50 completed, 16 terminated, 8 unknown, 5 not yet recruiting. 93 Phase 2, 13 Phase 3, 11 Phase 1.
Follow Cholestasis: new trials by email Literature Review of Cholestasis trials Research Report on Cholestasis
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 |
|---|---|---|---|---|---|---|
| Nemolizumab for the Treatment of Moderate to Severe Chronic Hepatic Pruritus Nemolizumab-ilto - Chronic Hepatic Pruritus, Cholestatic Liver Disease | Phase 2 | Not yet recruiting | Mayo Clinic | 15 | 2026-11-01 | 2026-09-28 |
| Study of Seladelpar and Cilofexor in Participants With Primary Biliary Cholangitis Seladelpar, PTM Seladelpar, Cilofexor Dose B - Primary Biliary Cholangitis | Phase 2 | Recruiting | Gilead Sciences | 132 | 2026-10-01 | 2026-10-27 |
| Phase I/II Trial of Human Umbilical Cord Mesenchymal Stromal Cells for UDCA-Refractory Primary Biliary Cholangitis Standard background therapy, Placebo, hUC-MSC Dose Level 1 - Primary Biliary Cholangitis | Phase 1 / Phase 2 | Not yet recruiting | Beijing 302 Hospital | 68 | 2026-08-31 | 2026-08-31 |
| TH104 for the Treatment of Pruritus in Primary Biliary Cholangitis Nalmefene, Placebo - Pruritus, Primary Biliary Cholangitis | Phase 2 | Not yet recruiting | Tharimmune Inc | 40 | 2026-06-01 | 2025-09-09 |
| The Safety and Efficacy of Upadacitinib in Refractory Autoimmune Related Cholangitis and Atopic Dermatitis With Moderate to Severe Itching Upadacitinib 15 MG - Primary Biliary Cholangitis (PBC), Primary Sclerosing Cholangitis (PSC) | Phase 2 | Not yet recruiting | RenJi Hospital | 44 | 2026-06-01 | 2026-07-01 |
| Maralixibat for Intrahepatic Cholestasis of Pregnancy Maralixibat - Intrahepatic Cholestasis of Pregnancy | Phase 2 | Not yet recruiting | Imperial College London | 28 | 2026-04-01 | 2026-02-05 |
| A Study to Assess the Safety and Efficacy of LB-P8 in Patients With PSC LB-P8 low-dose, LB-P8 high-dose, Placebo - Primary Sclerosing Cholangitis (PSC) | Phase 2 | Recruiting | LISCure Biosciences | 87 | 2025-11-01 | 2025-10-24 |
| A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics Prednisone, UDCA (Ursodeoxycholic acid) - Primary Biliary Cholangitis (PBC) | Phase 2 / Phase 3 | Enrolling by invitation | Han Ying | 244 | 2024-10-30 | 2026-10-29 |
| 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 |
| Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis Fenofibrate, Placebo, UDCA - Primary Biliary Cholangitis | Phase 2 / Phase 3 | Active not recruiting | Han Ying | 184 | 2023-08-21 | 2026-10-29 |
| CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis) 2mg CS0159, Placebo - Primary Biliary Cholangitis (PBC) | Phase 2 | Active not recruiting | Cascade Pharmaceuticals, Inc | 75 | 2023-08-07 | 2026-03-13 |
| Comparative Study of REMAXA®, Enteric-coated Tablets and REMAXOL®, Solution for Infusions, in Intrahepatic Cholestasis Remaxa, enteric-coated tablets, Remaxol, Placebo - Cholestasis, Intrahepatic | Phase 2 / Phase 3 | Completed | POLYSAN Scientific & Technological Pharmaceutical Company | 328 | 2023-05-27 | 2025-04-29 |
| 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 golexanolone, Placebo - Primary Biliary Cholangitis (PBC) | Phase 1 / Phase 2 | Completed | Umecrine Cognition AB | 207 | 2023-04-14 | 2026-10-16 |
| Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis Fenofibrate 200mg, Placebo, UDCA - Primary Biliary Cholangitis | Phase 2 / Phase 3 | Recruiting | Xijing Hospital of Digestive Diseases | 104 | 2023-02-17 | 2026-01-08 |
| BSEP Function Rescue During Childhood Inhereditary Cholestatic Diseases 4-Phenylbutyrate - Hereditary Diseases, Cholestasis, Intrahepatic | Phase 2 / Phase 3 | Withdrawn | Children's Hospital of Fudan University | 2023-02-08 | 2023-02-09 | |
| Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary Sclerosing Cholangitis EP547, Placebo - Pruritus | Phase 2 | Completed | Escient Pharmaceuticals, Inc | 62 | 2022-10-06 | 2025-07-31 |
| 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 |
Showing 20 of 93. Sign in to see all of them.
Liver Cirrhosis, Biliary (63) · Pruritus (14) · Alagille Syndrome (6) · Cholangitis, Sclerosing (5) · Cholestasis, Intrahepatic (5) · Cholangitis (4) · Liver Diseases (4) · Short Bowel Syndrome (4) · Bile Duct Diseases (3) · Biliary Tract Diseases (3) · Fatigue (3) · Fibrosis (3) · Hyperphagia (3) · Biliary Atresia (2)
Digestive System Diseases (91) · Bile Duct Diseases (90) · Biliary Tract Diseases (90) · Pathological Conditions, Signs and Symptoms (78) · Liver Diseases (72) · Pathologic Processes (71) · Cholestasis, Intrahepatic (68) · Liver Cirrhosis (61) · Fibrosis (60) · Signs and Symptoms (20) · Skin Manifestations (16) · Skin Diseases (14) · Skin and Connective Tissue Diseases (14) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (12)
Ursodeoxycholic Acid (10) · fish oil triglycerides (8) · maralixibat (6) · Fenofibrate (5) · obeticholic acid (5) · volixibat (3) · (2-methyl-4-(5-methyl-2-(4-trifluoromethyl-phenyl)-2H-(1,2,3)triazol-4-ylmethylsulfanyl)phenoxy)acetic acid (2) · 3-((((3R,5R)-3-butyl-3-ethyl-7-(methyloxy)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,4-benzothiazepin-8-yl)methyl)amino)pentanedioic acid (2) · Bezafibrate (2) · Rituximab (2) · aldafermin (2) · saroglitazar (2) · seladelpar (2) · setanaxib (2) · (R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid (1)
Mirum Pharmaceuticals, Inc. (12) · Intercept Pharmaceuticals (5) · Gilead Sciences (4) · Beijing 302 Hospital (3) · GlaxoSmithKline (2) · Han Ying (2) · Mayo Clinic (2) · NGM Biopharmaceuticals, Inc (2) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (2) · University of Alberta (2) · University of Florida (2) · Vinmec Research Institute of Stem Cell and Gene Technology (2) · Xijing Hospital of Digestive Diseases (2) · Zydus Therapeutics Inc. (2) · Amarnath, Rathna, M.D. (1)
United States (58) · United Kingdom (30) · Canada (23) · Germany (15) · China (13) · France (13) · Spain (13) · Australia (9) · Belgium (9) · Italy (8) · Poland (8) · Netherlands (7) · Israel (6) · Austria (5) · Argentina (4)
Cynthia Levy, MD (2) · Liem Nguyen (2) · Stephen J Rossi, PharmD (2) · Adrian DiBisceglie, MD (1) · Andre Belous, MD, PhD (1) · Andrew L Mason, MBBS MRCPI (1) · Andrew Mason, MD (1) · Arena CT.gov Administrator (1) · Avash J Singh, MD (1) · Bingliang Lin, MD (1) · Bruce Bacon, MD (1)
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