Skip to main content
OpenTrials
Completed

NCT Number: NCT01808911

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acquired Haemophilia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Amiens, Amiens, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Steroid + cyclophosphamide

Drug

Steroid + rituximab

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Acronym: CREHA

Important dates

Study start
2012
Primary completion
2021
Study completion
2021
First posted
Mar 11, 2013
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.