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

Ascendis Pharma

Status: Not yet enrolling

Conditions: Hypoparathyroidism

Treatments: Drug: Palopegteriparatide

Study type: Observational

Funder types: Industry

Identifiers

NCT07345494

ASND0043

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 15 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

50 participants in 1 patient group

Palopegteriparatide

Description:

Pregnant women exposed to palopegteriparatide during pregnancy

Treatment:

Drug: Palopegteriparatide