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

RecruitingObservational study

Prospective Registry-Based Study Evaluating the Effectiveness and Safety of Odevixibat in Participants With Alagille Syndrome (ALGS)

Who can join

All ages · All sexes

Full eligibility criteria
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

About the study

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.

Sponsor: Ipsen · Participants: 30 · Started: Apr 22, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06850038

Locations in the U.S.

CaliforniaChildren's Hospital Los Angeles, Los Angeles
UCSF Benioff Children's Hospital, San Francisco
MissouriThe Children's Mercy Hospital, Kansas City
SSM Health Cardinal Glennon Children's Hospital, St Louis
New YorkColumbia University Medical Center - Morgan Stanley Children's Hospital of NewYork - Presbyterian (MS-CHONY), New York
NYU Langone - NYU Grossman School of Medicine, New York
TennesseeLe Bonheur Children's Hospital, Memphis
TexasChildren's Medical Center Of Dallas, Dallas
Proactive El Paso,LLC, El Paso
UtahPrimary Children's Hospital (PCH) - Intermountain Healthcare/University of Utah, Salt Lake City (Not yet recruiting)

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.