CompletedPhase 3

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

France110 participantsStarted 2012-05

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Primary objective

Timeframe: During 18 months

Primary efficacy outcome

Timeframe: During 18 months

Primary safety outcomes

Timeframe: During 18 months

Trial details

NCT IDNCT01808911

SponsorUniversity Hospital, Rouen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-01-14

View on ClinicalTrials.gov More Acquired Haemophilia trials