Recruiting

Odevixibat

Sponsor:

Ipsen

Code:

NCT06850038

Conditions

Alagille Syndrome

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Alagille Syndrome

Study ID

NCT06850038

Start date

Apr 22, 2025

Status verified date

Aug, 2026

Completion date

Nov 30, 2030

Anticipated

Primary completion date

Nov 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not 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

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Percentage of participants with Alagille syndrome (ALGS) who are treated with odevixibat and undergo biliary diversion surgery or liver transplantation. [ Time Frame: From first dose to end of study (approximately 5 years data collection) ]
  • Surgical biliary diversion-free survival [ Time Frame: From first dose to end of study (approximately 5 years data collection) ]
  • Liver transplant-free survival [ Time Frame: From first dose to end of study (approximately 5 years data collection) ]
  • Overall survival [ Time Frame: From first dose to end of study (approximately 5 years data collection) ]

Central Contacts and Locations

Central contacts

Ipsen Recruitment Enquiries

See emailclinical.trials@ipsen.com

Locations

Children's Hospital Los Angeles

Recruiting

Los Angeles, California, United States, 90027

UCSF Benioff Children's Hospital

Recruiting

San Francisco, California, United States, 94158

The Children's Mercy Hospital

Recruiting

Kansas City, Missouri, United States, 64108

SSM Health Cardinal Glennon Children's Hospital

Recruiting

St Louis, Missouri, United States, 63104

NYU Langone - NYU Grossman School of Medicine

Recruiting

New York, New York, United States, 10016

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

Recruiting

New York, New York, United States, 10032

Le Bonheur Children's Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Children's Medical Center Of Dallas

Recruiting

Dallas, Texas, United States, 75246

Proactive El Paso,LLC

Recruiting

El Paso, Texas, United States, 79902

More Information

Sponsor

Ipsen

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ipsen on 2026-08-31.