Actively Recruiting
A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
Led by Ascendis Pharma A/S · Updated on 2026-03-02
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are collecting data in women who have been exposed to palopegteriparatide during pregnancy to understand the risks to the mother, fetus, and infant. This observational registry study aims to assess pregnancy outcomes, maternal complications, and any adverse effects on the developing fetus, newborn, and infant up to at least one year of age. The study focuses on women with hypoparathyroidism who have been treated with this medication around conception or during pregnancy. Participants include pregnant women who have taken at least one dose of YORVIPATH (palopegteriparatide) within 15 days before conception or during pregnancy. The medication is prescribed according to normal clinical practice. The study gathers data from these women without altering their treatment and includes only those who provide informed consent or assent with parental consent as applicable. During the study, researchers will collect information on the number of fetuses, pregnancy outcomes, congenital malformations, adverse events, hospitalizations, growth and development milestones, signs of calcium imbalance, infant developmental issues, mortality, and maternal complications. Data will be tracked up to 21 months after exposure to understand both short- and longer-term effects. Participants will provide medical information through healthcare providers, and ongoing monitoring will support safety assessments throughout this period.
CONDITIONS
Brief Title
A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 15 to 50 years
- Participants exposed to at least one dose of YORVIPATH within 15 days prior to conception or during pregnancy
- Participants able to provide written informed consent, verbal consent, or eConsent according to local regulations
- For adolescents under the age of majority, informed assent from the pregnant minor and consent from parent or legal guardian must be obtained
You will not qualify if you...
- Pregnancies where only the male partner was exposed to at least one dose of YORVIPATH
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for consent and eligibility assessment
Duration - Up to 21 months
Participants who are exposed to Palopegteriparatide during pregnancy are observed to assess maternal, fetal, and infant outcomes.
Periodic visits or contacts over the course of pregnancy and up to 21 months after birth
Trial Site Locations
Total: 1 location
1
Ascendis Investigational Site
Morgantown, West Virginia, United States, 26508
Actively Recruiting
Research Team
Y
Yorvipath Pregnancy Inquiries
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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