Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Albireo

Criteria

Key Inclusion Criteria:

• 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

Key Exclusion Criteria:

• 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