Condition: Progressive Familial Intrahepatic Cholestasis · Sponsor: Ipsen
This registry-based study will collect information from people with Progressive Familial Intrahepatic Cholestasis (PFIC) who take odevixibat (Bylvay) as part of routine clinical care in China. PFIC is a rare genetic liver disease that affects bile secretion and can cause bile acids to build up in the liver, which may lead to symptoms such as severe itching (pruritus). 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. Odevixibat is approved for the treatment of pruritus in PFIC and was approved in China on 01 December 2024 for patients 6 months of age and older with PFIC. The main aim of this registry is to assess long-term real-world safety (based on adverse events) and to describe effectiveness outcomes.
This description comes directly from the study's public registry record.
Ipsen Clinical Study Enquiries · See e-mail · Clinical.trials@ipsen.com
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| Capital Children's Medical Center | Beijing, China | Active Not Recruiting |
| Hunan Children's Hospital | Hunan, China | Recruiting |
| Children's Hospital of Fudan University Endocrinology and Metabolism | Shanghai, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07588880