Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
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.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the long-term safety and effectiveness of odevixibat in participants with Alagille syndrome (ALGS). The participants of this study will have ALGS a rare genetic disorder that can affect multiple organ systems of the body including the liver, heart, skeleton, eyes and kidneys. Common symptoms, which often develop during the first three months of life, include blockage of the flow of bile from the liver (cholestasis), yellowing of the skin and mucous membranes (jaundice), poor weight gain and growth and severe itching (pruritis). The drug used for the study is odevixibat and was authorized for the treatment of cholestatic pruritus in infants with ALGS over 12 months of age by the United States Food and Drug Administration on 13 June 2023.
Study identification
- NCT ID
- NCT05035030
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 62 participants
Conditions and interventions
Conditions
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
- Aug 30, 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 | — |
| UCSF | San Francisco | California | 94158 | — |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | — |
| Riley Hospital for Children at IU Health | Indianapolis | Indiana | 46202 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Children's Mercy Hospital and Clinics | Kansas City | Missouri | 64018 | — |
| Northwell Health System | New Hyde Park | New York | 11042 | — |
| Hassenfeld Children's Hospital at NYU Langone | New York | New York | 10016 | — |
| New York-Presbyterian / Columbia University Irving Medical Center | New York | New York | 10032 | — |
| The Childrens Hospital at Montefiore Albert Einstein School of Medicine | The Bronx | New York | 10467 | — |
| Atrium Health Carolinas Medical | Durham | North Carolina | 27710 | — |
| Cincinnati Children's Hospital | Cincinnati | Ohio | 45229 | — |
| Oregon Health Science University School of Medicine | Portland | Oregon | 97239 | — |
| Monroe Carell Jr. Childrens Hospital at Vanderbilt | Nashville | Tennessee | 37232 | — |
| Childrens Medical Center of Dallas University of Texas Southwestern | Dallas | Texas | 75207 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Texas Liver Institute | San Antonio | Texas | 78215 | — |
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 17 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 Aug 30, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05035030 live on ClinicalTrials.gov.