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NCT06258902 · ClinicalTrials.gov registry record
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
A clinical trial of Pregnancy Related, sponsored by Ipsen.
- Recruiting
- Registry status
- 20
- Enrollment target
- 1
- Study location
NCT06258902: Recruiting study of Pregnancy Related, sponsored by Ipsen.
NCT06258902 is a study of Pregnancy Related that is actively recruiting participants, run by Ipsen. The registered enrollment target is 20 participants, below the 1,963-participant average among 99 other Pregnancy Related trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06258902, a study of Pregnancy Related, is actively recruiting participants, sponsored by Ipsen.
- RECRUITING
- Registry status
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
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
An abnormality of body structure or function that is present at birth; is of prenatal origin (i.e. birth defect); has significant medical, social or cosmetic consequences for the affected individual; and typically requires medical intervention.
Conditions Studied
Study Locations (1)
North Carolina
- Virtual Research Coordination Center Odevixibat (BYLVAY) Pregnancy Surveillance Program - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-09-28 |
| Est. Completion | 2032-05-31 |
What NCT06258902 shows while recruiting
NCT06258902 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 1,963-participant average among 99 other Pregnancy Related trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Pregnancy Related appearing as the primary indexed condition, and to 0 interventions.
NCT06258902 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06258902 about?
NCT06258902 is a clinical study titled "Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation". 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...
What is the current status of trial NCT06258902?
This trial is currently recruiting. The enrollment target is 20 participants. The study started on 2023-09-28. Estimated completion is 2032-05-31.
What conditions does trial NCT06258902 study?
This clinical trial studies the following conditions: Pregnancy Related.
Who is sponsoring clinical trial NCT06258902?
This trial is sponsored by Ipsen, which has 85 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06258902 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy Related
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06258902's enrollment target sits among peer trials
20 94th of 99 higher than 5 of 99 other Pregnancy Related trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy Related trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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