Trial Outcomes & Findings for Trial of Rituximab Versus Oral Cyclophosphamide to Eradicate or Suppress Autoimmune Anti-Factor VIII Antibodies in Acquired Hemophilia A (NCT NCT00306670)

Results Overview

the 2 recruited patients did not eradicate their inhibitors with 3 weeks of corticosteroids and did not progress in clinical trial since funding was eliminated and study terminated

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

2 participants

Primary outcome timeframe

When 25 patients have completed the study.

Results posted on

2017-02-10

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	0	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study patients recruited; Genentech, the st	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rituximab Patients will receive rituximab. Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies prednisone: \<30 mg/day	Oral Cyclophosphamide n=2 Participants Patients will receive oral cyclophosphamide. prednisone: \<30 mg/day	Total n=2 Participants Total of all reporting groups
Age, Continuous	—	60 years n=7 Participants	60 years n=5 Participants
Gender Female	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Gender Male	—	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	—	2 participants n=7 Participants	2 participants n=5 Participants
factor VIII activity; factor VIII inhibitor titer	—	25 units on a scale n=7 Participants	25 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: When 25 patients have completed the study.

Population: 2 patients with acquired hemophilia A: two patients were recruited, but the sponsor terminated the study before the patients started treatment

the 2 recruited patients did not eradicate their inhibitors with 3 weeks of corticosteroids and did not progress in clinical trial since funding was eliminated and study terminated

Outcome measures

Outcome measures
Measure	Rituximab Patients will receive rituximab. Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies prednisone: \<30 mg/day	Oral Cyclophosphamide n=2 Participants Patients will receive oral cyclophosphamide. prednisone: \<30 mg/day
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.	—	0 Participants

Adverse Events

Rituximab

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Oral Cyclophosphamide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Craig M Kessler, MD

Georgetown University

Phone: 202-444-8676

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place