Recruiting NCT07345494
A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Palopegteriparatide.
- Who it may be relevant to
- Registry conditions: Hypoparathyroidism. Basic parameters: 15 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Interventions
- Drug Palopegteriparatide
Palopegteriparatide prescribed as per normal clinical practice
Primary outcome measures
- The number of fetuses as reported by HCP [Time frame: 21 months]
- Pregnancy outcomes [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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Ascendis Investigational Site — Morgantown
Identifiers
NCT: NCT07345494 · ASND0043