Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607627
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-19
Brief Title:
PK PD Safety and Efficacy Study of Gefurulimab in Pediatric Patients With AChR Generalized Myasthenia Gravis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-Label Single-arm Study to Evaluate the Pharmacokinetics PK Pharmacodynamics PD Safety and Efficacy of Gefurulimab in Pediatric Patients 6 to 18 Years of Age With Generalized Myasthenia Gravis gMG Who Express Acetylcholine Receptor Antibodies AChR
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to assess the pharmacokinetics and pharmacodynamics of gefurulimab in pediatric participants with AChR gMG for the duration of the study
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