5 completed, 3 terminated, 1 recruiting, 1 unknown. 10 Phase 2, 3 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 10 | Completed 5, Terminated 3, Recruiting 1, Unknown 1 |
| Phase 1 | 3 | Completed 2, Recruiting 1 |
| Phase 3 | 1 | Terminated 1 |
Follow Biliary Atresia: new trials by email Literature Review of Biliary Atresia trials Research Report on Biliary Atresia
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 Assess Efficacy, Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Obeticholic Acid (OCA) Compared to Placebo in Pediatric Participants With Biliary Atresia, Post-hepatoportoenterostomy OCA, Matching Placebo - Biliary Atresia | Phase 2 / Phase 3 | Terminated | Intercept Pharmaceuticals | 28 | 2024-09-02 | 2026-07-07 |
| Use of Indocyanine Green (ICG) for the Diagnosis of Biliary Atresia Indocyanine Green (ICG) - Biliary Atresia | Phase 1 / Phase 2 | Recruiting | Boston Children's Hospital | 20 | 2024-08-01 | 2026-04-06 |
| Part II: Granulocyte-Colony Stimulating Factor Adjunct Therapy for Biliary Atresia Filgrastim - Biliary Atresia | Phase 2 | Unknown | Holterman, Ai-Xuan, M.D. | 400 | 2023-09-01 | 2023-09-08 |
| Evaluation of Maralixibat in Biliary Atresia Response Post-Kasai Maralixibat, Placebo - Biliary Atresia | Phase 2 | Completed | Mirum Pharmaceuticals, Inc. | 75 | 2021-07-08 | 2025-03-19 |
| 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 |
| N-Acetylcysteine in Biliary Atresia After Kasai Portoenterostomy N-Acetyl cysteine - Biliary Atresia | Phase 2 | Completed | Baylor College of Medicine | 13 | 2018-05-18 | 2024-03-26 |
| Autologous Bone Marrow Mononuclear Stem Cell for Children Suffering From Liver Cirrhosis Due to Biliary Atresia Autologous BMMC transplantation - Liver Cirrhosis, Biliary | Phase 2 | Completed | Vinmec Research Institute of Stem Cell and Gene Technology | 17 | 2017-01-02 | 2024-06-04 |
| Obeticholic Acid in Pediatric Subjects With Biliary Atresia OCA 0.1mg, OCA 1.5mg, OCA 5mg - Biliary Atresia | Phase 2 | Terminated | Intercept Pharmaceuticals | 7 | 2015-07-01 | 2023-03-28 |
| Safety Study of Intravenous Immunoglobulin (IVIG) Post-Portoenterostomy in Infants With Biliary Atresia Intravenous immunoglobulin (IVIG) - Biliary Atresia | Phase 1 / Phase 2 | Completed | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 30 | 2013-10-01 | 2026-10-01 |
| Pentoxifylline Therapy in Biliary Atresia Pentoxifylline - Biliary Atresia | Phase 2 | Terminated | Baylor College of Medicine | 17 | 2013-02-04 | 2024-01-11 |
Liver Cirrhosis (2) · Liver Cirrhosis, Biliary (2) · Bile Duct Diseases (1) · Biliary Tract Diseases (1) · Congenital Abnormalities (1) · Fibrosis (1)
Congenital, Hereditary, and Neonatal Diseases and Abnormalities (10) · Digestive System Abnormalities (10) · Digestive System Diseases (10) · Bile Duct Diseases (9) · Biliary Tract Diseases (9) · Congenital Abnormalities (9) · Pathologic Processes (3) · Pathological Conditions, Signs and Symptoms (3) · Cholestasis (2) · Cholestasis, Intrahepatic (2) · Fibrosis (2) · Liver Diseases (2)
Acetylcysteine (1) · Filgrastim (1) · Granulocyte Colony-Stimulating Factor (1) · Hizentra (1) · Immunoglobulins, Intravenous (1) · Indocyanine Green (1) · Pentoxifylline (1) · Transplantation (1) · maralixibat (1) · obeticholic acid (1)
Baylor College of Medicine (2) · Intercept Pharmaceuticals (2) · Vinmec Research Institute of Stem Cell and Gene Technology (2) · Boston Children's Hospital (1) · Holterman, Ai-Xuan, M.D. (1) · Mirum Pharmaceuticals, Inc. (1) · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (1)
United States (6) · Vietnam (4) · Canada (2) · China (2) · Germany (2) · Israel (2) · Poland (2) · Singapore (2) · Taiwan (2) · United Kingdom (2) · Australia (1) · Belgium (1) · France (1) · Hong Kong (1) · Italy (1)
Liem Nguyen (2) · Lynda Szczech, MD (2) · Averell Sherker, MD (1) · Ed Doo, MD (1) · Ronald Sokol, MD (1) · Sanjiv Harpavat, MD PhD (1) · Sanjiv Harpavat, MD. PhD (1)
PMID 30664564, PMID 35287722, PMID 35391541, PMID 40489761, PMID 40907882
U01DK062456 (1)