Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome

ClinicalTrials.gov ID: NCT05035030

Public ClinicalTrials.gov record NCT05035030. 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.

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ClinicalTrials.gov public records Last synced May 19, 2026, 8:11 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT-EXT)

Study identification

NCT ID: NCT05035030
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Albireo, an Ipsen Company; Industry
Enrollment: 70 participants

Conditions and interventions

Conditions

Alagille Syndrome

Interventions

Odevixibat Drug

Drug

Eligibility (public fields only)

Age range: Not listed
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: Sep 2, 2021
Primary completion: Dec 30, 2026
Completion: Dec 30, 2026
Last update posted: Apr 29, 2026

2021 – 2026

United States locations

U.S. sites: 18
U.S. states: 12
U.S. cities: 17

Facility	City	State	ZIP	Site status
Rady Children's Hospital	San Diego	California	92123	Recruiting
UCSF	San Francisco	California	94158	Recruiting
Children's Healthcare of Atlanta	Atlanta	Georgia	30329	Recruiting
Riley Hospital for Children at IU Health	Indianapolis	Indiana	46202	Recruiting
Johns Hopkins Hospital	Baltimore	Maryland	21287	Recruiting
Boston Children's Hospital	Boston	Massachusetts	02115	Completed
Children's Mercy Hospital and Clinics	Kansas City	Missouri	64018	Recruiting
Northwell Health System	New Hyde Park	New York	11042	Recruiting
Hassenfeld Children's Hospital at NYU Langone	New York	New York	10016	Recruiting
New York-Presbyterian / Columbia University Irving Medical Center	New York	New York	10032	Not yet recruiting
The Childrens Hospital at Montefiore Albert Einstein School of Medicine	The Bronx	New York	10467	Completed
Atrium Health Carolinas Medical	Durham	North Carolina	27710	Recruiting
Cincinnati Children's Hospital	Cincinnati	Ohio	45229	Recruiting
Oregon Health Science University School of Medicine	Portland	Oregon	97239	Recruiting
Monroe Carell Jr. Childrens Hospital at Vanderbilt	Nashville	Tennessee	37232	Recruiting
Childrens Medical Center of Dallas University of Texas Southwestern	Dallas	Texas	75207	Recruiting
Texas Children's Hospital	Houston	Texas	77030	Recruiting
Texas Liver Institute	San Antonio	Texas	78215	Recruiting

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 21 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05035030, 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 Apr 29, 2026 · Synced May 19, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05035030 live on ClinicalTrials.gov.

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