Trial Now Recruiting: Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation (NCT06258902)
WHY IT MATTERS
This surveillance program is recruiting pregnant and lactating women exposed to odevixibat to establish safety data for a medication used in rare bile acid disorders, filling a critical gap in pregnancy and lactation safety information.
Researchers are looking for pregnant women and breastfeeding mothers who have taken or are taking a medication called odevixibat to join a safety study. The study will track the health of these women and their babies to make sure the medication is safe to use during pregnancy and while breastfeeding. About 20 people will participate, and doctors will collect information from the mothers, babies, and healthcare providers involved in their care.
NCT ID: NCT06258902 Status: RECRUITING Conditions: Pregnancy Related Enrollment: 20 Sponsor: Ipsen Summary: The participants of this study will be of any age who are exposed to at least 1 dose of odevixibat at any time during pregnancy (from 1 day prior to conception to pregnancy outcome) and/or at any time during lactation (up to 12 months of infant age or weaning, whichever comes first. This study will collect data obtained via a variety of sources, including enrolled pregnant or lactating participants, the healthcare providers (HCP) involved in their care or the care of their infants, if applicabl
YOU CAN ACT ON THIS
If you are pregnant, planning pregnancy, or breastfeeding while taking odevixibat, contact the study team at the NCT06258902 trial or speak with your doctor about enrollment eligibility.