Long-term outcomes of odevixibat (Bylvay) for people with PFIC in South Korea

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter observational registry collecting real-world information from people with any type of PFIC who have been prescribed odevixibat as part of routine care. Data will include safety events, symptom changes (including itching), liver-related outcomes, and long-term treatment patterns, with participants followed while on treatment and during permitted interruptions. Patients already enrolled in interventional odevixibat trials or other PFIC interventional trials are excluded. The registry is conducted at major tertiary centers in South Korea and will capture outcomes under usual clinical practice rather than a controlled protocol.

Why it matters

Who can join: the full rules

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.

Where it's running

• Pusan National University Yangsan Hospital
  Gyeongsang, South Korea Recruiting
• Severance Hospital, Yonsei University Health System
  Seoul, 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

Study contacts

• Study coordinator: Ipsen Clinical Study Enquiries
• Email: clinical.trials@ipsen.com
• Phone: See e mail

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Maralixibat (Livmarli) use in Alagille syndrome and PFIC — Japanese database analysis

  This project will look at Japanese patients with Alagille syndrome or PFIC who received maralixibat (Livmarli) to see if taking the drug is linked to liver problems.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.