Status:
COMPLETED
Efficacy and Safety of Odevixibat in Patients With Alagille Syndrome
Lead Sponsor:
Albireo
Conditions:
Alagille Syndrome
Eligibility:
All Genders
Phase:
PHASE3
Brief 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.
Detailed Description
Approximately 35 sites will be initiated for this study in North America, Europe, Middle East, and Asia Pacific.
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
March 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04674761
Start Date
March 19 2021
End Date
September 9 2022
Last Update
November 2 2023
Active Locations (32)
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1
University of California - San Francisco
San Francisco, California, United States, 94158
2
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
3
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
4
Children's Mercy Hospital and Clinics
Kansas City, Missouri, United States, 64108