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

Официальное название

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

Обзор

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.

Первичные конечные точки

• Prevalence of congenital malformations at birth [Срок оценки: At birth]

Вторичные конечные точки (12)

• Prevalence of major congenital malformations at birth [Срок оценки: At birth]
• Prevalence of minor congenital malformations at birth [Срок оценки: At birth]
• Prevalence of molar/ectopic pregnancy [Срок оценки: Throughout pregnancy, an average of 9 months]
• Prevalence of fetal loss [Срок оценки: Throughout pregnancy, an average of 9 months]
• Prevalence of live birth [Срок оценки: At birth]
• Prevalence rate of premature delivery [Срок оценки: At birth]
• Prevalence of infants born small for gestational age (SGA) at birth [Срок оценки: At birth]
• Prevalence of neonatal death [Срок оценки: Within the first 28 days of life]
• Prevalence infant death [Срок оценки: Throughout the first year of life]
• Prevalence of postnatal growth deficiency [Срок оценки: Throughout the two years of life]
• Prevalence of infant developmental delay [Срок оценки: Throughout the two years of life]
• Prevalence of infant healthcare requirements and interventions not considered standard [Срок оценки: Throughout the two years of life]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

США · 1 центр

• Virtual Research Coordination Center — Wilmington

Идентификаторы

NCT: NCT07556913 · CLIN-60190-471

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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