Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04833894
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2021-03-16
Brief Title:
Evaluating the Pharmacokinetics Pharmacodynamics and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis
Sponsor:
argenx
Organization:
argenx
Study Overview
Official Title:
Open-label Uncontrolled Trial to Evaluate Pharmacokinetics Pharmacodynamics Safety and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The purpose of this trial is to investigate the PK PD safety and activity of efgartigimod IV in children and adolescents aged from 2 to less than 18 years of age with gMG
Trial details include
The maximum trial duration for each individual participant will be approximately 28 weeks
The treatment duration will be 8 weeks for the dose-confirmatory part Part A and 18 weeks for the treatment response-confirmatory part Part B
Trial details include
The maximum trial duration for each individual participant will be approximately 28 weeks
The treatment duration will be 8 weeks for the dose-confirmatory part Part A and 18 weeks for the treatment response-confirmatory part Part B
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