Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06587867
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Seronegative Myasthenia Gravis - Efgartigimod IV
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy Safety and Tolerability of Efgartigimod in Patients with Seronegative Generalized Myasthenia Gravis an Open-Label Study
Status:
RECRUITING
Status Verified Date:
2024-08
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:
This is to study the efficacy safety and tolerability of efgartigimod in patients with seronegative generalized myasthenia gravis This is an open label study There will be 30 participants to enroll at University Health Network Toronto General Hospital Study duration is 43 weeks from screening to end of study
Detailed Description:
There will be screening period that includes ECG safety blood collection collection of demographics vital signs questionnaires weight pregnancy test if applicable genetic test If eligible participants will have run-in period from week 2 to week 5 Baseline is at week 6 Induction phase will be weekly from week 7 8 and 9 Maintenance phase will be once every 2 weeks thereafter Observation period will have 4 visits End of study is at week 43
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