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

Last updated: October 2, 2025
Sponsor: University Hospital, Rouen
Overall Status: Completed

Phase

3

Condition

Hemophilia

Treatment

Steroid + rituximab

Steroid + cyclophosphamide

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: 110
Treatment Group(s): 2
Primary Treatment: Steroid + rituximab
Phase: 3
Study Start date:
May 01, 2012
Estimated Completion Date:
January 14, 2021

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

    Site Not Available

  • University Hospital Amiens

    Amiens 3037854, 80054
    France

    Site Not Available

  • Hospital Jean Verdier

    Bondy, 93140
    France

    Site Not Available

  • Hospital Jean Verdier

    Bondy 3031815, 93140
    France

    Site Not Available

  • Hospital Ambroise Paré

    Boulogne-Billancourt, 92104
    France

    Site Not Available

  • Hospital Ambroise Paré

    Boulogne-Billancourt 3031137, 92104
    France

    Site Not Available

  • University Hospital of Brest - Hospital La cavale Blanche

    Brest, 29609
    France

    Site Not Available

  • University Hospital of Brest - Hospital La cavale Blanche

    Brest 3030300, 29609
    France

    Site Not Available

  • Hospital of Béziers

    Béziers, 34525
    France

    Site Not Available

  • Hospital of Béziers

    Béziers 3032833, 34525
    France

    Site Not Available

  • University Hospital Côte de Nacre

    Caen, 14033
    France

    Site Not Available

  • University Hospital Côte de Nacre

    Caen 3029241, 14033
    France

    Site Not Available

  • University Hospital G. Montpied

    Clermont-Ferrand, 63003
    France

    Site Not Available

  • University Hospital G. Montpied

    Clermont-Ferrand 3024635, 63003
    France

    Site Not Available

  • Hospital Henri Mondor

    Créteil, 94010
    France

    Site Not Available

  • Hospital Henri Mondor

    Créteil 3022530, 94010
    France

    Site Not Available

  • University Hospital Bocage

    Dijon, 21079
    France

    Site Not Available

  • University Hospital of Dijon - Hospital Général

    Dijon, 21033
    France

    Active - Recruiting

  • University Hospital Bocage

    Dijon 3021372, 21079
    France

    Site Not Available

  • University Hospital of Dijon - Hospital Général

    Dijon 3021372, 21033
    France

    Site Not Available

  • University Hospital Michallon

    Grenoble, 38043
    France

    Site Not Available

  • University Hospital Michallon

    Grenoble 3014728, 38043
    France

    Site Not Available

  • Hospital Kremlin-Bicêtre

    Le Kremlin-Bicêtre 3003737, 94270
    France

    Site Not Available

  • Hospital Kremlin-Bicêtre

    Le Kremlin-bicetre, 94270
    France

    Site Not Available

  • University Regional Hospital of Lille

    Lille, 59037
    France

    Site Not Available

  • University Regional Hospital of Lille

    Lille 2998324, 59037
    France

    Site Not Available

  • university Hospital of Limoges

    Limoges, 87042
    France

    Site Not Available

  • university Hospital of Limoges

    Limoges 2998286, 87042
    France

    Site Not Available

  • AP-HM, University Hospital La Conception

    Marseille, 13385
    France

    Site Not Available

  • AP-HM, University Hospital La Conception

    Marseille 2995469, 13385
    France

    Site Not Available

  • University Hospital Saint-Eloi

    Montpellier, 34295
    France

    Site Not Available

  • University Hospital Saint-Eloi

    Montpellier 2992166, 34295
    France

    Site Not Available

  • Regional Center of Haemophilia Treatment (CRTH) de Lorraine

    Nancy,
    France

    Site Not Available

  • Regional Center of Haemophilia Treatment (CRTH) de Lorraine

    Nancy 2990999,
    France

    Site Not Available

  • University Hospital of Nantes, Hospital Hôtel-Dieu

    Nantes, 44093
    France

    Site Not Available

  • University Hospital of Nantes, Hospital Hôtel-Dieu

    Nantes 2990969, 44093
    France

    Site Not Available

  • Hospital Archet 1

    Nice, 06202
    France

    Site Not Available

  • Hospital Archet 1

    Nice 2990440, 06202
    France

    Site Not Available

  • Europen Hospital of Georges Pompidou (HEGP)

    Paris, 75908
    France

    Site Not Available

  • Europen Hospital of Georges Pompidou (HEGP)

    Paris 2988507, 75908
    France

    Site Not Available

  • Hospital Saint-Louis

    Paris 10 Entrepôt 3020216, 75475
    France

    Site Not Available

  • Hospital Saint-Louis

    Paris 10e, 75475
    France

    Site Not Available

  • Hospital Pitié-Salpêtrière

    Paris 13 Gobelins 3015772, 75651
    France

    Site Not Available

  • Hospital Pitié-Salpêtrière

    Paris 13e, 75651
    France

    Site Not Available

  • Hospital Cochin

    Paris 14 Observatoire 2989781, 75679
    France

    Site Not Available

  • Hospital Cochin

    Paris 14e, 75679
    France

    Site Not Available

  • Hospital Bichat

    Paris 18 Buttes-Montmartre 3029374, 75018
    France

    Site Not Available

  • Hospital Bichat

    Paris 18e, 75018
    France

    Site Not Available

  • University Hospital of Bordeaux - Hospital Haut-Lévêque

    Pessac, 33604
    France

    Site Not Available

  • University Hospital of Bordeaux - Hospital Haut-Lévêque

    Pessac 2987805, 33604
    France

    Site Not Available

  • Hospital Lyon Sud

    Pierre-Benite, 69495
    France

    Site Not Available

  • Hospital Lyon Sud

    Pierre-Bénite 2987314, 69495
    France

    Site Not Available

  • University Hospital of Poitiers

    Poitiers, 86021
    France

    Site Not Available

  • University Hospital of Poitiers

    Poitiers 2986495, 86021
    France

    Site Not Available

  • Hospital Sud / Hospital Pontchaillou

    Rennes, 35000
    France

    Site Not Available

  • Hospital Sud / Hospital Pontchaillou

    Rennes 2983990, 35000
    France

    Site Not Available

  • University Hospital of Rouen

    Rouen, 76031
    France

    Site Not Available

  • University Hospital of Rouen

    Rouen 2982652, 76031
    France

    Site Not Available

  • Hospital Nord

    Saint-Etienne, 42055
    France

    Site Not Available

  • Hospital Nord

    Saint-Etienne 2980291, 42055
    France

    Site Not Available

  • University Regional Hospital Hautepierre

    Strasbourg, 67098
    France

    Site Not Available

  • University Regional Hospital Hautepierre

    Strasbourg 2973783, 67098
    France

    Site Not Available

  • Hospital Purpan

    Toulouse, 31059
    France

    Active - Recruiting

  • Hospital Rangueil

    Toulouse, 31059
    France

    Site Not Available

  • Hospital Purpan

    Toulouse 2972315, 31059
    France

    Site Not Available

  • Hospital Rangueil

    Toulouse 2972315, 31059
    France

    Site Not Available

  • Hopsital Bretonneau

    Tours, 37044
    France

    Site Not Available

  • Hopsital Bretonneau

    Tours 2972191, 37044
    France

    Site Not Available

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