A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment
Part of paid clinical trials in Los Angeles, California.
- Sponsor
- Ipsen
- Study ID
- NCT06850038
- Status
- Recruiting
Conditions
- Alagille Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- Apr 22, 2025
- Status verified
- May 2026
- Primary completion
- Nov 30, 2029
- Completion
- Nov 30, 2029
Study Design
- Enrollment
- 30 participants (estimated)
Primary Outcome Measure
Percentage of participants with Alagille syndrome (ALGS) who are treated with odevixibat and undergo biliary diversion surgery or liver transplantation. [ Time Frame: From first dose to end of study (approximately 5 years data collection) ]
Central Contacts
- Ipsen Recruitment EnquiriesSee email
Locations (10)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | - |
| UCSF Benioff Children's Hospital | San Francisco | California | 94158 | - |
| The Children's Mercy Hospital | Kansas City | Missouri | 64108 | - |
| SSM Health Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | - |
| Columbia University Medical Center - Morgan Stanley Children's Hospital of NewYork - Presbyterian (MS-CHONY) | New York | New York | 10032 | - |
| NYU Langone - NYU Grossman School of Medicine | New York | New York | 10016 | - |
| Le Bonheur Children's Hospital | Memphis | Tennessee | 38105 | - |
| Children's Medical Center Of Dallas | Dallas | Texas | 75246 | - |
| Proactive El Paso,LLC | El Paso | Texas | 79902 | - |
| Primary Children's Hospital (PCH) - Intermountain Healthcare/University of Utah | Salt Lake City | Utah | 84113 | - |
Find similar trials in Los Angeles, CA
By research site
Children's Hospital Los Angeles· Los Angeles, CAUCSF Benioff Children's Hospital· San Francisco, CAThe Children's Mercy Hospital· Kansas City, MOSSM Health Cardinal Glennon Children's Hospital· St Louis, MOColumbia University Medical Center - Morgan Stanley Children's Hospital of NewYork - Presbyterian (MS-CHONY)· New York, NYNYU Langone - NYU Grossman School of Medicine· New York, NY
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