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

NCT07556913 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2026-06-01

No results posted yet for this study

Summary

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.

Conditions

  • Pregnancy Related

Sponsors & Collaborators

Principal Investigators

  • Ipsen Medical Director · Ipsen

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2039-01-31
Completion
2039-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07556913 on ClinicalTrials.gov