Ignite Creation Date:
2024-05-06 @ 2:53 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04450654
Status:
WITHDRAWN
Last Update Posted:
2022-10-24
First Post:
2020-06-24
Brief Title:
Monotherapy IVIG Gamunex-C for HMG-CoA Reductase Auto-Antibody Positive Necrotizing Myopathy Treatment The MIGHT Trial
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Monotherapy IVIG Gamunex-C for HMG-CoA Reductase Auto-Antibody Positive Necrotizing Myopathy Treatment The MIGHT Trial
Status:
WITHDRAWN
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No Participants Enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 2 pilot randomized placebo-controlled trial of Gamunex-C IVIG as mono-therapy for HMGCoA reductase auto-antibody positive HMGCR necrotizing myopathy The trial will test the feasibility and initial efficacy of Gamunex-C IVIG mono-therapy in HMGCR necrotizing myopathy
Detailed Description:
This is a phase 2 double-blinded randomized placebo-controlled multi-center trial of Gamunex-C IVIG as mono-therapy for HMGCR necrotizing myopathy Up to 10 treatment-naïve patients will be enrolled and randomized to receive either Gamunex-C IVIG dosed at 2gkg or placebo at week 0 and week 4 The primary efficacy outcome is the percentage of patients at week 8 with at least minimal improvement per the 2016 ACREULAR myositis clinical response criteria
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