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

a study on Alagille Syndrome

Summary

Location
at UCSF
Dates
study started
study ends around

Description

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.

Official Title

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

Keywords

Alagille Syndrome

Eligibility

You can join if…

  • 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.

You CAN'T join if...

  • 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

Locations

  • UCSF Pediatric Gastroenterology accepting new patients
    San Francisco California 94158 United States
  • Childrens Hospital Los Angeles accepting new patients
    Los Angeles California 90027 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ipsen
ID
NCT06850038
Study Type
Observational [Patient Registry]
Participants
Expecting 30 study participants
Last Updated
Contact us about this trial