Overview

Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Acquired Hemophilia A

Status:
Terminated

Trial end date:
2011-08-01

Target enrollment:

Participant gender:

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 patient's blood that inhibits the effectiveness of their factor replacement product compared to treatment using cyclophosphamide. This is a Phase 2/3 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.

Phase:

Phase 2/Phase 3

Details

Lead Sponsor:

Georgetown University

Collaborator:

Genentech, Inc.

Treatments:

Antibodies
Cyclophosphamide
Factor VIII
Immunoglobulins
Prednisone
Rituximab