Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06299748
Status:
RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-02-22
Brief Title:
A Worldwide Pregnancy Safety Study to Assess Maternal Fetal and Infant Outcomes Following Exposure to Efgartigimod During Pregnancy andor Breastfeeding
Sponsor:
argenx
Organization:
argenx
Study Overview
Official Title:
A Worldwide Pregnancy Safety Study To Assess Maternal Fetal And Infant Outcomes Following Exposure To Efgartigimod During Pregnancy AndOr Breastfeeding
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-country prospective safety study of pregnant women exposed to efgartigimod any time within 25 days prior to conception or any time during pregnancy Women exposed to efgartigimod only during breastfeeding will also be eligible to enroll Background rates of major congenital malformations MCMs will be obtained from populations within the same countriesregions as the countriesregions in which the VYVGART IV or SC-exposed pregnancies were reported
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None