Monitoring the safety of odevixibat during pregnancy and breastfeeding
Odevixibat Pregnancy and Lactation Surveillance Program: A Post-marketing, Long-term, Observational, Descriptive Study to Assess the Risk of Pregnancy and Maternal Complications and Adverse Effects on the Developing Fetus, Neonate, and Infant Among Individuals Exposed to Odevixibat During Pregnancy and/or Lactation
This study is looking to see if the medication odevixibat is safe for mothers and their babies during pregnancy and breastfeeding.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Sex | Female |
| Sponsor | Ipsen Industry-sponsored |
| Locations | 1 site (Wilmington, North Carolina) |
| Trial ID | NCT06258902 on ClinicalTrials.gov |
What this trial studies
This observational program aims to evaluate the safety of odevixibat in individuals who are pregnant or lactating. Participants of any age who have received at least one dose of odevixibat during pregnancy or lactation will be included. Data will be collected from various sources, including participants and healthcare providers, without requiring additional tests or assessments beyond routine medical care. The program focuses on gathering information on the effects of odevixibat on both mothers and infants.
Who should consider this trial
Good fit: Ideal candidates include pregnant or lactating individuals who have been exposed to odevixibat.
Not a fit: Patients who have not been exposed to odevixibat during pregnancy or lactation will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could provide valuable safety information regarding the use of odevixibat during pregnancy and lactation.
How similar studies have performed: While similar observational studies have been conducted, this specific program is novel in its focus on odevixibat during pregnancy and lactation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Exposure 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). * Informed consent or IRB-/EC-approved waiver of informed consent (not applicable if reported by Albireo PV according to usual pharmacovigilance practices) Exclusion Criteria: * Refusal to provide informed consent, if required
Where this trial is running
Wilmington, North Carolina
- Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program — Wilmington, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Ipsen Clinical Study Enquiries
- Email: clinical.trials@ipsen.com
- Phone: See e mail
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.