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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary: 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
Sponsor: University Hospital, Rouen

Current Primary Outcome:

  • Primary objective [ Time Frame: During 18 months ]
    Demonstrate the inferiority of steroid combined with rituximab as compared to the recommended immunosuppressive approach (steroid combined with cysclophosphamide for 21 to 42 days) as the first-line immunosuppressive therapy for FVIII inhibitor eradication in acquired haemophilia
  • Primary efficacy outcome [ Time Frame: During 18 months ]
    The primary efficacy outcome is the proportion of patients achieving complete remission defined as titer FVII inhibitor lower than 0.4 Bethesda unit and factor VIII level > 50%
  • Primary safety outcomes [ Time Frame: During 18 months ]
    The primary safety outcomes will be the occurrence of major bleeding and infection related immunosuppressive treatment adverse events.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Secondary objective [ Time Frame: 6 months, 12 months and 18 months ]
    Secondary objective are time to complete remission, number of relapse at M6, M12, M18, adverse events (especially related to bleeding or to immunosuppressive treatment) and mortality
  • Other key safety outcome [ Time Frame: During 18 months ]
    The other key safety outcome are clinically relevant non major bleeding, diabetes and mortality non-related with acquired haemophilia or immunosuppressive therapy


Original Secondary Outcome: Same as current

Information By: University Hospital, Rouen

Dates:
Date Received: October 16, 2012
Date Started: May 2012
Date Completion: November 2018
Last Updated: November 18, 2016
Last Verified: November 2016