2 active not recruiting, 2 completed, 1 terminated, 1 unknown. 6 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Active not recruiting 2, Completed 2, Terminated 1, Unknown 1 |
| Phase 2 | 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 |
|---|---|---|---|---|---|---|
| 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 | 2026-10-06 |
| 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 |
| Norepinephrine for Prevention of Intraoperative Hypotension in Infants Undergoing Kasai Portoenterostomy Norepinephrine Bitartrate, Placebo - Anesthesia, Pediatrics | Phase 3 | Completed | Kasr El Aini Hospital | 31 | 2022-08-28 | 2024-07-09 |
| An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia Odevixibat - Biliary Atresia | Phase 3 | Active not recruiting | Albireo, an Ipsen Company | 180 | 2022-07-05 | 2026-10-23 |
| Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD) Odevixibat, Placebo - Biliary Atresia | Phase 3 | Completed | Albireo, an Ipsen Company | 254 | 2020-07-08 | 2026-07-02 |
| RCT of Steroids Following Kasai Portoenterostomy for Biliary Atresia. prednisolone, placebo - Biliary Atresia | Phase 3 | Unknown | King's College Hospital NHS Trust | 100 | 2000-01-01 | 2007-10-04 |
Cholangitis, Sclerosing (1) · Hypotension (1) · Pruritus (1)
Bile Duct Diseases (6) · Biliary Tract Diseases (6) · Congenital Abnormalities (6) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (6) · Digestive System Abnormalities (6) · Digestive System Diseases (6) · Cardiovascular Diseases (1) · Cholangitis (1) · Pathological Conditions, Signs and Symptoms (1) · Signs and Symptoms (1) · Skin Diseases (1) · Skin Manifestations (1) · Skin and Connective Tissue Diseases (1) · Vascular Diseases (1)
odevixibat (2) · Norepinephrine (1) · Prednisolone (1) · maralixibat (1)
Albireo, an Ipsen Company (2) · Intercept Pharmaceuticals (1) · Kasr El Aini Hospital (1) · King's College Hospital NHS Trust (1) · Mirum Pharmaceuticals, Inc. (1)
Canada (4) · Australia (3) · China (3) · France (3) · Germany (3) · Italy (3) · Malaysia (3) · New Zealand (3) · Poland (3) · Spain (3) · Turkey (Türkiye) (3) · United Kingdom (3) · United States (3) · Israel (2) · Netherlands (2)
Khaled Sarhan, MD (1) · Lynda Szczech, MD (1) · Mark Davenport, ChM (1)
2019 (1)