What this study is
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 applicable, and Albireo pharmacovigilance.
Study start date is either start of data collection or first patient enrolled whatever occurs earlier.
The surveillance program is strictly observational; the schedule of office visits and all treatment regimens are determined by HCPs. Only data that are routinely documented in patients' medical records as part of usual care will be collected.
No additional laboratory tests or HCP assessments will be required as part of this surveillance program.
Study details
- Official title
- 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
- Sponsor
- Ipsen
- Conditions
- Pregnancy Related
- Enrolling
- 20 people
- Starts
- 2023-09-28
- Est. completion
- 2032-05-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Sex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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)
You can't join if
- Refusal to provide informed consent, if required
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openVirtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program
Wilmington, North Carolina, United States
Recruiting
Study team
Sponsor
Ipsen
Study ID A4250-017
Study director
Ipsen Medical Director
Ipsen
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.