Actively Recruiting
Registry to Document Treatment Effectiveness, Safety, Including Prospective Long-term Outcomes in Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay)
Led by Ipsen · Updated on 2026-05-28
10
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are observing people with Progressive Familial Intrahepatic Cholestasis (PFIC), a rare liver disease causing poor liver function, itching, and yellowing of the skin. The study focuses on how people in South Korea use the medicine odevixibat (Bylvay) in their daily lives. Odevixibat has been approved in Europe, the United States, and South Korea for treating PFIC in babies and children with itching symptoms. This research aims to understand how well and how safely odevixibat works over a long period. Participants are those diagnosed with any type of PFIC who have been prescribed odevixibat by their doctor and are currently taking or starting this treatment. The study collects information while participants use odevixibat as part of their regular care, including times when treatment may be paused. There are no new treatments or procedures added by this registry study, and participants continue their usual medical care. During the study, researchers will collect data over approximately seven years, tracking any adverse events or side effects experienced by participants. They will also observe long-term outcomes such as survival without surgery, liver transplant, or other complications. This information will help understand how the treatment affects patients in real-world settings while monitoring safety and overall health during the follow-up period.
CONDITIONS
Brief 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 treating physician
- Currently taking or starting odevixibat treatment
- Participants may remain in the registry during temporary treatment interruptions
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 as per the approved label in South Korea
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 years
Participants taking odevixibat are observed for safety and long-term outcomes related to their condition.
Regular visits for data collection over approximately 7 years
Trial Site Locations
Total: 3 locations
1
Pusan National University Yangsan Hospital
Gyeongsang, South Korea
Actively Recruiting
2
Seoul National University Hospital
Seoul, South Korea
Active, Not Recruiting
3
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Actively Recruiting
Research Team
I
Ipsen Clinical Study Enquiries
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
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