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Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis

NCT04483531 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS

Last updated 2024-03-07

No results posted yet for this study

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

Conditions

  • Progressive Familial Intrahepatic Cholestasis

Interventions

DRUG

Odevixibat

A4250 is a small molecule and selective inhibitor of IBAT

Sponsors & Collaborators

  • Albireo

    lead INDUSTRY

Principal Investigators

  • Ipsen Medical Director · Ipsen

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04483531 on ClinicalTrials.gov