Condition: Pregnancy Related · Sponsor: Ipsen
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.
This description comes directly from the study's public registry record.
Ipsen Clinical Study Enquiries · See e mail · clinical.trials@ipsen.com
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| Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program | Wilmington, North Carolina, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06258902