Status:
RECRUITING
A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
Lead Sponsor:
Ascendis Pharma A/S
Conditions:
Hypoparathyroidism
Eligibility:
FEMALE
15-50 years
Brief Summary
The purpose of this registry study is to collect both prospective and retrospective data in women exposed to palopegteriparatide during pregnancy to assess risk of pregnancy and maternal complications...
Eligibility Criteria
Inclusion Criteria:
- Participants aged 15 to 50 years
- Participants with exposure to at least one dose of YORVIPATH at any time within 15 days prior to conception and/or during pregnancy. The timeframe of 15 days prior to conception is calculated based on 5 times the YORVIPATH half life of ~ 60 hours
- Participants providing written informed consent, verbal consent, or eConsent (depending on country regulations) and a Medical Release of Information. For adolescents under the age of majority, verbal or written informed assent by the pregnant minor (where applicable) and verbal or written informed consent by the parent/legal guardian will be obtained.
Exclusion Criteria:
- Pregnancies in which only the male partner is exposed to at least one dose of YORVIPATH.
Key Trial Info
Start Date :
February 18 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2036
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07345494
Start Date
February 18 2026
End Date
January 1 2036
Last Update
March 2 2026
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Ascendis Investigational Site
Morgantown, West Virginia, United States, 26508