Trials / Recruiting
RecruitingNCT06299748
A Worldwide Pregnancy Safety Study to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy and/or Breastfeeding.
A Worldwide Pregnancy Safety Study To Assess Maternal, Fetal, And Infant Outcomes Following Exposure To Efgartigimod During Pregnancy And/Or Breastfeeding
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 279 (estimated)
- Sponsor
- argenx · Industry
- Sex
- Female
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Efgartigimod | Efgartigimod IV or SC |
Timeline
- Start date
- 2023-11-30
- Primary completion
- 2033-01-01
- Completion
- 2033-12-01
- First posted
- 2024-03-08
- Last updated
- 2026-02-17
Locations
4 sites across 4 countries: United States, Germany, Italy, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06299748. Inclusion in this directory is not an endorsement.