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

University Hospital, Rouen

Status and phase: Completed; Phase 3

Conditions: Acquired Haemophilia

Treatments: Drug: Steroid + rituximab; Drug: Steroid + cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT01808911

2011/090/HP

Details and patient eligibility

About

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.

Full description

CREHA project is a multicenter, randomized, controlled efficacity and safety 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

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 2 patient groups

Bras A

Active Comparator group

Description:

Steroid 1mg/kg/d and Cyclophosphamide 2mg/kg/d

Treatment:

Drug: Steroid + cyclophosphamide

Bras B

Experimental group

Description:

Steroid 1mg/kg/d and Rituximab 375 mg/m2 every week during four weeks

Treatment:

Drug: Steroid + rituximab