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

N/ANot Yet RecruitingNCT07345494

Ascendis Pharma A/S50 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hypoparathyroidism

Interventions

PalopegteriparatideDRUG

Palopegteriparatide prescribed as per normal clinical practice

Eligibility

Sex: FEMALEMin age: 15 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The number of fetuses as reported by HCP

Time frame: 21 months

Pregnancy outcomes

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

Time frame: 21 months

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

Time frame: 21 months

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

Time frame: 21 months

Number of hospitalizations including reasons for hospitalization

Time frame: 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

Time frame: 21 months

Number of signs of hypocalcemia or hypercalcemia

Time frame: 21 months

Descriptive statistics of infant developmental deficiency (CDC 2021)

Time frame: 21 months

Descriptive statistics of postnatal growth deficiency or failure to thrive (FTT)

Time frame: 21 months

Descriptive statistics of neonatal and infant mortality

Time frame: 21 months

Maternal complications of pregnancy

Central Contacts

Yorvipath Pregnancy Inquiries

CONTACT

877-229-2184 yorvipathpregnancy@ubc.com

Data from ClinicalTrials.gov

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