Ignite Creation Date:
2024-05-06 @ 3:50 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777734
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2022-04-29
First Post:
2021-02-26
Brief Title:
Efgartigimod Expanded Access for Generalized Myasthenia Gravis
Sponsor:
argenx
Organization:
argenx
Study Overview
Official Title:
An Expanded Access Program for Efgartigimod Treatment in Patients With Generalized Myasthenia Gravis
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2022-04
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 expanded access protocol applies to patients with gMG who are not enrolled in an ongoing clinical trial The aim of the trial is to provide patients with generalized myasthenia gravis gMG who are ineligible to participate in a clinical trial access to efgartigimod treatment before regulatory approval
There are country-specific protocols and also individual use EAP Recruitment for the treatment protocol in US is now closed ARGX-113-EAP-2101
There are country-specific protocols and also individual use EAP Recruitment for the treatment protocol in US is now closed ARGX-113-EAP-2101
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None