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NCT04336722 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
A Phase 3 study of Biliary Atresia, sponsored by Albireo, an Ipsen Company.
- Active
- Registry status
- Phase 3
- Development phase
- 254
- Enrollment target
- 20
- Study locations
NCT04336722: Active Phase 3 study of Biliary Atresia, sponsored by Albireo, an Ipsen Company.
NCT04336722 is a Phase 3 study of Biliary Atresia that is active but no longer recruiting, run by Albireo, an Ipsen Company. The registered enrollment target is 254 participants, below the 539-participant average among 7 other Biliary Atresia trials with a reported enrollment target (53% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04336722, a Phase 3 study of Biliary Atresia, is active but no longer recruiting, sponsored by Albireo, an Ipsen Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 254 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Odevixibat
Study Locations (20)
California
- Children's Hospital Los Angeles - Los Angeles
- Stanford Children's Health - Palo Alto
- Rady Children's Hospital - San Diego
- UCSF Benioff Children's Hospital San Francisco - San Francisco
New York
- NYU Grossman school of Medicine - New York
- Icahn School of Medicine at Mount Sinai - New York
- NewYork-Presbyterian Morgan Stanley Children's Hospital - New York
- The Children's Hospital at Montefiore - The Bronx
Missouri
- Children's Mercy Hospital - Kansas City
- Washington University in St. Louis - St Louis
Colorado
- Children's Hospital Colorado - Aurora
Delaware
- Nemours/Alfred I. duPont Hospital for Children - Wilmington
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- University of Miami - Miami
Georgia
- Children's Healthcare of Atlanta - Emory University School of Medicine - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 254 participants |
| Start Date | 2020-07-08 |
| Est. Completion | 2026-06-26 |
| Phase | Phase 3 |
What the registry record for NCT04336722 still lists
NCT04336722 is an interventional study that assigns participants to a tested intervention. The registered 254 participants enrollment target is mid-sized for trials with a published cap, below the 539-participant average among 7 other Biliary Atresia trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Biliary Atresia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04336722 names 20 study sites across 13 states, led by California, New York, Missouri.
Frequently Asked Questions
What is clinical trial NCT04336722 about?
NCT04336722 is a clinical study titled "Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)". 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.
What is the current status of trial NCT04336722?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 254 participants. The study started on 2020-07-08. Estimated completion is 2026-06-26.
What conditions does trial NCT04336722 study?
This clinical trial studies the following conditions: Biliary Atresia.
What interventions are being tested in trial NCT04336722?
The interventions under investigation include: Placebo (DRUG), Odevixibat (DRUG).
Who is sponsoring clinical trial NCT04336722?
This trial is sponsored by Albireo, an Ipsen Company, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04336722 being conducted?
This trial has 20 study locations across California, Colorado, Delaware, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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