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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003539-68 | EudraCT Number |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bras A | Active Comparator | Steroid 1mg/kg/d and Cyclophosphamide 2mg/kg/d |
|
| Bras B | Experimental | Steroid 1mg/kg/d and Rituximab 375 mg/m2 every week during four weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steroid + cyclophosphamide | Drug |
| ||
| Steroid + rituximab |
| Measure | Description | Time Frame |
|---|---|---|
| Primary objective | 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 | During 18 months |
| Primary efficacy outcome | 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% | During 18 months |
| Primary safety outcomes | The primary safety outcomes will be the occurrence of major bleeding and infection related immunosuppressive treatment adverse events. | During 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary objective | 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 | 6 months, 12 months and 18 months |
| Other key safety outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Amiens | Amiens | 80054 | France | |||
| Hospital of Béziers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38555718 | Derived | Levesque H, Viallard JF, Houivet E, Bonnotte B, Voisin S, Le Cam-Duchez V, Maillot F, Lambert M, Liozon E, Hervier B, Fain O, Guillet B, Schmidt J, Luca LE, Ebbo M, Ferreira-Maldent N, Babuty A, Sailler L, Duffau P, Barbay V, Audia S, Benichou J, Graveleau J, Benhamou Y; CREHA Study investigators on behalf the scientific committee of the "Societe Nationale Francaise de Medecine Interne" (SNFMI - French National Society of Internal Medicine). Cyclophosphamide vs rituximab for eradicating inhibitors in acquired hemophilia A: A randomized trial in 108 patients. Thromb Res. 2024 May;237:79-87. doi: 10.1016/j.thromres.2024.03.012. Epub 2024 Mar 15. |
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The other key safety outcome are clinically relevant non major bleeding, diabetes and mortality non-related with acquired haemophilia or immunosuppressive therapy |
| During 18 months |
| Béziers |
| 34525 |
| France |
| Hospital Jean Verdier | Bondy | 93140 | France |
| Hospital Ambroise Paré | Boulogne-Billancourt | 92104 | France |
| University Hospital of Brest - Hospital La cavale Blanche | Brest | 29609 | France |
| University Hospital Côte de Nacre | Caen | 14033 | France |
| University Hospital G. Montpied | Clermont-Ferrand | 63003 | France |
| Hospital Henri Mondor | Créteil | 94010 | France |
| University Hospital of Dijon - Hospital Général | Dijon | 21033 | France |
| University Hospital Bocage | Dijon | 21079 | France |
| University Hospital Michallon | Grenoble | 38043 | France |
| Hospital Kremlin-Bicêtre | Le Kremlin-Bicêtre | 94270 | France |
| University Regional Hospital of Lille | Lille | 59037 | France |
| university Hospital of Limoges | Limoges | 87042 | France |
| AP-HM, University Hospital La Conception | Marseille | 13385 | France |
| University Hospital Saint-Eloi | Montpellier | 34295 | France |
| Regional Center of Haemophilia Treatment (CRTH) de Lorraine | Nancy | France |
| University Hospital of Nantes, Hospital Hôtel-Dieu | Nantes | 44093 | France |
| Hospital Archet 1 | Nice | 06202 | France |
| Hospital Bichat | Paris | 75018 | France |
| Hospital Saint-Louis | Paris | 75475 | France |
| Hospital Pitié-Salpêtrière | Paris | 75651 | France |
| Hospital Cochin | Paris | 75679 | France |
| Europen Hospital of Georges Pompidou (HEGP) | Paris | 75908 | France |
| University Hospital of Bordeaux - Hospital Haut-Lévêque | Pessac | 33604 | France |
| Hospital Lyon Sud | Pierre-Bénite | 69495 | France |
| University Hospital of Poitiers | Poitiers | 86021 | France |
| Hospital Sud / Hospital Pontchaillou | Rennes | 35000 | France |
| University Hospital of Rouen | Rouen | 76031 | France |
| Hospital Nord | Saint-Etienne | 42055 | France |
| University Regional Hospital Hautepierre | Strasbourg | 67098 | France |
| Hospital Purpan | Toulouse | 31059 | France |
| Hospital Rangueil | Toulouse | 31059 | France |
| Hopsital Bretonneau | Tours | 37044 | France |
| ID | Term |
|---|---|
| D013256 | Steroids |
| D003520 | Cyclophosphamide |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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