Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 45-participant average among 3 other Alagille Syndrome trials with a reported enrollment target (56% higher). The listed sponsor is Albireo, an Ipsen Company, which has 3 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.
Learn More About Clinical Trials
Similar trials for Alagille Syndrome
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
RECRUITING
-
Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)
RECRUITING
-
An Extension Study to Evaluate the Long-Term Safety and Durability of Effect of LUM001 in the Treatment of Cholestatic Liver Disease in Pediatric Subjects With Alagille Syndrome
COMPLETED · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.