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Odevixibat Outcomes in Patients With PFIC Versus an External Control Cohort (OvEC-PFIC)

Study acronym: OvEC-PFIC
StatusActive, Not Recruiting
PhaseNot specified
SponsorIpsen
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later across 2 updates Aug 1, 2026 → Nov 30, 2026
See other at-risk trials from Ipsen

Record History

  1. Primary completion pushed from Sep 21, 2026 to Nov 30, 2026 Completion pushed from Sep 30, 2026 to Nov 30, 2026 · Eligibility criteria expanded, about 15 words · Secondary endpoints: details revised at 1 of 11 entries Show 3 more changesShow less
    • Completion pushed from Sep 30, 2026 to Nov 30, 2026
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 11 entries
  2. Primary completion pushed from Aug 1, 2026 to Sep 21, 2026v6
  3. 3 versions Re-verified since May 27, 2026, no change to tracked fieldsv3-v5
  4. Trial status changed: Not Yet Recruiting → Active, Not Recruiting Study sites: 0 to 1 · Start date changed from estimate of Apr 1, 2026 to Apr 26, 2026 · Study title shortened, about 4 wordsv2 Show 3 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 1, 2026 to Apr 26, 2026
    • Study title shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
Progressive familial intrahepatic cholestasis (PFIC) is a rare inherited liver disease that causes a build-up of bile acids in the liver. This can lead to severe itching (pruritus), poor sleep, impaired growth, liver damage, and in some cases the need for surgery or liver transplantation. The purpose of this non-interventional, retrospective study is to compare long-term health outcomes in patients with PFIC. The comparison is between patients who received odevixibat in two odevixibat clinical trials (Studies A4250-005 and A4250-008) and an aligned, balanced external control cohort of patients with PFIC from the Natural course and Prognosis of PFIC and Effect of biliary Diversion (NAPPED) registry who were not treated with odevixibat (or other ileal bile acid transporter \[IBAT\] inhibitors). Outcomes such as liver transplantation, death, and surgical biliary diversion (SBD) will be examined to better understand how treatment with odevixibat compares to the natural course of PFIC. This study aims to provide a robust comparative evaluation of long-term clinical outcomes with odevixibat.
Trial Details
NCT Number NCT07497724
Lead Sponsor Ipsen
Collaborators: Erasmus Medical Center, University Medical Center Groningen
Conditions PFIC - Progressive Familial Intrahepatic Cholestasis
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov