NCT06299748Recruiting
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
argenx
Start Date
11/30/2023
Completion Date
12/1/2033
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.
Eligibility Criteria
Age Range: No minimum to No maximum
Inclusion Criteria:
* 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 Criteria:
* None
Interventions
BIOLOGICAL
Efgartigimod
Conditions
Myasthenia GravisCIDP - Chronic Inflammatory Demyelinating Polyneuropathy
Locations
United BioSource LLC
Morgantown, West Virginia 26508
United States
Klinikum der Ruhr-Universität Bochum St. Josef Hospital Neurologische Interdisziplinäre Infusionsambulanz + MS Studienambulanz (Haus E Ebene1)
Bochum, 44791
Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Italy
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain