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Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy

StatusRecruiting
PhaseNot specified
SponsorIpsen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Interventions modified Trial arms changed: 0 → 1 · Secondary endpoints: details revised at 8 of 22 entries · Eligibility criteria expanded, about 4 words Show 3 more changesShow less
    • Trial arms changed: 0 → 1
    • Secondary endpoints: details revised at 8 of 22 entries
    • Eligibility criteria expanded, about 4 words
  2. Re-verified, no change to tracked fieldsv5
  3. Recruitment opened Study sites: 0 to 1 · Start date changed from estimate of Aug 15, 2026 to Jul 29, 2026v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Aug 15, 2026 to Jul 29, 2026
  4. Re-verified, no change to tracked fieldsv3
  5. Start date: Apr 30, 2026 to Aug 15, 2026v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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
The study will include participants who were exposed to at least one dose of elafibranor either within the three weeks before conception or at any time during pregnancy (based on estimated last menstrual period \[LMP\]). Information will be collected from participants, their healthcare providers, published studies, and safety databases. Reports of pregnancy linked to elafibranor from clinical trials, spontaneous reports, or literature will also be included, with steps taken to avoid duplicates. The study begins once the first participant is enrolled and ends after the last mother and child data are collected. It is planned to run for about 10 years, with infant follow-up lasting up to 2 years, for a maximum total duration of 12 years and 9 months. The program is strictly observational. All medical care, visit schedules, and treatment decisions remain with healthcare providers. Only routine medical record data will be collected, and no extra tests or procedures are required. Participation is voluntary, and written informed consent will be obtained before enrollment.
Trial Details
NCT Number NCT07556913
Lead Sponsor Ipsen
Conditions Pregnancy Related
Enrollment 3 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov