Ignite Creation Date:
2024-05-06 @ 9:55 AM
Last Modification Date:
2024-10-26 @ 12:21 PM
Study NCT ID:
NCT03103555
Status:
UNKNOWN
Last Update Posted:
2017-04-06
First Post:
2017-04-01
Brief Title:
Treatment of Adult-Onset Immunodeficiency With Bortezomib
Sponsor:
Mahidol University
Organization:
Mahidol University
Study Overview
Official Title:
Treatment of Anti-Interferon-Gamma Autoantibody Associated Acquired Immunodeficiency Syndrome With Bortezomib Pilot Study
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
RECRUITING
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 is pilot study aimed to investigate the application of proteosome inhibitor Bortezomib in treatment of patients with neutralizing autoantibody to IFN-γ The investigators hypothesis is that bortezomib will reduce the antibody level and restore interferon-gamma function resulting in clinical improvement and should be well-tolerated and safe for use in patients with autoantibody to IFN-γ
Detailed Description:
The patients with autoantibody to IFN-γ and past or current history of proven opportunistic infection will receive 2 treatment cycles of bortezomib subcutaneously 4 injections of 13 mg Bortezomib m2 body surface per cycle followed by low dose oral cyclophosphamide for 4 month after completion treatment with bortezomib
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None