NCT07588880 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
| NCT ID | NCT07588880 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ipsen |
| Condition | Progressive Familial Intrahepatic Cholestasis |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-04-16 |
| Primary Completion | 2031-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2026-04-16 with a primary completion date of 2031-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Ipsen Medical Director
STUDY DIRECTOR
Ipsen
Frequently Asked Questions
Who can join the NCT07588880 clinical trial?
This trial is open to participants of all sexes, aged 6 Months or older, studying Progressive Familial Intrahepatic Cholestasis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07588880 currently recruiting?
Yes, NCT07588880 is actively recruiting participants. Contact the research team at Clinical.trials@ipsen.com for enrollment information.
Where is the NCT07588880 trial being conducted?
This trial is being conducted at Beijing, China, Hunan, China, Shanghai, China.
Who is sponsoring the NCT07588880 clinical trial?
NCT07588880 is sponsored by Ipsen. The principal investigator is Ipsen Medical Director at Ipsen. The trial plans to enroll 20 participants.