Ignite Creation Date:
2024-05-05 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00306670
Status:
TERMINATED
Last Update Posted:
2017-02-10
First Post:
2006-03-23
Brief Title:
Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Acquired Hemophilia A
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
A Prospective Phase IIIII Randomized Mult-institutional Controlled Open-label Phase II Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Patients With Acquired Hemophilia A
Status:
TERMINATED
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor no longer funding study
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 study is to evaluate the rate of response when administering rituximab to suppress or eliminate the anti-body in a patients blood that inhibits the effectiveness of their factor replacement product compared to treatment using cyclophosphamide This is a Phase 23 study to find out what effects good and bad and response rituximab has on a patient and their anti-Factor VIII antibodies Also to compare the effect good and bad of the rituximab with cyclophosphamide on a patient and their anti-Factor VIII antibodies to see which is better This research is being done because we do not know which treatment regimen rituximab or cyclophosphamide is more effective in eliminating or suppressing the anti-Factor VIII antibody in patients with acquired Hemophilia A
Detailed Description:
This is a prospective Phase II randomized multi-institutional controlled pilot trial comparing the regimen of single agent rituximab with 6 weeks cytotoxic therapy with oral cyclophosphamide to eradicate or suppress autoimmune anti-factor VIII antibodies in individuals with acquired hemophilia A Patients will be randomized to receive either of these two regimens when their autoimmune anti-factor VIII antibodies prove to be refractory to initial upfront immunosuppressive treatment with oral prednisone 1 mgkgday or equivalent corticosteroid doses for 3 weeks Patients will be randomized to the treatment cohorts according to the biostatistical methods
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