Safety of elafibranor taken during pregnancy, with infant follow-up
Follows pregnant women who took elafibranor and their babies' health.
Plain-language title generated from the registry record
Registry title: Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
Key facts
- Where
- Wilmington, United StatesSee the site
Where in United States
- Virtual Research Coordination CenterWilmington, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ipsen
- Trial code
- NCT07556913
- Record updated
- 23 October 2026
- Original description
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]).Read full original descriptionShow less
Elafibranor Pregnancy Surveillance Program: A Post Marketing, Long Term, Multi-Center, Noninterventional, and Descriptive Study to Characterize Pregnancy and Maternal Complications and to Describe Effects on the Developing Fetus, Neonate and Infant Among Individuals Exposed to Elafibranor During Pregnancy
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.
Inclusion: Maternal exposure to at least one dose of elafibranor, either: Within three weeks prior to conception (based on the estimated date of LMP) or At any time during pregnancy (from the estimated date of conception through pregnancy outcome); Participants who were previously enrolled in this program during a past pregnancy and who meet inclusion criteria #1 for the subsequent pregnancy are eligible to enroll again; Informed consent or IRB/IEC-approved waiver of informed consent (not applicable if reported by Ipsen PV according to usual pharmacovigilance practices).
Exclusion: Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.