Actively Recruiting
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
Led by argenx · Updated on 2026-02-17
279
Participants Needed
4
Research Sites
522 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women exposed to efgartigimod or efgartigimod PH20 SC anytime within 25 days before conception, during pregnancy, or during breastfeeding
- Ability to provide written or verbal informed consent or eConsent; for adolescents under age of majority, assent or eConsent by the pregnant minor and consent by parent/legal guardian as applicable
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
United BioSource LLC
Morgantown, West Virginia, United States, 26508
Actively Recruiting
2
Klinikum der Ruhr-Universität Bochum St. Josef Hospital Neurologische Interdisziplinäre Infusionsambulanz + MS Studienambulanz (Haus E Ebene1)
Bochum, Germany, 44791
Actively Recruiting
3
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
4
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Actively Recruiting
Research Team
S
Sabine Coppieters, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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