Efficacy and Safety of Odevixibat in Children With Biliary Atresia Who Have Undergone a Kasai HPE (BOLD)
Public ClinicalTrials.gov record NCT04336722. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04336722
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 254 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 111 Days
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 8, 2020 (Actual)
- Primary completion
- Jun 22, 2026 (Actual)
- Completion
- Jun 22, 2026 (Actual)
- Last update posted
- Jul 2, 2026
2020 – 2026
United States locations
- U.S. sites
- 30
- U.S. states
- 21
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Stanford Children's Health | Palo Alto | California | 94304 | — |
| Rady Children's Hospital | San Diego | California | 92123 | — |
| UCSF Benioff Children's Hospital San Francisco | San Francisco | California | 94158 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Nemours/Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| University of Miami | Miami | Florida | 33146 | — |
| Children's Healthcare of Atlanta - Emory University School of Medicine | Atlanta | Georgia | 30322 | — |
| Ann & Robert H. Lurie Children's Hospital | Chicago | Illinois | 60611 | — |
| Indiana University school of Medicine | Indianapolis | Indiana | 46202 | — |
| Johns Hopkins Children's Center | Baltimore | Maryland | 21287 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan Children's Hospital | Ann Arbor | Michigan | 48109 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Washington University in St. Louis | St Louis | Missouri | 63110 | — |
| NYU Grossman school of Medicine | New York | New York | 10016 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| NewYork-Presbyterian Morgan Stanley Children's Hospital | New York | New York | 10032 | — |
| The Children's Hospital at Montefiore | The Bronx | New York | 10467 | — |
| Duke Central Tower | Durham | North Carolina | 27710 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| The Children´s Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| UPMC Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania | 15224 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| University of Utah | Salt Lake City | Utah | 84113 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 42 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04336722, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 2, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04336722 live on ClinicalTrials.gov.