25 completed, 3 unknown, 2 not yet recruiting, 2 terminated. 35 Phase 1, 11 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 35 | Completed 25, Unknown 3, Not yet recruiting 2, Terminated 2, Withdrawn 2, Recruiting 1 |
| Phase 2 | 11 | Completed 6, Unknown 2, Not yet recruiting 1, Terminated 1, Withdrawn 1 |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 |
|---|---|---|---|---|---|---|
| Tolerability of Enteral NAC in Infants N-Acetylcysteine - Biliary Atresia | Phase 1 | Not yet recruiting | Sanjiv Harpavat | 12 | 2026-10-01 | 2026-03-04 |
| 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 |
| Evaluate PK & Safety of Saroglitazar in Subjects With Moderate Hepatic Impairment Due to Cholestatic Liver Disease Saroglitazar Magnesium 1 mg - Cholestatic Liver Disease | Phase 1 | Recruiting | Zydus Therapeutics Inc. | 6 | 2025-08-05 | 2026-09-14 |
| A Study of the Pharmacokinetics and Safety of CS0159 in Subjects With Hepatic Injury CS0159 - Primary Biliary Cholangitis | Phase 1 | Completed | Cascade Pharmaceuticals, Inc | 24 | 2025-03-13 | 2025-07-11 |
| Single Ascending Dose Study to Evaluate Safety Tolerability, Pharmacokinetics, and Pharmacodynamics of PVT201 in Healthy Subjects and Patients (PBC/PSC) PVT201, Placebo - Primary Biliary Cholangitis (PBC) | Phase 1 | Completed | Parvus Therapeutics, Inc. | 24 | 2024-10-15 | 2025-11-24 |
| A Study to Evaluate the Pharmacokinetics and Safety of K-808 (Pemafibrate) in Subjects With Primary Biliary Cholangitis With Compensated Cirrhosis and Without Cirrhosis. K-808 - Primary Biliary Cholangitis, Compensated Cirrhosis | Phase 1 | Completed | Kowa Research Institute, Inc. | 17 | 2024-10-01 | 2025-05-23 |
| Study of [14C]CS0159 in China Healthy Subjects [14C]CS0159 - Primary Biliary Cholangitis | Phase 1 | Completed | Cascade Pharmaceuticals, Inc | 6 | 2023-10-23 | 2023-11-21 |
| 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 |
| Study to Evaluate Safety, Tolerability and Pharmacokinetics of CS0159 in Chinese Healthy Subjects CS0159, Placebo - Primary Biliary Cholangitis | Phase 1 | Completed | Cascade Pharmaceuticals, Inc | 36 | 2022-12-19 | 2023-05-03 |
| Phase I Study of Linerixibat in Adults With Moderate Hepatic Impairment and Healthy Controls Linerixibat - Pruritus | Phase 1 | Completed | GlaxoSmithKline | 8 | 2022-07-19 | 2023-01-18 |
| 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 |
| An Open-Label Study Following Oral Dosing of Seladelpar to Participants With Primary Biliary Cholangitis (PBC) and Hepatic Impairment (HI) Seladelpar - Primary Biliary Cholangitis, Compensated Cirrhosis | Phase 1 | Completed | Gilead Sciences | 24 | 2021-11-16 | 2026-05-04 |
| Evaluate the Safety, Tolerability, and PK of EP547 in Healthy Subjects and Subjects With Cholestatic or Uremic Pruritus EP547, Placebo - Pruritus, Cholestasis | Phase 1 | Completed | Escient Pharmaceuticals, Inc | 89 | 2020-09-07 | 2025-08-08 |
| Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I) OP-724 - Primary Biliary Cholangitis (PBC), Liver Cirrhosis, Biliary | Phase 1 | Completed | Kiminori Kimura, MD | 7 | 2019-08-29 | 2022-07-07 |
| Linerixibat and Obeticholic Acid Drug Interaction Study in Healthy Subjects GSK2330672 (linerixibat), Obeticholic acid - Cholestasis | Phase 1 | Completed | GlaxoSmithKline | 19 | 2019-08-27 | 2020-07-24 |
| 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 |
| Pharmacokinetics (PKs) and Metabolism of Radiolabelled Linerixibat Linerixibat tablet, [14C]-linerixibat intravenous infusion, Linerixibat oral solution - Cholestasis | Phase 1 | Completed | GlaxoSmithKline | 6 | 2019-07-08 | 2020-06-26 |
| Needle-Knife Fistulotomy Vs. Standard Cannulation Trial Needle Knife Fistulotomy, standard biliary cannulation - Biliary Obstruction Due to Common Bile Duct Stone, Malignant Bile Duct Obstruction | Phase 1 / Phase 2 | Completed | Thomas Jefferson University | 186 | 2019-01-31 | 2024-11-19 |
| An Open Label, Single-dose, Single Period ADME Study of A4250 in Healthy Subjects 3 mg [14C]-A4250 capsule - Orphan Cholestatic Liver Diseases, Progressive Familial Intrahepatic Cholestasis | Phase 1 | Completed | Albireo | 6 | 2017-01-31 | 2024-03-07 |
| Dose-escalation Study of GSK2330672 in Japanese Healthy Male Volunteers GSK2230672, Placebo - Cholestasis | Phase 1 | Completed | GlaxoSmithKline | 16 | 2016-06-01 | 2016-11-09 |
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Liver Cirrhosis, Biliary (26) · Alagille Syndrome (2) · Biliary Atresia (2) · Cholangitis, Sclerosing (2) · Cholestasis, progressive familial intrahepatic 1 (2) · Fatigue (2) · Hyperphagia (2) · Liver Cirrhosis (2) · Pruritus (2) · Enterocolitis, Necrotizing (1) · Fibrosis (1) · Gastrointestinal Diseases (1) · Inflammation (1) · Jaundice (1)
Bile Duct Diseases (35) · Biliary Tract Diseases (35) · Digestive System Diseases (35) · Pathological Conditions, Signs and Symptoms (30) · Pathologic Processes (29) · Cholestasis, Intrahepatic (26) · Liver Diseases (26) · Fibrosis (25) · Liver Cirrhosis (24) · Signs and Symptoms (7) · Congenital Abnormalities (4) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (4) · Skin Manifestations (4) · Abnormalities, Multiple (2)
Ursodeoxycholic Acid (2) · fish oil triglycerides (2) · (R)-2-(3-((benzoxazol-2-yl-d4 (3-(4-methoxyphenoxy-d7)propyl)amino)methyl)phenoxy) butanoic acid (1) · 130-nm albumin-bound paclitaxel (1) · 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 (1) · Acetylcysteine (1) · Albumin-Bound Paclitaxel (1) · Budesonide (1) · Cholestyramine Resin (1) · Congresses as Topic (1) · Fenofibrate (1) · Gemcitabine (1) · ICG 001 (1) · Indocyanine Green (1) · Modafinil (1)
GlaxoSmithKline (4) · Beijing 302 Hospital (3) · Cascade Pharmaceuticals, Inc (3) · Albireo (2) · Arthur J De Lorimier (1) · Boston Children's Hospital (1) · COUR Pharmaceutical Development Company, Inc. (1) · Celgene (1) · Escient Pharmaceuticals, Inc (1) · Fast Forward Pharmaceuticals (1) · Gilead Sciences (1) · Kiminori Kimura, MD (1) · Kowa Research Institute, Inc. (1) · Mayo Clinic (1) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (1)
United States (14) · China (7) · United Kingdom (6) · Japan (3) · Australia (2) · Germany (2) · Spain (2) · Denmark (1) · Greece (1) · Hungary (1) · Italy (1) · Netherlands (1) · New Zealand (1) · Puerto Rico (1) · Serbia (1)
Alfredo Romano, MD (1) · Christopher Bowlus, MD (1) · Christopher L Bowlus, MD (1) · Deng Rong (1) · Deven Parmar (1) · Fengchun Zhang, MD (1) · Fu-Sheng Wang, MD, PhD (1) · Fu-Sheng Wang, professor (1) · Ian J Griffin, MD (1) · Josef Neu, MD (1) · Keith D Lindor, M.D. (1) · Keith D. Lindor (1)
PMID 10102814, PMID 10655252, PMID 21810549, PMID 23770843, PMID 24561556, PMID 24835895, PMID 25329189, PMID 27148676, PMID 28249726, PMID 29859173, PMID 30193962, PMID 32274345, PMID 35119627, PMID 35933430, PMID 36076306, PMID 36442892, PMID 36809835, PMID 38419761, PMID 38780109, PMID 39982546, PMID 40050288, PMID 40341605, PMID 40439725, PMID 40721581, PMID 40907882
2014 (1), 2016 (1), R03DK052344 (1)