Pregnancy registry tracking outcomes after YORVIPATH exposure during pregnancy and breastfeeding
A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
This registry collects information from pregnant or breastfeeding people with hypoparathyroidism who took YORVIPATH to see if the exposure affects pregnancy, the baby, or infant outcomes through the first year of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 15 Years to 50 Years |
| Sex | Female |
| Sponsor | Ascendis Pharma A/S Industry-sponsored |
| Locations | 1 site (Morgantown, West Virginia) |
| Trial ID | NCT07345494 on ClinicalTrials.gov |
What this trial studies
This is an observational registry collecting both prospective and retrospective data on people with hypoparathyroidism who were exposed to YORVIPATH during pregnancy or within the 15 days before conception. Data will include pregnancy and maternal complications, fetal and neonatal outcomes, and infant follow-up through at least the first year of life, using medical records and participant-provided information. Participants must provide consent (or assent with guardian consent for minors) and a medical release of information to allow data collection. The registry is sponsored by Ascendis Pharma and lists enrollment through the Ascendis Investigational Site in Morgantown, West Virginia.
Who should consider this trial
Good fit: Ideal candidates are people aged 15–50 with hypoparathyroidism who received at least one dose of YORVIPATH within 15 days before conception or at any time during pregnancy and who can provide consent and a medical release.
Not a fit: People who were not exposed to YORVIPATH during the specified window or pregnancies where only the male partner was exposed are not eligible and would not benefit from this registry's findings.
Why it matters
Potential benefit: If successful, the registry could provide clearer safety information to help pregnant people and clinicians make informed treatment and counseling decisions about YORVIPATH use.
How similar studies have performed: Pregnancy registries for other medications have helped identify safety signals and guide counseling, but pregnancy-specific data for YORVIPATH are novel and limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Morgantown, West Virginia
- Ascendis Investigational Site — Morgantown, West Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Yorvipath Pregnancy Inquiries
- Email: yorvipathpregnancy@ubc.com
- Phone: 877-229-2184
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.