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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  YORVIPATH
• Study drug International non-proprietary name (INN) or common name:
  PALOPEGTERIPARATIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (H05AA05) palopegteriparatide

  palopegteriparatide
• Medical condition to be studied:
  Hypoparathyroidism

Population studied

• Short description of the study population:
  Pregnant women exposed to palopegteriparatide (YORVIPATH®) during pregnancy. Palopegteriparatide (YORVIPATH®) prescribed as per normal clinical practice.
• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 65 years)

    • Adults (18 to < 46 years)
    • Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  50

Study design details

• Outcomes:
  1. The number of fetuses as reported by HCP; 2. Pregnancy outcomes; • Live birth (preterm delivery, full-term delivery); • Spontaneous abortion; • Pregnancy termination; • Fetal death/stillbirth; • Molar or ectopic pregnancy; 3. Number of congenital malformations identified in the developing fetus, neonate, or infant; 4. Descriptive statistics of adverse events (AEs), including serious adverse events (SAEs); 5. Number of hospitalizations including reasons for hospitalization; 6. Descriptive statistics of growth and development milestones as described by the Centers for Disease Control and Prevention (CDC 2021) or other accepted standard assessment; 7. Number of signs of hypocalcemia or hypercalcemia; 8. Descriptive statistics of infant developmental deficiency (CDC 2021); 9. Descriptive statistics of postnatal growth deficiency or failure to thrive (FTT); 10. Descriptive statistics of neonatal and infant mortality; 11. Maternal complications of pregnancy; Including but not limited to; • Premature rupture of membranes (PROM); • Preterm PROM (PPROM); • Pre-eclampsia; • Gestational hypertension; • Eclampsia; • Proteinuria; • Gestational diabetes; • Intrauterine growth restriction (IUGR); • Polyhydramnios; • Preterm delivery; • Measures of fetal growth deficiency (e.g., small for gestational age); 12. Other maternal events of interest; Number of; • AEs, including SAEs; • Events specific to hypoparathyroidism (e.