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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

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NCT06850038 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

10 sites
Children's Hospital Los Angeles
Los Angeles, United States
UCSF Benioff Children's Hospital
San Francisco, United States
The Children's Mercy Hospital
Kansas City, United States
SSM Health Cardinal Glennon Children's Hospital
St Louis, United States
NYU Langone - NYU Grossman School of Medicine
New York, United States
Columbia University Medical Center - Morgan Stanley Children's Hospital of NewYork - Presbyterian (MS-CHONY)
New York, United States
Le Bonheur Children's Hospital
Memphis, United States
Children's Medical Center Of Dallas
Dallas, United States

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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