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A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 15
Maximum Age: 50
Healthy Volunteers: f
View:

⁃ 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.

Locations
United States
West Virginia
Ascendis Investigational Site
RECRUITING
Morgantown
Contact Information
Primary
Yorvipath Pregnancy Inquiries
yorvipathpregnancy@ubc.com
877-229-2184
Time Frame
Start Date: 2026-02-18
Estimated Completion Date: 2036-01
Participants
Target number of participants: 50
Treatments
Palopegteriparatide
Pregnant women exposed to palopegteriparatide during pregnancy
Related Therapeutic Areas
Sponsors
Leads: Ascendis Pharma A/S

This content was sourced from clinicaltrials.gov

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