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

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ClinicalTrials.gov Identifier: NCT01808911
Recruitment Status : Unknown
Verified May 2018 by University Hospital, Rouen.
Recruitment status was:  Recruiting
First Posted : March 11, 2013
Last Update Posted : May 29, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

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.

Condition or disease Intervention/treatment Phase
Acquired Haemophilia Drug: Steroid + cyclophosphamide Drug: Steroid + rituximab Phase 3

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outcome of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab (CREHA Study)
Actual Study Start Date : May 2012
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Active Comparator: Bras A
Steroid 1mg/kg/d and Cyclophosphamide 2mg/kg/d
Drug: Steroid + cyclophosphamide
Experimental: Bras B
Steroid 1mg/kg/d and Rituximab 375 mg/m2 every week during four weeks
Drug: Steroid + rituximab



Primary Outcome Measures :
  1. 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

  2. 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%

  3. 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.


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01808911


Contacts
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Contact: Hervé LEVESQUE, MD, PhD (0)2 32 88 90 01 ext +33 herve.levesque@chu-rouen.fr

Locations
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Sponsors and Collaborators
University Hospital, Rouen
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Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01808911    
Other Study ID Numbers: 2011/090/HP
First Posted: March 11, 2013    Key Record Dates
Last Update Posted: May 29, 2018
Last Verified: May 2018
Keywords provided by University Hospital, Rouen:
Acquired haemophilia
Comparative and randomized study
Cyclophosphamide
Rituximab
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Cyclophosphamide
Rituximab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological