Recruiting

Palopegteriparatide

Sponsor:

Ascendis Pharma A/S

Code:

NCT07345494

Conditions

Hypoparathyroidism

Eligibility Criteria

Sex: Female

Age: 15 - 50

Healthy Volunteers: Not accepted

Interventions

Palopegteriparatide

Study Details

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

Study ID

NCT07345494

Start date

Feb 18, 2026

Status verified date

Feb, 2026

Completion date

Jan, 2036

Anticipated

Primary completion date

Jan, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 15 - 50

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Palopegteriparatide

Pregnant women exposed to palopegteriparatide during pregnancy

Interventions

Palopegteriparatide

Palopegteriparatide prescribed as per normal clinical practice

Primary outcome measure

  • 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 ]
  • Maternal complications of pregnancy [ Time Frame: 21 months ]
  • Other maternal events of interest [ Time Frame: 21 months ]

Central Contacts and Locations

Central contacts

Yorvipath Pregnancy Inquiries

877-229-2184yorvipathpregnancy@ubc.com

Locations

Ascendis Investigational Site

Recruiting

Morgantown, West Virginia, United States, 26508

More Information

Sponsor

Ascendis Pharma A/S

Last update posted

Mar 2, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ascendis Pharma A/S on 2026-03-02.