Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in South Korea / NCT07185919
Recruiting Observational

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

NCT07185919 · tracked via the Priya Life Science South Korea tracker
Sponsor
Ipsen
Phase
Observational
Started
2025-10-30
Last updated
2026-10-01

Condition(s) studied

Progressive Familial Intrahepatic Cholestasis

Study 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 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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion criteria: 1. 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 2. On (or starting) active odevixibat treatment Note: Participants can remain in the registry during odevixibat treatment interruptions Exclusion criteria: 1. Currently participating in a clinical trial with odevixibat 2. Currently participating in any interventional clinical trial for PFIC 3. Have any contraindication to odevixibat as per the approved label in South Korea.

Primary outcome measure(s)

  • Percentage of participants experiencing Adverse Events (AEs) — From first ICF signature and up to end of data collection (approximately 7 years of data collection)
    An Adverse event (AE) is any untoward medical occurrence, temporally associated with the use of study intervention, whether or not related to the study intervention.

Trial sites (5)

FacilityCityRegionStatus
Pusan National University Yangsan Hospital Gyeongsang South Korea Recruiting
Asan Medical Center (AMC) Seoul South Korea Active Not Recruiting
Samsung Medical Center Seoul South Korea Active Not Recruiting
Seoul National University Hospital Seoul South Korea Active Not Recruiting
Severance Hospital, Yonsei University Health System Seoul South Korea Recruiting

More Ipsen trials in South Korea

A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity. Recruiting
A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults Active, not recruiting
A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment Active, not recruiting
A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis Recruiting
A Study to Assess How Well and Safely Elafibranor Works in Adult Participants With Primary Sclerosing Cholangitis Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07185919 on ClinicalTrials.gov ↗ ← All trials in South Korea