Status:
RECRUITING
A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in South Korea
Lead Sponsor:
Ipsen
Conditions:
Progressive Familial Intrahepatic Cholestasis
Eligibility:
All Genders
Brief Summary
This study will collect information from people with Progressive Familial Intrahepatic Cholestasis (PFIC) as they use odevixibat in their daily lives. Odevixibat is a medicine that helps people with P...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Diagnosed with PFIC (all types) who have been prescribed odevixibat (independently of the decision to enrol the participant in this registry) by their treating physician
- On (or starting) active odevixibat treatment Note: Participants can remain in the registry during odevixibat treatment interruptions
- Exclusion criteria:
- Currently participating in a clinical trial with odevixibat
- Currently participating in any interventional clinical trial for PFIC
- Have any contraindication to odevixibat as per the approved label in South Korea.
Exclusion
Key Trial Info
Start Date :
October 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2032
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07185919
Start Date
October 30 2025
End Date
September 30 2032
Last Update
December 11 2025
Active Locations (2)
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1
Seoul National University Hospital
Seoul, South Korea
2
Severance Hospital, Yonsei University Health System
Seoul, South Korea