7 completed, 3 terminated, 3 unknown, 1 not yet recruiting. 16 Phase 2, 3 Phase 3, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 16 | Completed 7, Terminated 3, Unknown 3, Not yet recruiting 1, Recruiting 1, Withdrawn 1 |
| Phase 3 | 3 | Completed 2, Not yet recruiting 1 |
| Phase 1 | 2 | Unknown 2 |
Follow Hepatitis, Autoimmune: new trials by email Literature Review of Hepatitis, Autoimmune trials Research Report on Hepatitis, Autoimmune
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 |
|---|---|---|---|---|---|---|
| Belimumab in Autoimmune Hepatitis Belimumab Auto-Injector [Benlysta] - Autoimmune Hepatitis | Phase 2 | Recruiting | University Health Network, Toronto | 48 | 2024-12-11 | 2026-10-22 |
| Induction of Remission in Autoimmune Hepatitis With Azathioprine vs. MMF Mycophenolate Mofetil + Prednisolone Participants will receive mycophenolate mofetil in combination., Azathioprine + Prednisolone - Autoimmune Hepatitis | Phase 2 / Phase 3 | Not yet recruiting | Institute of Liver and Biliary Sciences, India | 108 | 2024-11-01 | 2024-11-07 |
| A Study of Zetomipzomib (KZR-616) in Patients With Autoimmune Hepatitis (PORTOLA) zetomipzomib, placebo, zetomipzomib in open-label extension - Autoimmune Hepatitis | Phase 2 | Completed | Kezar Life Sciences, Inc. | 24 | 2023-05-23 | 2026-01-13 |
| A Study to Evaluate the Efficacy and Safety of HR19042 Capsules in the Treatment of Autoimmune Hepatitis. HR19042 Capsules - Autoimmune Hepatitis | Phase 2 | Completed | Jiangsu HengRui Medicine Co., Ltd. | 69 | 2022-10-06 | 2025-03-24 |
| Effect of RO7049665 on the Time to Relapse Following Steroid Tapering in Participants With Autoimmune Hepatitis (AIH) RO7049665, Placebo - Autoimmune Hepatitis, Autoimmune Chronic Hepatitis | Phase 2 | Terminated | Hoffmann-La Roche | 2 | 2021-04-19 | 2023-09-18 |
| Effect of JKB-122 on Prednisolone and Azathioprine Induced Remission in Autoimmune Hepatitis (AIH) JKB-122, Placebo - Autoimmune Hepatitis | Phase 2 | Unknown | TaiwanJ Pharmaceuticals Co., Ltd | 120 | 2020-11-01 | 2020-09-01 |
| A Phase 2a Study to Evaluate the Safety and Efficacy of Cannabidiol Only as Maintenance Therapy and Steroid Sparing in Patients With Stable Autoimmune Hepatitis Cannabidiol - Autoimmune Hepatitis | Phase 2 | Terminated | Stero Biotechs Ltd. | 2 | 2019-02-07 | 2020-06-16 |
| Phase II AutoImmune Hepatitis Synthetic PreImplantation Factor - Hepatitis, Autoimmune | Phase 2 | Withdrawn | Christopher O'Brien, MD | 2019-01-01 | 2019-01-03 | |
| Selected Mesenchymal Stromal Cells to Reduce Inflammation in Patients With PSC and AIH Orbcel-C - Cholangitis, Sclerosing, Hepatitis, Autoimmune | Phase 1 / Phase 2 | Unknown | University of Birmingham | 18 | 2018-12-07 | 2024-07-11 |
| ADCC Mediated B-Cell dEpletion and BAFF-R Blockade VAY736, Placebo - Autoimmune Hepatitis | Phase 2 / Phase 3 | Completed | Novartis Pharmaceuticals | 68 | 2018-02-15 | 2026-02-19 |
| Liver Test Study of Using JKB-122 in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies JKB-122 - Autoimmune Hepatitis | Phase 2 | Completed | TaiwanJ Pharmaceuticals Co., Ltd | 20 | 2016-04-30 | 2020-07-21 |
| Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases Interleukin 2 - Rheumatoid Arthritis, Ankylosing Spondylitis | Phase 2 | Completed | Assistance Publique - Hôpitaux de Paris | 81 | 2014-01-06 | 2021-07-20 |
| Safety Study of Ornithine Phenylacetate to Treat Patients With Acute Liver Failure/Severe Acute Liver Injury Ornithine Phenylacetate - Acute Liver Failure, Acute Liver Injury | Phase 2 | Completed | William Lee | 47 | 2012-06-01 | 2018-10-30 |
| Umbilical Cord Mesenchymal Stem Cells for Patients With Autoimmune Hepatitis conventional plus UC-MSC treatment, Conventional plus placebo treatment - Autoimmune Hepatitis | Phase 1 / Phase 2 | Unknown | Beijing 302 Hospital | 100 | 2011-10-01 | 2013-05-31 |
| LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis LCP-Tacro (tacrolimus), Azathioprine - Autoimmune Hepatitis | Phase 2 | Terminated | Veloxis Pharmaceuticals | 13 | 2007-12-01 | 2020-03-17 |
| Budesonide 3x3mg/d Versus Prednisone in Active Autoimmune Hepatitis budesonide, prednisone - Autoimmune Hepatitis | Phase 2 / Phase 3 | Completed | Dr. Falk Pharma GmbH | 208 | 2001-03-01 | 2019-05-07 |
Cholangitis, Sclerosing (2) · Aortic Arch Syndromes (1) · Arthritis, Rheumatoid (1) · Behcet Syndrome (1) · Chemical and Drug Induced Liver Injury (1) · Cholangitis (1) · Colitis, Ulcerative (1) · Crohn Disease (1) · Granulomatosis with Polyangiitis (1) · Hepatitis (1) · Hepatitis B (1) · Hepatitis, Chronic (1) · Inflammation (1) · Liver Diseases (1)
Autoimmune Diseases (16) · Digestive System Diseases (16) · Immune System Diseases (16) · Hepatitis (15) · Hepatitis, Chronic (15) · Liver Diseases (15) · Pathologic Processes (3) · Pathological Conditions, Signs and Symptoms (3) · Bile Duct Diseases (2) · Biliary Tract Diseases (2) · Disease Attributes (2) · Ankylosis (1) · Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (1) · Aortic Diseases (1) · Arthritis (1)
Azathioprine (2) · JKB-122 (2) · Prednisone (2) · Budesonide (1) · Cannabidiol (1) · Congresses as Topic (1) · Injections (1) · Interleukin-2 (1) · KZR-616 (1) · Mycophenolic Acid (1) · Prednisolone (1) · Tacrolimus (1) · belimumab (1) · ianalumab (1) · ornithine phenylacetate (1)
TaiwanJ Pharmaceuticals Co., Ltd (2) · Assistance Publique - Hôpitaux de Paris (1) · Beijing 302 Hospital (1) · Christopher O'Brien, MD (1) · Dr. Falk Pharma GmbH (1) · Hoffmann-La Roche (1) · Institute of Liver and Biliary Sciences, India (1) · Jiangsu HengRui Medicine Co., Ltd. (1) · Kezar Life Sciences, Inc. (1) · Novartis Pharmaceuticals (1) · Stero Biotechs Ltd. (1) · University Health Network, Toronto (1) · University of Birmingham (1) · Veloxis Pharmaceuticals (1) · William Lee (1)
United States (5) · Canada (4) · Germany (3) · United Kingdom (3) · China (2) · Argentina (1) · Australia (1) · Belgium (1) · Czechia (1) · France (1) · Israel (1) · Italy (1) · Japan (1) · Netherlands (1) · Portugal (1)
Andrew Mason, MD (1) · Barry G Rosser, MD (1) · Craig Lammert, MD (1) · Elizabeth Carey, MD (1) · Ethan Weinberg, MD (1) · Fu-Sheng Wang, professor (1) · Gerald Y Minuk, M.D. (1) · Gideon Hirschfield, MB BChir, PhD (1) · John M Vierling, MD (1) · John R Lake, MD (1) · Joseph A Odin, MD, PhD (1) · Kevork M Peltekian, MD (1) · Mark G Swain, MD (1)
PMID 35179437, PMID 20600032, PMID 23810723, PMID 23829627, PMID 30472651, PMID 37183883, PMID 37722131
2023 (1), U01DK058369 (1)