10 completed. 10 Phase 2, 1 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 10 | Completed 10 |
| Phase 1 | 1 | Completed 1 |
| Phase 3 | 1 | Completed 1 |
Follow Primary Biliary Cholangitis: new trials by email Literature Review of Primary Biliary Cholangitis trials Research Report on Primary Biliary Cholangitis
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 |
|---|---|---|---|---|---|---|
| Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment. K-808 (Dose A), K-808 (Dose B), Placebo - Primary Biliary Cholangitis | Phase 2 | Completed | Kowa Research Institute, Inc. | 46 | 2024-02-07 | 2026-10-07 |
| Study to Evaluate the Safety and Efficacy of ASC42 Tablets in Subjects With Primary Biliary Cholangitis ASC42 5 mg, ASC42 10 mg, ASC42 15 mg - Primary Biliary Cholangitis | Phase 2 | Completed | Gannex Pharma Co., Ltd. | 98 | 2022-04-06 | 2024-09-27 |
| Saroglitazar Magnesium for Treatment of Primary Biliary Cholangitis Saroglitazar Magnesium 1 mg, Saroglitazar Magnesium 2 mg, Placebo - Primary Biliary Cholangitis | Phase 2 / Phase 3 | Completed | Zydus Therapeutics Inc. | 196 | 2022-04-01 | 2026-09-17 |
| Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC Bezafibrate 100 mg, Bezafibrate 200 mg, Obeticholic Acid 5 mg - Primary Biliary Cholangitis | Phase 2 | Completed | Intercept Pharmaceuticals | 72 | 2022-03-21 | 2026-07-16 |
| A Trial of Setanaxib in Patients With Primary Biliary Cholangitis (PBC) and Liver Stiffness Setanaxib, Placebo - Primary Biliary Cholangitis, Liver Stiffness | Phase 2 | Completed | Calliditas Therapeutics Suisse SA | 76 | 2022-02-14 | 2025-04-24 |
| Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary Cholangitis CNP-104, Placebo - Primary Biliary Cholangitis | Phase 1 / Phase 2 | Completed | COUR Pharmaceutical Development Company, Inc. | 42 | 2022-01-25 | 2026-03-10 |
| 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 |
| Combination Antiretroviral Therapy (cART) for PBC Emtricitabine (FTC)/Tenofovir Disoproxil (TDF), Raltegravir, Placebo Oral Capsule [CEBOCAP] - Primary Biliary Cholangitis | Phase 2 | Completed | University of Alberta | 37 | 2021-03-01 | 2024-02-16 |
| A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Primary Biliary Cholangitis EDP-305 1 mg, EDP-305 2.5 mg, Placebo - Primary Biliary Cholangitis | Phase 2 | Completed | Enanta Pharmaceuticals, Inc | 68 | 2017-12-27 | 2021-05-18 |
| A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients Part 1: LJN452, Part 1: Placebo, Part 2: LJN452 Dose level 1 - Primary Biliary Cholangitis | Phase 2 | Completed | Novartis Pharmaceuticals | 61 | 2015-09-09 | 2021-01-05 |
Liver Cirrhosis, Biliary (10) · Biliary Tract Diseases (1) · Cholangitis (1) · Cholestasis (1) · Fibrosis (1)
Bile Duct Diseases (10) · Cholestasis, Intrahepatic (10) · Digestive System Diseases (10) · Liver Cirrhosis (10) · Liver Diseases (10) · Pathologic Processes (10) · Pathological Conditions, Signs and Symptoms (10) · Biliary Tract Diseases (9) · Cholestasis (9) · Fibrosis (9)
(R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid (1) · Bezafibrate (1) · EDP-305 (1) · Emtricitabine (1) · Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination (1) · Raltegravir Potassium (1) · obeticholic acid (1) · saroglitazar (1) · setanaxib (1) · tropifexor (1)
COUR Pharmaceutical Development Company, Inc. (1) · Calliditas Therapeutics Suisse SA (1) · Enanta Pharmaceuticals, Inc (1) · Gannex Pharma Co., Ltd. (1) · HighTide Therapeutics (Hong Kong) Limited (1) · Intercept Pharmaceuticals (1) · Kowa Research Institute, Inc. (1) · Novartis Pharmaceuticals (1) · University of Alberta (1) · Zydus Therapeutics Inc. (1)
United States (8) · Canada (6) · Germany (3) · United Kingdom (3) · Argentina (2) · Australia (2) · Austria (2) · Belgium (2) · France (2) · Italy (2) · Poland (2) · Spain (2) · China (1) · Czechia (1) · Greece (1)
Adrian DiBisceglie, MD (1) · Andre Belous, MD, PhD (1) · Andrew Mason, MD (1) · Christopher Bowlus, MD (1) · Deven V Parmar, MD (1) · Lynda Szczech, M.D. (1)
2015 (1)