RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-14
Study Completion:2029-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06850038

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosed with ALGS.
  2. * On (or starting) active odevixibat treatment.
  3. * 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.
  1. * Currently participating in a clinical trial with odevixibat.
  2. * Currently participating in any interventional clinical trial for ALGS.
  3. * Have any contraindication to odevixibat as per the locally approved label.
  4. * Had liver transplant before enrolment

Contacts and Locations

Study Contact

Ipsen Recruitment Enquiries
CONTACT
See email
clinical.trials@ipsen.com

Principal Investigator

Ipsen Medical, Director
STUDY_DIRECTOR
Ipsen

Study Locations (Sites)

NYU Langone - NYU Grossman School of Medicine
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: Ipsen

  • Ipsen Medical, Director, STUDY_DIRECTOR, Ipsen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-14
Study Completion Date2029-11

Study Record Updates

Study Start Date2025-04-14
Study Completion Date2029-11

Terms related to this study

Additional Relevant MeSH Terms

  • Alagille Syndrome