A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.

Part of paid clinical trials in Morgantown, West Virginia.

Sponsor
argenx
Study ID
NCT06299748
Status
Recruiting
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Conditions

  • CIDP - Chronic Inflammatory Demyelinating Polyneuropathy
  • Myasthenia Gravis

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Efgartigimod — BIOLOGICAL
    Efgartigimod IV or SC

Study Details

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.

Key Dates

Start date
Nov 30, 2023
Status verified
Feb 2026
Primary completion
Jan 31, 2033
Completion
Dec 31, 2033

Study Design

Enrollment
279 participants (estimated)

Arms

  • Arm: Retrospective Pregnancy
    woman is no longer pregnant at time of study enrollment but was exposed to efgartigimod or efgartigimod PH20 SC any time within 25 days prior to conception or any time during pregnancy
  • Arm: Prospective Pregnancy
    woman is pregnant or breastfeeding at time of study enrollment.

Primary Outcome Measure

Pregnancy outcomes [ Time Frame: up to 10 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
United BioSource LLCMorgantownWest Virginia26508
Sabine Coppieters, MD
[email protected]
857-350-4834

Find similar trials in Morgantown, WV

By research site
United BioSource LLC· Morgantown, WV

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