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NCT06850038 · ClinicalTrials.gov registry record
A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
A clinical trial of Alagille Syndrome, sponsored by Ipsen.
- Recruiting
- Registry status
- 30
- Enrollment target
- 8
- Study locations
NCT06850038 is a study of Alagille Syndrome that is actively recruiting participants, run by Ipsen. The registered enrollment target is 30 participants, below the 58-participant average among 3 other Alagille Syndrome trials with a reported enrollment target (48% lower). The trial reports 8 study locations across 5 states.
The verdict
NCT06850038, a study of Alagille Syndrome, is actively recruiting participants, sponsored by Ipsen.
- RECRUITING
- Registry status
- 30 participants
- Enrollment target
- 8
- Study locations
Study Summary
This study will collect information from patients with Alagille syndrome (ALGS) as they use odevixibat (Bylvay) in their daily lives. Odevixibat is a medicine that helps patients with ALGS, a rare disease that harms their liver and causes itching. The main aim of this study is to observe the long-term, everyday effectiveness and safety of the drug odevixibat in patients with ALGS who are receiving ongoing treatment.
Conditions Studied
Study Locations (8)
California
- Childrens Hospital Los Angeles - Los Angeles
- UCSF Pediatric Gastroenterology - San Francisco
New York
- Columbia University - New York
- NYU Langone - NYU Grossman School of Medicine - New York
Texas
- UT Southwestern Childrens Medical Center - Dallas
- Proactive El Paso,LLC - El Paso
Missouri
- The Children's Mercy Hospital - Kansas City
Tennessee
- Le Bonheur Children's Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-04-22 |
| Est. Completion | 2029-11 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06850038
The ClinicalTrials.gov registry entry for NCT06850038 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 58-participant average among 3 other Alagille Syndrome trials with a reported enrollment target (48% lower). The listed sponsor is Ipsen, which has 85 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alagille Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT06850038 reports 8 study locations spanning 5 distinct geographic areas - top geographies include California, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT06850038 about?
NCT06850038 is a clinical study titled "A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment". This study will collect information from patients with Alagille syndrome (ALGS) as they use odevixibat (Bylvay) in their daily lives. Odevixibat is a medicine that helps patients with ALGS, a rare disease that harms their liver and causes itching. The main aim of this study is to observe the long-...
What is the current status of trial NCT06850038?
This trial is currently recruiting. The enrollment target is 30 participants. The study started on 2025-04-22. Estimated completion is 2029-11.
What conditions does trial NCT06850038 study?
This clinical trial studies the following conditions: Alagille Syndrome.
Who is sponsoring clinical trial NCT06850038?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06850038 being conducted?
This trial has 8 study locations across California, Missouri, New York, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Long-term Safety and Efficacy of Odevixibat in Patients With Alagille Syndrome
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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
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Read our methodology - how this data is sourced, computed, and verified.
Related
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