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

This study has been terminated.
(Sponsor no longer funding study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00306670
First Posted: March 24, 2006
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Craig Kessler, Georgetown University
Results First Submitted: December 20, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hemophilia A
Interventions: Drug: Rituxan
Drug: prednisone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rituximab

Patients will receive rituximab.

Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies

prednisone: <30 mg/day

Oral Cyclophosphamide

Patients will receive oral cyclophosphamide.

prednisone: <30 mg/day


Participant Flow:   Overall Study
    Rituximab   Oral Cyclophosphamide
STARTED   0 [1]   2 [2] 
COMPLETED   0 [1]   0 [3] 
NOT COMPLETED   0   2 
patients recruited; Genentech, the st                0                2 
[1] no patients recruited; Genentech, the study sponsor, pulled funding and discontinued the protocol
[2] 2 patients recruited; Genentech, the study sponsor, discontinued trial before treatment started
[3] 2 patients recruited; Genentech, the study sponsor, discontinued study before treatment initiated



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Patients diagnosed with acquired FVIII inhibitors were to be randomized to Rituximab versus oral cyclophosphamide to evaluate efficacy of inhibitor eradication and safety

Reporting Groups
  Description
Rituximab

Patients will receive rituximab.

Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies

prednisone: <30 mg/day

Oral Cyclophosphamide

Patients will receive oral cyclophosphamide.

prednisone: <30 mg/day

Total Total of all reporting groups

Baseline Measures
   Rituximab   Oral Cyclophosphamide   Total 
Overall Participants Analyzed 
[Units: Participants]
 0   2   2 
Age 
[Units: Years]
Mean (Full Range)
    60 
 (52 to 68) 
 60 
 (52 to 68) 
Gender 
[Units: Participants]
Count of Participants
     
Female         1  50.0%      1  50.0% 
Male         1  50.0%      1  50.0% 
Region of Enrollment 
[Units: Participants]
     
United States      2   2 
factor VIII activity; factor VIII inhibitor titer 
[Units: Units on a scale]
Mean (Full Range)
    25 
 (5 to 30) 
 25 
 (5 to 30) 


  Outcome Measures

1.  Primary:   To Evaluate the Total Number of Circulating Lymphocytes and Lymphocyte Phenotypes and to Correlate With the Effectiveness of Rituximab and Oral Cyclophosphamide to Achieve and Preserve Complete Eradication of the Refractory Autoantibody.   [ Time Frame: When 25 patients have completed the study. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Sponsor terminated study prior to patient receiving first dose of study drug.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Craig M Kessler, MD
Organization: Georgetown University
phone: 202-444-8676
e-mail: kesslerc@georgetown.edu



Responsible Party: Craig Kessler, Georgetown University
ClinicalTrials.gov Identifier: NCT00306670     History of Changes
Other Study ID Numbers: U2688
First Submitted: March 23, 2006
First Posted: March 24, 2006
Results First Submitted: December 20, 2016
Results First Posted: February 10, 2017
Last Update Posted: February 10, 2017