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Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation

StatusRecruiting
PhaseNot specified
SponsorIpsen
Started
View on ClinicalTrials.gov ↗

Record History

  1. Secondary endpoints: details revised at 5 of 11 entries Eligibility criteria expanded, about 3 words Show 1 more changeShow less
    • Eligibility criteria expanded, about 3 words
  2. 8 versions Re-verified since Jan 30, 2026, no change to tracked fieldsv23-v30
  3. Primary completion date: Sep 2, 2031 to May 31, 2032 Completion date: Sep 2, 2032 to May 31, 2032v22 Show 1 more changeShow less
    • Completion date: Sep 2, 2032 to May 31, 2032
  4. 18 versions Re-verified since May 31, 2024, no change to tracked fieldsv4-v21
  5. Primary completion date: Sep 2, 2032 to Sep 2, 2031v3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Ipsen
46 trials monitored
See 4 trials at risk
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.
Trial Details
NCT Number NCT06258902
Lead Sponsor Ipsen
Conditions Pregnancy Related
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov