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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age15-50
SponsorAscendis Pharma A/S

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Palopegteriparatide

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators