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NCT06850038Recruiting

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

Ipsen

Start Date

4/22/2025

Completion Date

11/1/2029

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.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria: * 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. Exclusion Criteria: * 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

Interested in This Trial?

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Conditions

Alagille Syndrome

Locations

Children's Hospital Los Angeles

Los Angeles, California 90027

United States

UCSF Benioff Children's Hospital

San Francisco, California 94158

United States

The Children's Mercy Hospital

Kansas City, Missouri 64108

United States

SSM Health Cardinal Glennon Children's Hospital

St Louis, Missouri 63104

United States

NYU Langone - NYU Grossman School of Medicine

New York, New York 10016

United States

Columbia University Medical Center - Morgan Stanley Children's Hospital of NewYork - Presbyterian (MS-CHONY)

New York, New York 10032

United States

Le Bonheur Children's Hospital

Memphis, Tennessee 38105

United States

Children's Medical Center Of Dallas

Dallas, Texas 75246

United States

Proactive El Paso,LLC

El Paso, Texas 79902

United States

Primary Children's Hospital (PCH) - Intermountain Healthcare/University of Utah

Salt Lake City, Utah 84113

United States