This study is in progress, not accepting new patients

Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome

a study on Alagille Syndrome

Summary

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

Description

Summary

Double-blind, randomized, placebo-controlled, Phase 3 study to investigate the efficacy and safety of odevixibat compared to placebo in Patients with Alagille Syndrome.

Official Title

A Phase 3 Double-blind, Randomized, Placebo-controlled Study of the Safety and Efficacy of Odevixibat (A4250) in Patients With Alagille Syndrome (ASSERT)

Details

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

Keywords

Alagille Syndrome, ALGS, Syndrome, Odevixibat, Odevixibat (A4250)

Eligibility

You can join if…

  • Genetically confirmed diagnosis of Alagille syndrome
  • History of significant pruritus as measured by the Albireo Observer or Patient Reported Outcome instrument
  • Elevated serum bile acid level

You CAN'T join if...

  • History or ongoing presence of other types of liver disease (eg. biliary atresia, progressive familial intrahepatic cholestasis, hepatocellular carcinoma)
  • History of liver transplant, or a liver transplant is planned within 6 months of randomization
  • ALT >10× upper limit of normal (ULN) at screening
  • Total bilirubin >15 × ULN at screening
  • Patient suffers from uncontrolled, recalcitrant pruritic condition other than Alagille syndrome

Locations

  • University of California - San Francisco
    San Francisco California 94158 United States
  • Oregon Health Science University School of Medicine
    Portland Oregon 97239 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Albireo
ID
NCT04674761
Phase
Phase 3 Alagille Syndrome Research Study
Study Type
Interventional
Participants
Expecting 63 study participants
Last Updated