16 completed. 16 Phase 2, 2 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 16 | Completed 16 |
| Phase 1 | 2 | Completed 2 |
| Phase 3 | 1 | Completed 1 |
Follow Primary Biliary Cirrhosis: new trials by email Literature Review of Primary Biliary Cirrhosis trials Research Report on Primary Biliary Cirrhosis
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Open-Label Study of HTD1801 in Adult Subjects With Primary Biliary Cholangitis HTD1801 (BUDCA) - Primary Biliary Cholangitis, Primary Biliary Cirrhosis | Phase 2 | Completed | HighTide Therapeutics (Hong Kong) Limited | 24 | 2021-05-27 | 2026-08-25 |
| Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation for Children Suffering From Biliary Atresia Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation - Primary Biliary Cirrhosis | Phase 1 / Phase 2 | Completed | Vinmec Research Institute of Stem Cell and Gene Technology | 20 | 2019-08-10 | 2024-06-06 |
| Study to Evaluate Safety, Tolerability and Efficacy of Saroglitazar Mg in Patients With Primary Biliary Cholangitis Saroglitazar magnesium 2 mg, Saroglitazar magnesium 4 mg, Placebo Oral Tablet - Primary Biliary Cirrhosis | Phase 2 | Completed | Zydus Therapeutics Inc. | 37 | 2017-08-18 | 2024-09-19 |
| Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol. GKT137831, Placebo oral capsule - Primary Biliary Cirrhosis | Phase 2 | Completed | Calliditas Therapeutics AB | 111 | 2017-06-26 | 2022-06-29 |
| Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC) MBX-8025 2 mg Capsule, MBX-8025 5 mg Capsule, MBX-8025 10 mg Capsule - Primary Biliary Cirrhosis | Phase 2 | Completed | Gilead Sciences | 119 | 2016-11-28 | 2022-07-14 |
| Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis NGM282 - Primary Biliary Cirrhosis | Phase 2 | Completed | NGM Biopharmaceuticals, Inc | 36 | 2014-05-01 | 2017-03-28 |
| Phase 2 Study of NGM282 in Patients With Primary Biliary Cirrhosis NGM282, Placebo - Primary Biliary Cirrhosis | Phase 2 | Completed | NGM Biopharmaceuticals, Inc | 45 | 2014-02-01 | 2017-03-28 |
| Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis Obeticholic Acid - Primary Biliary Cirrhosis | Phase 2 | Completed | Intercept Pharmaceuticals | 27 | 2013-12-03 | 2022-08-24 |
| Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis LUM001, Placebo, Ursodeoxycholic Acid - PBC, Primary Biliary Cirrhosis | Phase 2 | Completed | Mirum Pharmaceuticals, Inc. | 66 | 2013-08-01 | 2019-03-27 |
| B-Cell Depleting Therapy (Rituximab) as a Treatment for Fatigue in Primary Biliary Cirrhosis Rituximab, Placebo - Fatigue, Primary Biliary Cirrhosis | Phase 2 | Completed | Newcastle-upon-Tyne Hospitals NHS Trust | 71 | 2012-10-01 | 2017-01-13 |
| A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid ustekinumab 90 mg, ustekinumab 45 mg, ustekinumab 180 mg - Primary Biliary Cirrhosis | Phase 2 | Completed | Janssen Research & Development, LLC | 20 | 2011-09-01 | 2016-06-20 |
| Pentoxifylline for Primary Biliary Cirrhosis Pentoxifylline - Primary Biliary Cirrhosis | Phase 2 | Completed | The Cleveland Clinic | 20 | 2010-11-01 | 2013-12-09 |
| Use of Fenofibrate for Primary Biliary Cirrhosis Fenofibrate IDD-P (Insoluble Drug Delivery-Micro Particle) - Primary Biliary Cirrhosis | Phase 2 | Completed | University of Florida | 20 | 2007-08-01 | 2018-03-08 |
| Initial Study of Rituximab to Treat Primary Biliary Cirrhosis rituximab - Primary Biliary Cirrhosis | Phase 1 / Phase 2 | Completed | University of California, Davis | 6 | 2007-01-01 | 2017-07-02 |
| Study of Combivir for Patients With Primary Biliary Cirrhosis Combination antiviral therapy, Placebo - Primary Biliary Cirrhosis | Phase 2 / Phase 3 | Completed | University of Alberta | 59 | 2004-01-01 | 2007-11-01 |
| Moexipril for Primary Biliary Cirrhosis Moexipril - Primary Biliary Cirrhosis | Phase 2 | Completed | Mayo Clinic | 20 | 2003-06-01 | 2011-05-23 |
Liver Cirrhosis, Biliary (16) · Biliary Atresia (1) · Biliary Tract Diseases (1) · Cholangitis (1) · Cholestasis (1) · Fatigue (1) · Liver Cirrhosis (1)
Bile Duct Diseases (16) · Cholestasis, Intrahepatic (16) · Digestive System Diseases (16) · Fibrosis (16) · Liver Diseases (16) · Pathologic Processes (16) · Pathological Conditions, Signs and Symptoms (16) · Biliary Tract Diseases (15) · Cholestasis (15) · Liver Cirrhosis (15) · Congenital Abnormalities (1) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (1) · Digestive System Abnormalities (1) · Signs and Symptoms (1)
Rituximab (2) · aldafermin (2) · (2-methyl-4-(5-methyl-2-(4-trifluoromethyl-phenyl)-2H-(1,2,3)triazol-4-ylmethylsulfanyl)phenoxy)acetic acid (1) · Pentoxifylline (1) · Transplantation (1) · Ursodeoxycholic Acid (1) · Ustekinumab (1) · lamivudine, zidovudine drug combination (1) · moexipril (1) · obeticholic acid (1) · saroglitazar (1) · seladelpar (1) · setanaxib (1)
NGM Biopharmaceuticals, Inc (2) · Calliditas Therapeutics AB (1) · Gilead Sciences (1) · HighTide Therapeutics (Hong Kong) Limited (1) · Intercept Pharmaceuticals (1) · Janssen Research & Development, LLC (1) · Mayo Clinic (1) · Mirum Pharmaceuticals, Inc. (1) · Newcastle-upon-Tyne Hospitals NHS Trust (1) · The Cleveland Clinic (1) · University of Alberta (1) · University of California, Davis (1) · University of Florida (1) · Vinmec Research Institute of Stem Cell and Gene Technology (1) · Zydus Therapeutics Inc. (1)
United States (14) · Canada (5) · United Kingdom (5) · Australia (2) · Germany (2) · Belgium (1) · Greece (1) · Israel (1) · Italy (1) · New Zealand (1) · Spain (1) · Vietnam (1)
Stephen J Rossi, PharmD (2) · Adrian DiBisceglie, MD (1) · Andrew L Mason, MBBS MRCPI (1) · Bruce Bacon, MD (1) · Catherine Vincent, MD FRCPC (1) · Christopher L Bowlus, MD (1) · Claudia O. Zein, MD, MSc (1) · Cynthia Levy, MD (1) · David EJ Jones, BA, BM, MRCP, PhD, FRCP (1) · Deven Parmar, MD FACP FCP (1) · George Harb, MD (1) · James Neuberger, MD FRCP (1) · Keith D Lindor, MD (1) · Keith Lindor, MD (1)
PMID 21083674, PMID 25543678, PMID 29790196, PMID 33769355, PMID 34487750, PMID 35367282, PMID 36809195, PMID 37183520, PMID 40907882
2016 (1)