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

Sponsor: University Hospital, Rouen
Study ID: NCT01808911
Phase: PHASE3
Status: Completed

Conditions

Acquired Haemophilia

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Steroid + cyclophosphamide — DRUG
Steroid + rituximab — DRUG

Study Details

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.

Key Dates

Start date: May 31, 2012
Status verified: Mar 2026
Primary completion: Jan 14, 2021
Completion: Jan 14, 2021

Study Design

Enrollment: 110 participants (actual)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Active Comparator: Bras A
Steroid 1mg/kg/d and Cyclophosphamide 2mg/kg/d
Experimental: Bras B
Steroid 1mg/kg/d and Rituximab 375 mg/m2 every week during four weeks

Primary Outcome Measure

Primary objective [ Time Frame: During 18 months ]