Elafibranor Pregnancy Surveillance Program: A Study to Evaluate the Safety of Elafibranor During Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pregnancy Related. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- Prevalence of congenital malformations at birth [Time frame: At birth]
Secondary outcome measures (12)
- Prevalence of major congenital malformations at birth [Time frame: At birth]
- Prevalence of minor congenital malformations at birth [Time frame: At birth]
- Prevalence of molar/ectopic pregnancy [Time frame: Throughout pregnancy, an average of 9 months]
- Prevalence of fetal loss [Time frame: Throughout pregnancy, an average of 9 months]
- Prevalence of live birth [Time frame: At birth]
- Prevalence rate of premature delivery [Time frame: At birth]
- Prevalence of infants born small for gestational age (SGA) at birth [Time frame: At birth]
- Prevalence of neonatal death [Time frame: Within the first 28 days of life]
- Prevalence infant death [Time frame: Throughout the first year of life]
- Prevalence of postnatal growth deficiency [Time frame: Throughout the two years of life]
- Prevalence of infant developmental delay [Time frame: Throughout the two years of life]
- Prevalence of infant healthcare requirements and interventions not considered standard [Time frame: Throughout the two years of life]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Virtual Research Coordination Center — Wilmington
Identifiers
NCT: NCT07556913 · CLIN-60190-471