Actively 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
Led by Ipsen · Updated on 2026-04-30
10
Participants Needed
3
Research Sites
361 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 PFIC, a type of rare disease that makes their liver not work well and causes itching and yellow skin. Odevixibat was first allowed to be used for PFIC in babies older than 6 months by the European Medicines Agency (EMA) on 16 July 2021 and by the United States Food and Drug Administration (FDA) on 20 July 2021 for itching in babies older than 3 months. Obevixibat was approved by the Ministry of Food and Drug Safety (MFDS) in South Korea on 23 August 2024. This study will collect information to see how well and how safe odevixibat is in the long run for participants in South Korea.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Progressive Familial Intrahepatic Cholestasis (PFIC) of any type and prescribed odevixibat by their doctor
- Currently taking or starting active treatment with odevixibat
- May remain in the registry even if odevixibat treatment is temporarily stopped
You will not qualify if you...
- Currently participating in a clinical trial involving odevixibat
- Currently participating in any other interventional clinical trial for PFIC
- Have any contraindications to odevixibat according to the approved label in South Korea
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Pusan National University Yangsan Hospital
Gyeongsang, South Korea
Active, Not Recruiting
2
Seoul National University Hospital
Seoul, South Korea
Not Yet Recruiting
3
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Actively Recruiting
Research Team
I
Ipsen Clinical Study Enquiries
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here