Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pregnancy Related. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Primary outcome measures
- Prevalence rate of major congenital malformations (MCM) at birth [Time frame: At birth]
Secondary outcome measures (11)
- Prevalence rate of minor congenital malformations at birth [Time frame: At birth]
- Prevalence rate of molar or ectopic pregnancy [Time frame: Throughout pregnancy, an average of 9 months]
- Prevalence rate of fetal loss [Time frame: Throughout pregnancy, an average of 9 months]
- Prevalence rate of live birth [Time frame: At birth]
- Prevalence rate of preterm birth [Time frame: At birth]
- Prevalence rate of small for gestational age (SGA) [Time frame: At birth]
- Prevalence rate of neonatal death [Time frame: Within the first 28 days of life]
- Prevalence rate of infant death [Time frame: Throughout the first year of life]
- Prevalence rate of postnatal growth deficiency [Time frame: Throughout the first year of life]
- Prevalence rate of infant developmental delay [Time frame: Throughout the first year of life]
- Prevalence rate of infant hospitalization due to serious illness [Time frame: Throughout the first year of life]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program — Wilmington
Identifiers
NCT: NCT06258902 · A4250-017