clinical trial · NCT06299748
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
argenx·—·recruiting·n = 279
Myasthenia GravisCIDP - Chronic Inflammatory Demyelinating PolyneuropathyEfgartigimod
brief summary
This is a multi-country, prospective safety study of pregnant women exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy. Women exposed to efgartigimod or efgartigimod PH20 SC only during breastfeeding will also be eligible to enroll. Background rates of major congenital malformations (MCMs) will be obtained from populations within the same countries/regions as the countries/regions in which the efgartigimod or efgartigimod PH20 SC exposed pregnancies were reported.
started
Nov 30, 2023
primary completion
Jan 1, 2033
completion
Dec 1, 2033
last updated
Feb 17, 2026
official title
A Worldwide Pregnancy Safety Study To Assess Maternal, Fetal, And Infant Outcomes Following Exposure To Efgartigimod During Pregnancy And/Or Breastfeeding
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol