Trials / Active Not Recruiting
Active Not RecruitingNCT04336722
Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 254 (actual)
- Sponsor
- Albireo, an Ipsen Company · Industry
- Sex
- All
- Age
- 111 Days
- Healthy volunteers
- Not accepted
Summary
Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in children with biliary atresia who have undergone a Kasai hepatoportoenterostomy.
Detailed description
Up to 70 sites will be initiated for this study in North America, Europe, Middle East, and Asia Pacific.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Odevixibat | Odevixibat is a small molecule and selective inhibitor of IBAT. |
| DRUG | Placebo | Placebo identical in appearance to experimental drug (odevixibat). |
Timeline
- Start date
- 2020-07-08
- Primary completion
- 2026-06-26
- Completion
- 2026-06-26
- First posted
- 2020-04-07
- Last updated
- 2026-04-01
Locations
72 sites across 19 countries: United States, Australia, Belgium, Canada, China, France, Germany, Hungary, Israel, Italy, Malaysia, Netherlands, New Zealand, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04336722. Inclusion in this directory is not an endorsement.