoL), including fatigue, day-time sleepiness and cognitive function as well as Investigator's overall impression of treatment effect of 28 days twice per day (BID) treatment with two dose levels of golexanolone versus placebo (part B).",[27],[92,93,94],"PBC","Cognition","Fatigue","2026-06-25",{"date":97,"type":32},"2026-06-26",{"date":99,"type":32},"2023-04-14",{"date":101,"type":21},"2026-09-30",{"name":103,"class":39},"Umecrine Cognition AB",40,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":77},"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":114,"type":21},3000,"OBSERVATIONAL","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.",[27,118],"Primary Biliary Cholangitis",[120,121,122,123,63,65,64,124],"Primary Biliary Cirrhosis","Cholangitis","Bile Duct Diseases","Biliary Tract Diseases","Chronic Nonsuppurative Destructive Cholangitis","2026-02-26",{"date":127,"type":32},"2026-03-04",{"date":129,"type":21},"2026-02-01",{"date":131,"type":21},"2028-01-31",{"name":75,"class":76},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":77},"100574120","phase-3-fenofibrate-in-primary-biliary-cholangitis-a-real-world-study-100574120","NCT06755151","Fenofibrate in Primary Biliary Cholangitis: a Real World Study","An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis (PBC)","Inclusion Criteria:\n\n1. Must have given written informed consent (signed and dated)\n2. Completed in a PBC study with fenofibrate(NCT05749822,NCT06174402)\n3. ALP\\> 1\\*ULN\n4. 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\n1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar\n2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results","75 Years",{"count":142,"type":21},300,[24],"An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination with Ursodeoxycholic Acid in Subjects with Primary Biliary Cholangitis (PBC)",[27],"2026-01-06",{"date":148,"type":32},"2026-01-08",{"date":150,"type":32},"2024-01-17",{"date":152,"type":21},"2035-12",{"name":154,"class":76},"Xijing Hospital of Digestive Diseases",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":138,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":161,"targetDuration":4,"studyType":22,"phases":163,"briefSummary":144,"conditions":164,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":165,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":169,"locationsCount":77},"100574150","phase-3-fenofibrate-in-combination-with-ursodeoxycholic-acid-in-primary-biliary-cholangitis-a-real-world-study-100574150","NCT06755541","Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study","Inclusion Criteria:\n\n1. Must have given written informed consent (signed and dated)\n2. Completed in a PBC study with fenofibrate(NCT05751967)\n3. 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\n1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar\n2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results",{"count":162,"type":21},150,[24],[27],{"date":148,"type":32},{"date":167,"type":32},"2024-01-30",{"date":152,"type":21},{"name":154,"class":76},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":177,"targetDuration":4,"studyType":22,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":77},"100615734","phase-3-firefly-trial-fenofibrate-intervention---randomized-evaluation-in-first-line-pbc-therapy-100615734","NCT07296458","FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy","A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Clinical Trial of Fenofibrate in Treatment-Naïve Patients With Primary Biliary Cholangitis","Inclusion Criteria:\n\n1. Voluntarily join the group and be able to understand and sign the informed consent form;\n2. Age: 18 years old or above and below 75 years old;\n3. The diagnosis of primary biliary cholangitis follows the AASLD international diagnostic and treatment guidelines (meeting two of the following three criteria: positive AMA or gp210, sp100; elevated serum ALP; pathological manifestations of non-suppurative cholangitis and interlobular bile duct destruction);\n4. The patient did not receive UDCA and fenofibrate treatment in the 6 months before enrollment, and ALP was greater than the upper limit of normal (ULN).\n\nExclusion Criteria:\n\n1. Combined liver diseases caused by other factors: including viral hepatitis, chronic alcoholic hepatitis, steatohepatitis, drug-induced hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, etc;\n2. Pregnant women, lactating women, or those who plan to give birth during the study period;\n3. Individuals who are allergic to fenofibrate or ursodeoxycholic acid;\n4. At the time of diagnosis or in the past, there have been variceal bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis, hepatocellular carcinoma, and hepatorenal syndrome;\n5. Individuals with a history of severe diseases or functional failures in the heart, cerebrovascular system, kidneys, respiratory system, as well as mental illnesses (including those caused by alcohol and drug abuse);\n6. Transaminase greater than 5×ULN, or total bilirubin greater than 3×ULN;\n7. Creatinine level greater than 1.5×ULN;\n8. Glomerular filtration rate (GFR) ≤ 45 mL\u002Fmin\u002F1.73 m2;\n9. International normalized ratio (INR) ≥ 1.5 (for patients undergoing anticoagulant therapy, an INR value within the therapeutic target range is sufficient);\n10. Subjects who have received treatment with obeticholic acid and other fibrates (such as gemfibrozil, bezafibrate, pemafibrate, Elafibranor, Seladelpar, Lanifibranor, Saroglitizar, etc.) within the previous 6 weeks prior to screening;\n11. Screening for individuals who have taken colchicine, methotrexate, azathioprine, or undergone systemic hormone therapy for more than 2 weeks within the previous 2 months;\n12. Is currently undergoing treatment with immunosuppressants (such as cyclosporine, tacrolimus, and related biologics);\n13. Plan to receive organ transplantation or have already undergone organ transplantation;\n14. Clear history of HIV infection or HIV antibody positive during the screening period;\n15. Screen for individuals with a clear history of malignant tumor or anti-tumor treatment within the previous 2 years;\n16. Other situations that researchers judge as unsuitable for enrollment.",{"count":178,"type":21},132,[24],"The goal of this clinical trial is to learn if the drug Fenofibrate works to treat adults with a liver disease called Primary Biliary Cholangitis (PBC) who have not received previous treatment. It will also learn about the safety of Fenofibrate. The main questions it aims to answer are:\n\nIs Fenofibrate better at helping the liver return to normal function (measured by a blood test called ALP) than the standard medication, Ursodeoxycholic What kind of medical problems do participants have when taking Fenofibrate compared to those taking UDCA?\n\nResearchers will compare Fenofibrate to the active drug UDCA (the current standard treatment) to see which one works better.\\*\\*\n\nParticipants will:\n\nBe randomly assigned to take either Fenofibrate plus a UDCA placebo, or UDCA plus a Fenofibrate placebo, every day for 12 months. (Neither they nor their doctor will know which group they are in.) Visit the clinic 5 times over the year (at 1, 3, 6, 9, and 12 months) for check-ups, blood tests, and questionnaires.\n\nUndergo a special scan (like FibroScan) to measure liver stiffness at some visits.\n\nBe encouraged to have a liver biopsy at the start and end of the study to provide detailed information about liver health (this is optional).",[27],"2025-12-20",{"date":184,"type":32},"2025-12-29",{"date":186,"type":32},"2025-12-15",{"date":188,"type":21},"2028-12-31",{"name":154,"class":76},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":199,"conditions":200,"keywords":201,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":77},"100608770","early-diagnosis-of-primary-biliary-cholangitis-pbc-in-patients-with-positive-anti-mitochondrial-antibodies-ama-and-normal-alkaline-phosphatase-alp-100608770","NCT07205874","Early Diagnosis of Primary Biliary Cholangitis (PBC) in Patients With Positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP)","Inclusion Criteria:\n\n* Signed informed consent\n* Positive AMA (≥1:40 titer)\n* Persistently normal ALP\n\nExclusion Criteria:\n\n* Previously diagnosed with PBC, autoimmune hepatitis, or primary sclerosing cholangitis\n* Under treatment with ursodeoxycholic acid, fibrates, biologics or immunosuppressants including oral steroids\n* Contraindications for liver biopsy\n* Concomitant debilitating disease or poor prognosis\n* Pregnancy","80 Years",{"count":198,"type":21},80,"The goal of this observational study is to achieve early diagnosis of Primary Biliary Cholangitis (PBC) in patients with positive Anti-Mitochondrial Antibodies (AMA) and Normal Alkaline Phosphatase (ALP) in adults aged 18-80 years with positive AMA and normal ALP. The main question it aims to answer is:\n\n• Are there any predictive factors for histological PBC in patients with positive AMA and normal ALP? Participants will undergo a liver biopsy and specific blood tests if eligible based on inclusion and exclusion criteria.",[27],[27,202,203],"Anti-Mitochondrial Antibodies (AMA)","Alkaline Phosphatase (ALP)","2025-09-25",{"date":206,"type":32},"2025-10-03",{"date":208,"type":32},"2025-09-15",{"date":210,"type":21},"2026-05",{"name":212,"class":76},"Hospital Universitario La Paz",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":221,"sex":17,"minAge":18,"maxAge":196,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":226,"conditions":227,"keywords":228,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":77},"100605340","relief-multimodal-prehabilitation-to-treat-fatigue-in-patients-with-primary-biliary-cholangitis-100605340","NCT07161245","RELIEF: Multimodal Prehabilitation to Treat Fatigue in Patients With Primary Biliary Cholangitis","A Randomized Clinical Trial on the Improvement of Fatigue in Patients With Primary Biliary Cholangitis by Implementation of a Multimodal Rehabilitation Program and Study of Its Pathophysiological Mechanisms","RELIEF","Inclusion Criteria:\n\n* Age ≥18 years\n* PBC diagnosis according to EASL guidelines\n* Moderate - severe fatigue defined by ≥ 29 points in PBC-40 questionnaire\n\nExclusion Criteria:\n\n* Age \\> 80 years\n* Severe pruritus\n* Decompensated cirrhosis\n* Other causes of liver disease than PBC\n* Liver transplant (LT) o placement on a waiting-list for LT\n* Uncontrolled thyroid disesase\n* Anemia with haemoglobin \\\u003C11g\u002Fdl\n* Uncontrolled cardiovascular risk factors\n* BMI \\> 35,\n* Acute myocardial infarct or unstable angina the past 6 months\n* Muscle disease or systemic disease with potential muscle involvement\n* Dysautonomy\n* Untreated osteoporosis\n* Untreated celiac disease\n* Alcohol consumption \\> 14 standard drinks (SD) in women and \\>21 (SD) in men per week\n* Chronic kidney disease ≥ 4 KDIGO stage\n* Malignancy in the past two years (except for non melanoma skin cancer and in situ cervical carcinoma)\n* Not capable of performing or following the prehabilitation program\n* Involvement in a clinical trial the previous 2 months\n* Refusal of informed consent\n\nFor the study of the pathophysiology of fatigue, additional exclusion criteria will be established: Severe depression or neuropsychiatric disease, 2) Treatment with centrally acting drugs, 3) Muscular or systemic disease with potential muscle involvement, 4) Immunosuppressive treatment, 5) Sleep disorder, 6) Obesity (BMI \\>30).",true,{"count":223,"type":21},64,[225],"NA","The implementation of a non-pharmacological multimodal intervention program-including physical exercise, nutritional counseling, and psychological support-is expected to improve fatigue in patients with primary biliary cholangitis. Consequently, this improvement is anticipated to enhance quality of life and cognitive symptoms, while also positively impacting emotional, social, and occupational aspects.\n\nFrom a pathophysiological perspective, it is hypothesized that chronic cholestasis and\u002For immune system activation, with the release of pro-inflammatory cytokines, leads to both central and peripheral alterations causing fatigue.\n\nAt the central level, systemic inflammation may induce neuronal senescence in the basal ganglia, resulting in altered functional connectivity networks dependent on these regions and\u002For structural and connectivity changes in areas involved in interoception, such as the insula and anterior cingulate cortex.\n\nAt the peripheral level, the hypothesis is that chronic inflammation mediated by anti-mitochondrial antibodies causes mitochondrial metabolic dysfunction in muscle cells, which would be reflected in changes observed in the gene expression analysis of these cells.\n\nImprovement in fatigue following the multimodal intervention program is expected to be associated with normalization of the immunological profile, enhanced functional brain connectivity, and improved mitochondrial metabolism in muscle.",[27],[229,230,231,232,233,234],"FATIGUE","PREHABILITATION","PHYSICAL ACTIVITY","MINDFULNESS MEDITATION","NUTRITION","QUALITY OF LIFE","2025-09-01",{"date":237,"type":32},"2025-09-08",{"date":239,"type":32},"2025-02-06",{"date":241,"type":21},"2026-12-31",{"name":243,"class":76},"Hospital Clinic of Barcelona",{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":251,"targetDuration":253,"studyType":115,"phases":4,"briefSummary":254,"conditions":255,"keywords":259,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":77},"100604450","pbc-long-term-outcomes-study-100604450","NCT07149675","PBC Long-term Outcomes Study","A Multi-center Prospective-retrospective Study of the Clinical Characteristics, Biochemical Response, and Long-term Outcomes in Patients With Primary Biliary Cholangitis","Inclusion Criteria:\n\n* Diagnosis consistent with PBC.\n* Willingness to participate, with informed consent obtained from the patient or legal representative (if the patient is deceased or cognitively impaired), and ability to adhere to follow-up.\n\nExclusion Criteria:\n\n* Co-existing chronic hepatitis B or C, drug-induced liver injury, autoimmune hepatitis, primary sclerosing cholangitis, or hereditary\u002Fmetabolic liver diseases.\n* Co-existingMalignancy or severe cardiac, pulmonary, renal, cerebral, or hematologic disorders expected to substantially shorten life expectancy.\n* Incomplete baseline medical records or laboratory data.",{"count":252,"type":21},4000,"3 Years","Primary biliary cholangitis (PBC) is an autoimmune liver disease predominantly affecting middle-aged women. While historically it was deemed rare, advancements in specific auto-antibody tests have led to increased recognition of PBC. The long-term survival of PBC patients in China is not yet fully understood. Several studies have investigated the prognosis of PBC in China. While these studies provide valuable insights into the disease characteristics and prognostic factors of PBC in China, they are all single-center studies with limitations. They lack consideration of the impact of symptoms, varying disease stages, and second-line treatments on prognosis. Therefore, there is a pressing need for multicenter and large-scale studies to further elucidate the characteristics and long-term survival of PBC patients in China.\n\nBiochemical response to ursodeoxycholic acid (UDCA) is an independent factor associated with long-term survival. Unfortunately, approximately 30-40% of PBC patients demonstrate insufficient biochemical response to UDCA. In our cohort, we reported a higher nonresponse rate, with about 44% according to the Paris I criteria. These patients remain at risk for disease progression to advanced stages and may benefit from additional second-line drug therapies. With significant advancements in the development of new drugs for PBC, a comprehensive understanding of patients with suboptimal responses to UDCA-including long-term prognosis, the distribution of different disease stages, and the prevalence of pruritus-will provide a basis for individualized treatment strategies.\n\nAdditionally, fatigue and pruritus are prevalent symptoms for PBC patients and fluctuates independently of disease activity or stage, which significantly diminishing health-related quality of life. However, the incidence and impact of fatigue and pruritus on long-term outcomes for PBC patients in China need further clarification.\n\nTherefore, we would like to conduct this multicenter study to estimate the prevalence of PBC in China and to evaluate the symptomatic burden, treatment, and long-term outcomes among PBC patients in China.",[27,256,257,258],"Long-term Outcomes","Prognosis","Multicenter Prospective Study",[260,261,262,263,264],"Primary biliary cholangitis","long-term outcomes","prognosis","multicenter","Symptoms","2025-08-24",{"date":267,"type":32},"2025-09-02",{"date":269,"type":32},"2025-05-18",{"date":271,"type":21},"2029-12-31",{"name":273,"class":76},"Beijing Friendship Hospital",{"id":275,"slug":276,"hasResults":11,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":281,"targetDuration":4,"studyType":22,"phases":283,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":77},"100600954","early-phase-1-fenofibrate-in-subjects-with-primary-biliary-cholangitis-pbc-100600954","NCT07104201","Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)","An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)","Inclusion Criteria:\n\n1. Must have given written informed consent (signed and dated)\n2. Completed in a PBC study with fenofibrate(NCT06591455)\n3. 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\n1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar\n2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results",{"count":282,"type":21},15,[284],"EARLY_PHASE1","An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)",[27],"2025-08-03",{"date":289,"type":32},"2025-08-05",{"date":291,"type":32},"2025-03-13",{"date":293,"type":21},"2035-03",{"name":154,"class":76},{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":303,"targetDuration":305,"studyType":115,"phases":4,"briefSummary":306,"conditions":307,"keywords":310,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":77},"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":304,"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.",[308,27,55,309],"Hepatitis Autoimmune Disease","Cholestatic Genetic Diseases",[309,55,308,27,311,312,313,314,315,316,317,318,319,320,321,322],"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":325,"type":32},"2025-01-10",{"date":327,"type":32},"2016-01-01",{"date":329,"type":21},"2030-12",{"name":331,"class":76},"Asociación Española para el Estudio del Hígado"]