Elafibranor Pregnancy Safety Registry
Official title: 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
Run by Ipsen · NCT07556913 · Data updated 2026-11-12
This is an observational program to see if elafibranor exposure before or during pregnancy is safe for mothers and babies.
Quick facts
| Study type | Observational |
|---|---|
| Sex | Women only |
| Enrollment | 3 (estimated) |
| Sponsor | Ipsen Industry-sponsored |
| Locations | 1 site (Wilmington, North Carolina) |
| Status | Recruiting |
| Started | July 29, 2026 |
| Main results expected | January 31, 2039 |
| Study ends | January 31, 2039 |
| Registry record updated | October 23, 2026 |
| Trial ID | NCT07556913 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant individuals or those planning pregnancy who were exposed to at least one dose of elafibranor before conception or during pregnancy.
✕Probably not a fit
Pregnant individuals without elafibranor exposure and those for whom no pregnancy outcomes are collected may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This program collects routine medical information from mothers, their healthcare providers, published studies, and safety databases to track outcomes after exposure to elafibranor around conception or during pregnancy. It is strictly observational, with care decisions left to clinicians and no extra tests required. Enrollment starts with the first participant and the study aims to follow mother–child pairs for up to 12 years 9 months in total, including up to 2 years of infant follow-up.
Why it matters
Potential benefit: Findings could clarify pregnancy safety for elafibranor and help guide clinical decisions for mothers with relevant conditions.
How similar studies have gone: There have been prior safety-focused reports and spontaneous data on elafibranor, but systematic long-term observational data in pregnancy are less common.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
Where it's running
-
Virtual Research Coordination Center
Wilmington, North Carolina, United States Recruiting
Study contacts
- Study coordinator: Ipsen Clinical Study Enquiries
- Email: clinical.trials@ipsen.com
- Phone: See e-mail
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.