Recruiting

Elafibranor

Sponsor:

Ipsen

Code:

NCT07556913

Conditions

Pregnancy Related

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief 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

Study ID

NCT07556913

Start date

Jul 29, 2026

Status verified date

Aug, 2026

Completion date

Jan 31, 2039

Anticipated

Primary completion date

Jan 31, 2039

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

3 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Prevalence of congenital malformations at birth [ Time Frame: At birth ]

Central Contacts and Locations

Central contacts

Ipsen Clinical Study Enquiries

See e-mailclinical.trials@ipsen.com

Locations

Virtual Research Coordination Center

Recruiting

Wilmington, North Carolina, United States, 28401

More Information

Sponsor

Ipsen

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Rare disease
  • Primary Biliary Cholangitis
  • Pregnancy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ipsen on 2026-08-31.