Outcome of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab (CREHA Study)

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

Summary

CREHA project is a study comparing steroid combined with cyclophosphamide versus steroid combined with rituximab in patients with acquired haemophilia. The study will test the hypothesis that steroid combined with cyclophosphamide is more effective than steroid plus rituximab for FVIII inhibitor eradication in acquired haemophilia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Rouen
• Treatments: Cyclophosphamide; Rituximab

Criteria

Inclusion Criteria:

• men or women

• women post-menpausal or with ongoing contraception

• 18 years old or more

• diagnosis of acquired hemophilia

• patient must be insured

• patient has provided written informed consent prior to enrolment

• patient compliant

Exclusion Criteria:

• constitutional hemophilia

• chemotherapy

• ongoing treatment with prednisone > 20mg further more 1 month

• ongoing treatment with prednisone >0.7 mg/d further more 10 days

• thrombocytopenia

• leukopenia

• chronic disease