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NCT05035030 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
A Phase 3 study of Alagille Syndrome, sponsored by Albireo, an Ipsen Company.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 70
- Enrollment target
- 20
- Study locations
NCT05035030: Recruiting Phase 3 study of Alagille Syndrome, sponsored by Albireo, an Ipsen Company.
NCT05035030 is a Phase 3 study of Alagille Syndrome that is actively recruiting participants, run by Albireo, an Ipsen Company. The registered enrollment target is 70 participants, above the 45-participant average among 3 other Alagille Syndrome trials with a reported enrollment target (56% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05035030, a Phase 3 study of Alagille Syndrome, is actively recruiting participants, sponsored by Albireo, an Ipsen Company.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 70 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Assessed as change in scratching score as measured by measured by the Albireo Observer-Reported Outcome Caregiver Instrument.
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 |
What NCT05035030 shows while recruiting
NCT05035030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 45-participant average among 3 other Alagille Syndrome trials with a reported enrollment target (56% higher).
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.
NCT05035030 names 20 study sites across 14 states, led by New York, Texas, California.
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.
What interventions are being tested in trial NCT05035030?
The interventions under investigation include: Odevixibat (DRUG).
Who is sponsoring clinical trial NCT05035030?
This trial is sponsored by Albireo, an Ipsen Company, which has 3 total clinical trials registered on ClinicalTrials.gov.
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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