drugset / Trial / NCT04483531

Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis

NCT04483531

Expanded access Approved for marketing Albireo

Summary

To provide treatment access to patients with PFIC in the US who have pruritus and elevated serum bile acids and who are not able to enroll in A4250-008 (PEDFIC2) for the following reasons: 1) Do not meet eligibility criteria for PEDFIC 2; 2) Are not able to get to a PEDFIC 2 site for geographical reasons, and 3) Do meet the eligibility criteria for PEDFIC 2 after recruitment has been completed

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Odevixibat Small molecule 120 ug/kg Oral