Summary

Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

Summary

The purpose of this study is to assess the long-term safety and effectiveness of odevixibat in participants with Alagille syndrome (ALGS).

The participants of this study will have ALGS a rare genetic disorder that can affect multiple organ systems of the body including the liver, heart, skeleton, eyes and kidneys. Common symptoms, which often develop during the first three months of life, include blockage of the flow of bile from the liver (cholestasis), yellowing of the skin and mucous membranes (jaundice), poor weight gain and growth and severe itching (pruritis).

The drug used for the study is odevixibat and was authorized for the treatment of cholestatic pruritus in infants with ALGS over 12 months of age by the United States Food and Drug Administration on 13 June 2023.

Official Title

An Open Label Study to Evaluate the Long-term Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT-EXT)

Details

Keywords

Alagille Syndrome, Syndrome, Odevixibat, Odevixibat (A4250)

Eligibility

Locations

  • UCSF in progress, not accepting new patients
    San Francisco California 94158 United States
  • UCSF (UCSF) accepting new patients
    San Francisco California 94158 United States
  • Texas Liver Institute accepting new patients
    San Antonio Texas 78215 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Albireo, an Ipsen Company
ID
NCT05035030
Phase
Phase 3 Alagille Syndrome Research Study
Study Type
Interventional
Participants
Expecting 70 study participants
Last Updated