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

Last updated: May 25, 2018
Sponsor: University Hospital, Rouen
Overall Status: Active - Recruiting

Phase

3

Condition

Hemophilia

Treatment

N/A

Clinical Study ID

NCT01808911
2011/090/HP
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 164
Study Start date:
May 01, 2012
Estimated Completion Date:
June 30, 2020

Study 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

Connect with a study center

  • University Hospital Amiens

    Amiens, 80054
    France

    Active - Recruiting

  • Hospital Jean Verdier

    Bondy, 93140
    France

    Active - Recruiting

  • Hospital Ambroise Paré

    Boulogne-Billancourt, 92104
    France

    Active - Recruiting

  • University Hospital of Brest - Hospital La cavale Blanche

    Brest, 29609
    France

    Active - Recruiting

  • Hospital of Béziers

    Béziers, 34525
    France

    Active - Recruiting

  • University Hospital Côte de Nacre

    Caen, 14033
    France

    Active - Recruiting

  • University Hospital G. Montpied

    Clermont-Ferrand, 63003
    France

    Active - Recruiting

  • Hospital Henri Mondor

    Créteil, 94010
    France

    Active - Recruiting

  • University Hospital Bocage

    Dijon, 21079
    France

    Active - Recruiting

  • University Hospital of Dijon - Hospital Général

    Dijon, 21033
    France

    Active - Recruiting

  • University Hospital Michallon

    Grenoble, 38043
    France

    Active - Recruiting

  • Hospital Kremlin-Bicêtre

    Le Kremlin-bicetre, 94270
    France

    Active - Recruiting

  • University Regional Hospital of Lille

    Lille, 59037
    France

    Active - Recruiting

  • university Hospital of Limoges

    Limoges, 87042
    France

    Active - Recruiting

  • AP-HM, University Hospital La Conception

    Marseille, 13385
    France

    Active - Recruiting

  • University Hospital Saint-Eloi

    Montpellier, 34295
    France

    Active - Recruiting

  • Regional Center of Haemophilia Treatment (CRTH) de Lorraine

    Nancy,
    France

    Site Not Available

  • University Hospital of Nantes, Hospital Hôtel-Dieu

    Nantes, 44093
    France

    Active - Recruiting

  • Hospital Archet 1

    Nice, 06202
    France

    Site Not Available

  • Europen Hospital of Georges Pompidou (HEGP)

    Paris, 75908
    France

    Active - Recruiting

  • Hospital Saint-Louis

    Paris 10e, 75475
    France

    Site Not Available

  • Hospital Pitié-Salpêtrière

    Paris 13e, 75651
    France

    Active - Recruiting

  • Hospital Cochin

    Paris 14e, 75679
    France

    Site Not Available

  • Hospital Bichat

    Paris 18e, 75018
    France

    Active - Recruiting

  • University Hospital of Bordeaux - Hospital Haut-Lévêque

    Pessac, 33604
    France

    Active - Recruiting

  • Hospital Lyon Sud

    Pierre-Benite, 69495
    France

    Active - Recruiting

  • University Hospital of Poitiers

    Poitiers, 86021
    France

    Active - Recruiting

  • Hospital Sud / Hospital Pontchaillou

    Rennes, 35000
    France

    Active - Recruiting

  • University Hospital of Rouen

    Rouen, 76031
    France

    Active - Recruiting

  • Hospital Nord

    Saint-Etienne, 42055
    France

    Active - Recruiting

  • University Regional Hospital Hautepierre

    Strasbourg, 67098
    France

    Active - Recruiting

  • Hospital Purpan

    Toulouse, 31059
    France

    Active - Recruiting

  • Hospital Rangueil

    Toulouse, 31059
    France

    Active - Recruiting

  • Hopsital Bretonneau

    Tours, 37044
    France

    Active - Recruiting

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