NCT07345494Recruiting
A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
Ascendis Pharma A/S
Start Date
2/18/2026
Completion Date
1/1/2036
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, and adverse effects on the developing fetus, neonate, and infant and to assess infant outcomes through at least the first year of life.
Eligibility Criteria
Age Range: 15 years to 50 years
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.
Interventions
DRUG
Palopegteriparatide
Conditions
Hypoparathyroidism
Locations
Ascendis Investigational Site
Morgantown, West Virginia 26508
United States