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YORVIPATH® Pregnancy Registry for Hypoparathyroidism

This study is a registry to understand the effects of YORVIPATH® (Palopegteriparatide) when used by women with hypoparathyroidism (a condition where the body doesn't make enough parathyroid hormone) during pregnancy and breastfeeding. Researchers want to collect information on how YORVIPATH® affects the mother, the developing baby, and the infant after birth. They will look at pregnancy outcomes and any birth defects. You may be able to join if you are a woman between 15 and 50 years old and have been exposed to YORVIPATH® shortly before or during pregnancy. The study aims to enroll 50 participants. The success of this study will be measured by tracking the number of babies, pregnancy outcomes, and any birth defects identified up to 21 months.

Study design
This is an observational study, meaning researchers will collect information without giving you a specific treatment. It plans to include 50 women.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to assess pregnancy outcomes and congenital malformations up to 21 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07345494

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

Recruiting
Not specifiedAges 15–50Observational
Ascendis Pharma A/S
~50 participants
Updated 2026-03-02 on ClinicalTrials.gov
What's tested:Palopegteriparatide

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The number of fetuses as reported by HCP
Measured over 21 months
+11 more outcomes measured

Conditions

Hypoparathyroidism

Explore related trials

Hypoparathyroidism

Where it's being run

1 sites across 1 states
West Virginia1

Study leadership

  • Medical Director, MD · STUDY_DIRECTOR · Ascendis Pharma A/S

Who to contact

Yorvipath Pregnancy Inquiries
[email protected]
877-229-2184
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Pregnancies in which only the male partner is exposed to at least one dose of YORVIPATH.

What this trial measures

  • The number of fetuses as reported by HCP21 months
  • Pregnancy outcomes21 months

    * Live birth (preterm delivery, full-term delivery) * Spontaneous abortion * Pregnancy termination * Fetal death/stillbirth * Molar or ectopic pregnancy

  • Number of congenital malformations identified in the developing fetus, neonate, or infant21 months
  • Descriptive statistics of adverse events (AEs), including serious adverse events (SAEs)21 months
  • Number of hospitalizations including reasons for hospitalization21 months
  • Descriptive statistics of growth and development milestones as described by the Centers for Disease Control and Prevention (CDC 2021) or other accepted standard assessment21 months
  • Number of signs of hypocalcemia or hypercalcemia21 months
  • Descriptive statistics of infant developmental deficiency (CDC 2021)21 months
  • Descriptive statistics of postnatal growth deficiency or failure to thrive (FTT)21 months
  • Descriptive statistics of neonatal and infant mortality21 months
  • Maternal complications of pregnancy21 months

    Including but not limited to * Premature rupture of membranes (PROM) * Preterm PROM (PPROM) * Pre-eclampsia * Gestational hypertension * Eclampsia * Proteinuria * Gestational diabetes * Intrauterine growth restriction (IUGR) * Polyhydramnios * Preterm delivery * Measures of fetal growth deficiency (e.g., small for gestational age)

  • Other maternal events of interest21 months

    Number of * AEs, including SAEs * Events specific to hypoparathyroidism (e.g., hypercalcemia, hypocalcemia). Serum calcium concentrations at each trimester (if available) and at birth