A Study Observing the Long-term, Effectiveness and Safety of Odevixibat (Bylvay) in Patients With Alagille Syndrome (ALGS) Who Are Receiving Ongoing Treatment

Recruiting now

Conditions studied: Alagille Syndrome

In brief

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 facts

Study ID

NCT06850038

Run by

Ipsen

People needed

30

Starts

2025-04-22

Expected to finish

2030-11-30

Last updated by the study team

2026-08-03

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with ALGS.
• On (or starting) active odevixibat treatment.
• Signed informed consent and assent, as appropriate. Consent/assent from the participant or legal representative should be obtained, as appropriate, before any study data collection is conducted. Participants who turn 18 years of age (or legal age per country) while participating in the study will be required to provide consent for themselves.

You may not qualify if…

• Currently participating in a clinical trial with odevixibat.
• Currently participating in any interventional clinical trial for ALGS.
• Have any contraindication to odevixibat as per the locally approved label.
• Had liver transplant before enrolment

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States (enrolling)
• UCSF Benioff Children's Hospital — San Francisco, California, United States (enrolling)
• The Children's Mercy Hospital — Kansas City, Missouri, United States (enrolling)
• SSM Health Cardinal Glennon Children's Hospital — St Louis, Missouri, United States (enrolling)
• NYU Langone - NYU Grossman School of Medicine — New York, New York, United States (enrolling)
• Columbia University Medical Center - Morgan Stanley Children's Hospital of NewYork - Presbyterian (MS-CHONY) — New York, New York, United States (enrolling)
• Le Bonheur Children's Hospital — Memphis, Tennessee, United States (enrolling)
• Children's Medical Center Of Dallas — Dallas, Texas, United States (enrolling)
• Proactive El Paso,LLC — El Paso, Texas, United States (enrolling)
• Primary Children's Hospital (PCH) - Intermountain Healthcare/University of Utah — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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