Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
NCT05035030 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Odevixibat
Study Locations (20)
New York
- Northwell Health System — New Hyde Park
- Hassenfeld Children's Hospital at NYU Langone — New York
- The Childrens Hospital at Montefiore Albert Einstein School of Medicine — The Bronx
Texas
- Childrens Medical Center of Dallas University of Texas Southwestern — Dallas
- Texas Children's Hospital — Houston
- Texas Liver Institute — San Antonio
California
- Rady Children's Hospital — San Diego
- UCSF — San Francisco
Other
- Cliniques Universitaires Saint-Luc Bruxelles — Brussels
- Hôpital Femme Mère Enfant de Lyon — Bron
Georgia
- Children's Healthcare of Atlanta — Atlanta
Indiana
- Riley Hospital for Children at IU Health — Indianapolis
Maryland
- Johns Hopkins Hospital — Baltimore
Massachusetts
- Boston Children's Hospital — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2021-09-03 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05035030
The ClinicalTrials.gov registry entry for NCT05035030 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albireo, an Ipsen Company, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Alagille Syndrome appearing as the primary indexed condition, and to 1 intervention — of which Odevixibat is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05035030 reports 20 study locations spanning 14 distinct geographic areas — top geographies include New York, Texas, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05035030 about?
NCT05035030 is a clinical study titled "Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome". 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, e...
What is the current status of trial NCT05035030?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2021-09-03. Estimated completion is 2026-12-31.
What conditions does trial NCT05035030 study?
This clinical trial studies the following conditions: Alagille Syndrome. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05035030?
The interventions under investigation include: Odevixibat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05035030?
This trial is sponsored by Albireo, an Ipsen Company, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05035030 being conducted?
This trial has 20 study locations across California, Georgia, Indiana, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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