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A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in China

Recruitingn/aAges 6 Months - anyAllIpsen
NCT07588880 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 eff

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📋 Eligibility rules (as published)
Inclusion Criteria: * Diagnosed with PFIC (all types) who have been prescribed odevixibat (independently of the decision to enroll the participant in this registry) by their treating physician * On (or starting) active odevixibat treatment (participants can remain in the registry during odevixibat treatment interruptions) * Signed informed consent and assent, as appropriate 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 China
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What it tests

  • Not listed
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Where

6 sites
Capital Children's Medical Center
Beijing, China
Chongqing Medical University - Children's Hospital
Chongqing, China
Hunan Children's Hospital
Hunan, China
Nanjing Medical University-Nanjing Children's Hospital
Nanjing, China
Children's Hospital of Fudan University Endocrinology and Metabolism
Shanghai, China
Xiamen Children's Hospital
Xiamen, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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