6 unknown, 3 completed, 3 terminated, 2 active not recruiting. 18 Phase 3, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 18 | Unknown 6, Completed 3, Terminated 3, Active not recruiting 2, Withdrawn 2, Not yet recruiting 1, Recruiting 1 |
| Phase 2 | 4 | Terminated 2, Completed 1, Withdrawn 1 |
Follow Cholangitis: new trials by email Literature Review of Cholangitis trials Research Report on 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 |
|---|---|---|---|---|---|---|
| A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis Elafibranor, Placebo - Primary Sclerosing Cholangitis | Phase 3 | Recruiting | Ipsen | 350 | 2026-05-14 | 2026-10-23 |
| Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC) norucholic acid - Primary Sclerosing Cholangitis | Phase 3 | Not yet recruiting | Dr. Falk Pharma GmbH | 120 | 2025-03-01 | 2025-03-20 |
| A Multi-center Evaluation of Aldafermin in a Randomized, Double-blind, Placebo-controlled Study in Subjects With Primary Sclerosing Cholangitis. aldafermin, Placebo - Primary Sclerosing Cholangitis | Phase 2 / Phase 3 | Withdrawn | NGM Biopharmaceuticals, Inc | 2024-10-21 | 2025-05-07 | |
| Evaluation of Maralixibat in Pruritus Associated With General Cholestatic Liver Disease (EXPAND) Maralixibat, Placebo - Cholestatic Liver Disease (Except ALGS, PFIC, PBC and PSC) | Phase 3 | Active not recruiting | Mirum Pharmaceuticals, Inc. | 90 | 2024-10-14 | 2026-11-13 |
| The Effects of Bromelain Supplement in Patients With Ulcerative Colitis Bromlein, Placebo - Ulcerative Colitis, Primary Sclerosing Cholangitis | Phase 2 / Phase 3 | Completed | National Nutrition and Food Technology Institute | 52 | 2024-04-20 | 2026-10-27 |
| Efficacy of 24 Month of Bezafibrate in Primary Sclerosing Cholangitis With Persistent Cholestasis Despite Ursodeoxycholic Acid Therapy Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy, Placebo of Bezafibrate in addition to standard UDCA therapy - Primary Sclerosing Cholangitis, Cholestasis | Phase 3 | Unknown | Assistance Publique - Hôpitaux de Paris | 104 | 2021-04-06 | 2022-05-10 |
| Effect of Simvastatin on the Prognosis of Primary Primary Sclerosing Cholangitis (PSC) Simvastatin 40mg, Placebo oral tablet - Primary Sclerosing Cholangitis | Phase 3 | Active not recruiting | Annika Bergquist | 571 | 2020-10-01 | 2025-09-05 |
| Vancomycin for Primary Sclerosing Cholangitis Vancomycin, Placebo - Primary Sclerosing Cholangitis | Phase 2 / Phase 3 | Terminated | Elizabeth Carey | 102 | 2020-01-23 | 2026-10-21 |
| Study of Cilofexor in Adults With Primary Sclerosing Cholangitis Cilofexor, Placebo - Primary Sclerosing Cholangitis | Phase 3 | Terminated | Gilead Sciences | 419 | 2019-03-27 | 2023-11-29 |
| Kaffes Stent in the Management of Post-surgical Biliary Strictures Metallic stent, Multiple plastic stents - Benign Biliary Stricture, Biliary Stricture | Phase 3 | Unknown | Cairo University | 30 | 2018-07-01 | 2020-03-17 |
| norUrsodeoxycholic Acid vs Placebo in PSC norUrsodeoxycholic Acid - Primary Sclerosing Cholangitis | Phase 3 | Unknown | Dr. Falk Pharma GmbH | 303 | 2018-02-08 | 2024-08-06 |
| Efficacy and Safety of Vedolizumab Intravenous (IV) in the Treatment of Primary Sclerosing Cholangitis in Subjects With Underlying Inflammatory Bowel Disease Vedolizumab, Placebo - Primary Sclerosing Cholangitis, Inflammatory Bowel Disease | Phase 3 | Withdrawn | Takeda | 2017-02-01 | 2017-03-08 | |
| The Effect of Bezafibrate on Cholestatic Itch Bezafibrate, Placebo - Primary Biliary Cholangitis, Primary Sclerosing Cholangitis | Phase 3 | Unknown | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | 84 | 2016-02-01 | 2016-03-08 |
| Digital SpyGlass Confirmed Common Bile Duct Stones Clearance Without Fluoroscopy Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS) - Common Bile Duct Diseases, Stone - Biliary | Phase 3 | Completed | Chulalongkorn University | 51 | 2015-12-01 | 2016-11-18 |
| Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects Oral Vancomycin - Primary Sclerosing Cholangitis | Phase 3 | Completed | Stanford University | 34 | 2012-01-01 | 2018-09-21 |
| Short-term Stenting Versus Balloon Dilatation for Dominant Strictures in Primary Sclerosing Cholangitis plastic endoprosthesis, balloon dilatation - Primary Sclerosing Cholangitis | Phase 3 | Unknown | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | 100 | 2011-05-01 | 2012-07-09 |
| Probiotics in Patients With Primary Sclerosing Cholangitis Probiotics - Primary Sclerosing Cholangitis | Phase 3 | Unknown | UMC Utrecht | 12 | 2005-01-01 | 2007-01-09 |
| Trial of High-dose Urso in Primary Sclerosing Cholangitis Ursodeoxycholic Acid, Placebo - Primary Sclerosing Cholangitis | Phase 2 / Phase 3 | Terminated | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 150 | 2002-07-01 | 2021-05-03 |
Cholangitis, Sclerosing (17) · Pruritus (3) · Cholestasis (2) · Biliary Atresia (1) · Bites and Stings (1) · Cholecystolithiasis (1) · Colitis, Ulcerative (1) · Common Bile Duct Diseases (1) · Gallstones (1) · Inflammatory Bowel Diseases (1) · Liver Cirrhosis, Biliary (1)
Bile Duct Diseases (18) · Biliary Tract Diseases (18) · Digestive System Diseases (18) · Pathological Conditions, Signs and Symptoms (4) · Signs and Symptoms (3) · Skin Diseases (3) · Skin Manifestations (3) · Skin and Connective Tissue Diseases (3) · Gastroenteritis (2) · Gastrointestinal Diseases (2) · Intestinal Diseases (2) · Calculi (1) · Chemically-Induced Disorders (1) · Cholelithiasis (1)
Bezafibrate (2) · Vancomycin (2) · 2-(2,6-dimethyl-4-(3-(4-(methylthio)phenyl)-3-oxo-1-propenyl)phenoxyl)-2-methylpropanoic acid (1) · 24-norursodeoxycholic acid (1) · Probiotics (1) · Self Expandable Metallic Stents (1) · Simvastatin (1) · Ursodeoxycholic Acid (1) · aldafermin (1) · cilofexor (1) · maralixibat (1) · vedolizumab (1)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (2) · Dr. Falk Pharma GmbH (2) · Annika Bergquist (1) · Assistance Publique - Hôpitaux de Paris (1) · Cairo University (1) · Chulalongkorn University (1) · Elizabeth Carey (1) · Gilead Sciences (1) · Ipsen (1) · Mirum Pharmaceuticals, Inc. (1) · NGM Biopharmaceuticals, Inc (1) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (1) · National Nutrition and Food Technology Institute (1) · Stanford University (1) · Takeda (1)
United States (6) · France (4) · Germany (4) · Netherlands (4) · Spain (4) · Austria (3) · Belgium (3) · Canada (3) · Italy (3) · Sweden (3) · United Kingdom (3) · Australia (2) · Brazil (2) · Denmark (2) · Finland (2)
Michael Trauner, MD (2) · Annika Bergquist, MD PhD (1) · Azita Hekmatdoost, MD, PhD (1) · Cyriel Y Ponsioen, dr. (1) · Elizabeth Carey, MD (1) · Kenneth Cox, MD (1)
PMID 19585548, PMID 23054338, PMID 28535810, PMID 29803836, PMID 32633158, PMID 33031833, PMID 38977324, PMID 39601354, PMID 41173015, PMID 42489629
2014 (1), 2018 (1), 2019 (1), R01DK056924 (1)