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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

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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