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

NCT07345494 | Recruiting FDA Drug

• 1 other identifier: ASND0043
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoparathyroidism

Outcome Measures

Primary Outcomes (12)

• The number of fetuses as reported by HCP

  21 months

• Pregnancy outcomes

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

  21 months

• Number of congenital malformations identified in the developing fetus, neonate, or infant

  21 months

• Descriptive statistics of adverse events (AEs), including serious adverse events (SAEs)

  21 months

• Number of hospitalizations including reasons for hospitalization

  21 months

• Descriptive statistics of growth and development milestones as described by the Centers for Disease Control and Prevention (CDC 2021) or other accepted standard assessment

  21 months

• Number of signs of hypocalcemia or hypercalcemia

  21 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 mortality

  21 months

• Maternal complications of pregnancy

  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)

  21 months

• Other maternal events of interest

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

  21 months

Study Arms (1)

Palopegteriparatide

Pregnant women exposed to palopegteriparatide during pregnancy

Drug: Palopegteriparatide

Interventions

Palopegteriparatide DRUG

Palopegteriparatide prescribed as per normal clinical practice

Palopegteriparatide

Eligibility Criteria

• Age: 15 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants with exposure to at least one dose of YORVIPATH at any time within 15 days prior to conception or during pregnancy. Prospective and retrospective pregnancies may be reported.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ascendis Pharma A/S: lead

Study Sites (1)

Ascendis Investigational Site

Morgantown, West Virginia, 26508, United States

RECRUITING

MeSH Terms

Conditions

Hypoparathyroidism

Condition Hierarchy (Ancestors)

Parathyroid Diseases; Endocrine System Diseases

Study Officials

• Medical Director, MD

  Ascendis Pharma A/S

  STUDY DIRECTOR

Central Study Contacts

Yorvipath Pregnancy Inquiries

CONTACT

877-229-2184; yorvipathpregnancy@ubc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 21 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: January 15, 2026
• Study Start: February 18, 2026
• Primary Completion (Estimated): January 1, 2036
• Study Completion (Estimated): January 1, 2036
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (1)