Clinical trial NCT01808911: Outcome of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab (CREHA Study)
Official title: Outcome of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab (CREHA Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acquired Haemophilia
Keywords: Acquired haemophilia
Comparative and randomized study
Cyclophosphamide
Rituximab
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2013-03-11
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Primary objective
timeFrame: During 18 months
measure: Primary efficacy outcome
timeFrame: During 18 months
measure: Primary safety outcomes
timeFrame: During 18 months
Secondary outcomes:
measure: Secondary objective
timeFrame: 6 months, 12 months and 18 months
measure: Other key safety outcome
timeFrame: During 18 months
Other outcomes:
Locations:
city: Amiens
country: France
facility: University Hospital Amiens
city: Bondy
country: France
facility: Hospital Jean Verdier
city: Boulogne-Billancourt
country: France
facility: Hospital Ambroise Paré
city: Brest
country: France
facility: University Hospital of Brest - Hospital La cavale Blanche
city: Béziers
country: France
facility: Hospital of Béziers
city: Caen
country: France
facility: University Hospital Côte de Nacre
city: Clermont-Ferrand
country: France
facility: University Hospital G. Montpied
city: Créteil
country: France
facility: Hospital Henri Mondor
city: Dijon
country: France
facility: University Hospital of Dijon - Hospital Général
city: Dijon
country: France
facility: University Hospital Bocage
city: Grenoble
country: France
facility: University Hospital Michallon
city: Le Kremlin-bicetre
country: France
facility: Hospital Kremlin-Bicêtre
city: Lille
country: France
facility: University Regional Hospital of Lille
city: Limoges
country: France
facility: university Hospital of Limoges
city: Marseille
country: France
facility: AP-HM, University Hospital La Conception
city: Montpellier
country: France
facility: University Hospital Saint-Eloi
city: Nancy
country: France
facility: Regional Center of Haemophilia Treatment (CRTH) de Lorraine
city: Nantes
country: France
facility: University Hospital of Nantes, Hospital Hôtel-Dieu
city: Nice
country: France
facility: Hospital Archet 1
city: Paris 10e
country: France
facility: Hospital Saint-Louis
city: Paris 13e
country: France
facility: Hospital Pitié-Salpêtrière
city: Paris 14e
country: France
facility: Hospital Cochin
city: Paris 18e
country: France
facility: Hospital Bichat
city: Paris
country: France
facility: Europen Hospital of Georges Pompidou (HEGP)
city: Pessac
country: France
facility: University Hospital of Bordeaux - Hospital Haut-Lévêque
city: Pierre-Benite
country: France
facility: Hospital Lyon Sud
city: Poitiers
country: France
facility: University Hospital of Poitiers
city: Rennes
country: France
facility: Hospital Sud / Hospital Pontchaillou
city: Rouen
country: France
facility: University Hospital of Rouen
city: Saint-Etienne
country: France
facility: Hospital Nord
city: Strasbourg
country: France
facility: University Regional Hospital Hautepierre
city: Toulouse
country: France
facility: Hospital Purpan
city: Toulouse
country: France
facility: Hospital Rangueil
city: Tours
country: France
facility: Hopsital Bretonneau
Study officials:
References: