A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
Key facts
- Where
- Roma, ItalySee the site
Where in Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- argenx
- Trial code
- NCT06299748
- Record updated
- 17 February 2026
- Original description
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.Read full original descriptionShow less
A Worldwide Pregnancy Safety Study To Assess Maternal, Fetal, And Infant Outcomes Following Exposure To Efgartigimod During Pregnancy And/Or Breastfeeding
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.
Inclusion: Women with exposure to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy, or women with exposure to efgartigimod or efgartigimod PH20 SC during breastfeeding. The timeframe of 25 days prior to conception is calculated based on five times the efgartigimod half-life, which is 3 to 5 days; Written/verbal informed consent or eConsent (depending on country regulations) (for adolescents under the age of majority, written/verbal informed assent or eConsent by the pregnant minor (where applicable) and written/verbal informed consent or eConsent by the parent/legal guardian).
Exclusion: None.