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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 South Korea

StatusRecruiting
PhaseNot specified
SponsorIpsen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 4 to 5 Eligibility criteria expanded, about 5 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 5 words
  2. Study sites: 3 to 4v11
  3. 2 versions Re-verified since Jul 1, 2026, no change to tracked fieldsv9-v10
  4. Site details revised at 2 of 3 sitesv8
  5. Study sites: 2 to 3v7
Show 5 earlier versionsHide 5 earlier versions
  1. 4 versions Re-verified since Dec 4, 2025, no change to tracked fieldsv3-v6
  2. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Sep 2031 to Sep 30, 2032 · Study sites: 0 to 2 · Start date changed from estimate of Sep 2025 to Oct 30, 2025v2 Show 3 more changesShow less
    • Primary and study completion dates: Sep 2031 to Sep 30, 2032
    • Study sites: 0 to 2
    • Start date changed from estimate of Sep 2025 to Oct 30, 2025
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ipsen
46 trials monitored
See 4 trials at risk
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.
Trial Details
NCT Number NCT07185919
Lead Sponsor Ipsen
Conditions Progressive Familial Intrahepatic Cholestasis
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov