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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

RECRUITINGSponsored by Ipsen
Actively Recruiting
SponsorIpsen
Started2025-04-22
Est. completion2029-11
Eligibility
Healthy vol.Accepted
Locations8 sites

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

Healthy volunteers accepted
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

Conditions3

Alagille SyndromeHeart DiseaseLiver Disease

Locations8 sites

Childrens Hospital Los Angeles
Los Angeles, California, 90027
UCSF Pediatric Gastroenterology
San Francisco, California, 94158
The Children's Mercy Hospital
Kansas City, Missouri, 64108
Columbia University
New York, New York, 10016
NYU Langone - NYU Grossman School of Medicine
New York, New York, 10016

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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