4 completed, 2 active not recruiting, 1 no longer available. 6 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 4, Active not recruiting 2 |
Follow odevixibat: new trials by email Literature Review of odevixibat trials Research Report on odevixibat
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 |
|---|---|---|---|---|---|---|
| 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 |
| Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome Odevixibat - Alagille Syndrome | Phase 3 | Active not recruiting | Albireo, an Ipsen Company | 62 | 2021-09-03 | 2026-10-23 |
| Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome Odevixibat, Placebo - Alagille Syndrome | Phase 3 | Completed | Albireo | 52 | 2021-03-19 | 2023-11-02 |
| 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 |
| Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC A4250 (odevixibat) - Progressive Familial Intrahepatic Cholestasis | Phase 3 | Completed | Albireo, an Ipsen Company | 116 | 2018-09-28 | 2026-10-21 |
| This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2 A4250 (odevixibat), Placebo - PFIC1, PFIC2 | Phase 3 | Completed | Albireo | 62 | 2018-05-16 | 2025-11-28 |
| Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis Odevixibat - Progressive Familial Intrahepatic Cholestasis | No longer available | Albireo | 2026-07-23 |
Cholestasis (3) · Alagille Syndrome (2) · Biliary Atresia (2) · Cholestasis, progressive familial intrahepatic 1 (2)
Albireo, an Ipsen Company (4) · Albireo (3)
United States (7) · France (6) · Germany (6) · Italy (6) · Netherlands (6) · Poland (6) · Turkey (Türkiye) (6) · Belgium (5) · Canada (5) · United Kingdom (5) · Australia (4) · Israel (4) · Malaysia (4) · Spain (4) · New Zealand (3)
PMID 35780807, PMID 36066745, PMID 37456676, PMID 38670135
2017 (1), 2019 (1), 2023 (1)