Summary

Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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

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

Approximately 35 sites will be initiated for this study in North America, Europe, Middle East, and Asia Pacific.

Keywords

Alagille Syndrome Syndrome Odevixibat Odevixibat (A4250)

Eligibility

You can join if…

  1. Completion of the 24-week Treatment Period of Study A4250-012
  2. Signed informed consent and assent as appropriate. Patients who turn 18 years of age (or legal age per country) during the study will be required to re-consent to remain on the study
  3. Caregivers (and age-appropriate patients) must be willing and able to use an electronic diary (eDiary) device as required by the study
  4. Sexually active males and females must agree to use a reliable contraceptive method with ≤1% failure rate (such as hormonal contraception, intra-uterine device, or complete abstinence) from signed informed consent through 90 days after last dose of study drug.

You CAN'T join if...

  1. Decompensated liver disease, history or presence of clinically significant ascites, variceal hemorrhage, and/or encephalopathy
  2. Patients who were not compliant with study drug treatment or procedures in Study A4250-012
  3. Any other conditions or abnormalities which, in the opinion of the investigator, may compromise the safety of the patient, or interfere with the patient participating in or completing the study
  4. Known hypersensitivity to any components of odevixibat

Locations

  • UCSF
    San Francisco California 94158 United States
  • The Childrens Hospital at Montefiore Albert Einstein School of Medicine
    Bronx New York 10467 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Albireo
ID
NCT05035030
Phase
Phase 3
Study Type
Interventional
Last Updated