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Observing Odevixibat (Bylvay) for Alagille Syndrome

This study is observing how odevixibat (Bylvay) works in the long term for people with Alagille Syndrome (ALGS), a rare liver disease that causes itching. Researchers want to see how effective and safe odevixibat is in everyday life for patients already receiving this treatment. The study will look at whether participants need biliary diversion surgery (a procedure to reroute bile) or a liver transplant over about five years. Anyone diagnosed with ALGS and currently taking or starting odevixibat can join. The study aims to enroll 30 participants, but its current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will collect information as you use odevixibat in your daily life. It plans to include 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from their first dose of odevixibat until the end of the study, which is approximately 5 years of data collection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06850038

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

Recruiting
Not specifiedAll AgesObservational
Ipsen
~30 participants
Updated 2026-08-31 on ClinicalTrials.gov

At a glance

Recruiting sites
9 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of participants with Alagille syndrome (ALGS) who are treated with odevixibat and undergo biliary diversion surgery or liver transplantation.
Measured over From first dose to end of study (approximately 5 years data collection)
+3 more outcomes measured

Conditions

Alagille Syndrome

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Alagille Syndrome

NCT06850038

Where you'd take part

This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Hospital Los Angeles

    Los Angeles, Californiano site contact published

    Recruiting

  • Children's Medical Center Of Dallas

    Dallas, Texasno site contact published

    Recruiting

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

    New York, New Yorkno site contact published

    Recruiting

  • Le Bonheur Children's Hospital

    Memphis, Tennesseeno site contact published

    Recruiting

  • NYU Langone - NYU Grossman School of Medicine

    New York, New Yorkno site contact published

    Recruiting

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

    Salt Lake City, Utahno site contact published

    Not yet recruiting

  • Proactive El Paso,LLC

    El Paso, Texasno site contact published

    Recruiting

  • SSM Health Cardinal Glennon Children's Hospital

    St Louis, Missourino site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ipsen Medical, Director · STUDY_DIRECTOR · Ipsen

Who to contact

Ipsen Recruitment Enquiries
[email protected]
See email
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Percentage of participants with Alagille syndrome (ALGS) who are treated with odevixibat and undergo biliary diversion surgery or liver transplantation.From first dose to end of study (approximately 5 years data collection)
  • Surgical biliary diversion-free survivalFrom first dose to end of study (approximately 5 years data collection)

    Defined as time from the start of odevixibat treatment to the first occurrence of surgical biliary diversion or death.

  • Liver transplant-free survivalFrom first dose to end of study (approximately 5 years data collection)

    Defined as time from the start of odevixibat treatment to the first occurrence of liver transplant or death.

  • Overall survivalFrom first dose to end of study (approximately 5 years data collection)

    Defined as time from the start of odevixibat treatment to death.