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NCT Number: NCT07556913

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

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Key information

Conditions

Pregnancy Related Bile Duct Diseases Biliary Tract Diseases Cholestasis Cholestasis, Intrahepatic Digestive System Diseases Disease Attributes Fibrosis Liver Cirrhosis Liver Cirrhosis, Biliary Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases

Sex eligibility

Female

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Prevalence of congenital malformations at birth

    Time frame: At birth

Secondary outcomes

  1. Prevalence of major congenital malformations at birth

    Time frame: At birth

    An abnormality of body structure or function that is present at birth; is of prenatal origin (i.e. birth defect); has significant medical, social, or cosmetic consequences for the affected individual; and typically requires medical intervention

  2. Prevalence of minor congenital malformations at birth

    Time frame: At birth

    An anomaly or abnormality of body structure that is present at birth, is of prenatal origin (i.e. birth defect), poses no significant health problem in the neonatal period, and tends to have limited social or cosmetic consequences for the affected individual

  3. Prevalence of molar/ectopic pregnancy

    Time frame: Throughout pregnancy, an average of 9 months

    Molar pregnancy is defined as an abnormal pregnancy that happens when a sperm fertilizes an egg that does not contain any genetic material. Ectopic pregnancy is defined as a pregnancy that occurs outside of the uterine cavity, usually in one of the fallopian tubes.

  4. Prevalence of fetal loss

    Time frame: Throughout pregnancy, an average of 9 months

    A fetal loss that occurs for any reason at any time during pregnancy. This includes spontaneous abortion (SAB), stillbirth, elective or therapeutic abortion, fetal loss (type not specified).

  5. Prevalence of live birth

    Time frame: At birth

    The birth of a living fetus at ≥ 20 gestational weeks or, if gestational age is unknown, weighing ≥ 350g.

  6. Prevalence rate of premature delivery

    Time frame: At birth

    A live birth occurring at <37 gestational weeks.

  7. Prevalence of infants born small for gestational age (SGA) at birth

    Time frame: At birth

    Birth weight <10th percentile for sex and gestational age using standard growth charts for full and preterm live-born infants.

  8. Prevalence of neonatal death

    Time frame: Within the first 28 days of life

  9. Prevalence infant death

    Time frame: Throughout the first year of life

  10. Prevalence of postnatal growth deficiency

    Time frame: Throughout the two years of life

    Weight, length, or head circumference in <10th percentile for sex and age using standard growth charts

  11. Prevalence of infant developmental delay

    Time frame: Throughout the two years of life

    Failure to achieve the developmental milestones for chronological age, as defined by the Centers for Disease Control and Prevention (CDC)

  12. Prevalence of infant healthcare requirements and interventions not considered standard

    Time frame: Throughout the two years of life

    including but not limited to:

    • Infant hospitalization due to serious illness
    • Emergency department visits
    • Specialist or other healthcare professional consultations
    • Developmental assessments and interventions
    • Therapeutic services
    • Educational support and adaptations

  13. Incidence and nature of all adverse events in pregnant participants

    Time frame: Throughout pregnancy, an average of 9 months

  14. Changes from baseline in Alkaline phosphatase (ALP)

    Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months

  15. Changes from baseline in Bilirubin

    Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months

  16. Changes from baseline in Alanine aminotransferase (ALT)

    Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months

  17. Changes from baseline in Aspartate aminotransferase (AST)

    Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months

  18. Changes from baseline in Gamma-glutamyl transferase (GGT)

    Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months

  19. Changes from baseline in Albumin

    Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months

  20. Changes from baselinein Bile Acids

    Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months

  21. Changes from baseline in Creatine phosphokinase (CPK)

    Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months

  22. Changes from baseline in Lipid Profile

    Time frame: From the time of first elafibranor exposure throughout pregnancy and postpartum, an average of 2 years and 9 months

    Lipid profile includes total cholesterol, low density lipoproteins (LDL-C), high density lipoprotein (HDL-C), very low density lipoprotein and triglycerides

Study contacts

Contact information is provided by the study sponsor or research team.

Ipsen Clinical Study Enquiries

CONTACT

[email protected]

See e-mail

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2039
Study completion
2039
First posted
Apr 29, 2026
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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