NCT07345494 A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
| NCT ID | NCT07345494 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ascendis Pharma A/S |
| Condition | Hypoparathyroidism |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-02-18 |
| Primary Completion | 2036-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2026-02-18 with a primary completion date of 2036-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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, 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
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.
Contact & Investigator
Medical Director, MD
STUDY DIRECTOR
Ascendis Pharma A/S
Frequently Asked Questions
Who can join the NCT07345494 clinical trial?
This trial is open to female participants only, aged 15 Years or older, up to 50 Years, studying Hypoparathyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07345494 currently recruiting?
Yes, NCT07345494 is actively recruiting participants. Contact the research team at yorvipathpregnancy@ubc.com for enrollment information.
Where is the NCT07345494 trial being conducted?
This trial is being conducted at Morgantown, United States.
Who is sponsoring the NCT07345494 clinical trial?
NCT07345494 is sponsored by Ascendis Pharma A/S. The principal investigator is Medical Director, MD at Ascendis Pharma A/S. The trial plans to enroll 50 participants.