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

Acquired Haemophilia Clinical Trial

— CREHA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01808911
• Other study ID #: 2011/090/HP
• Status: Recruiting
• Phase: Phase 3
• Start date: May 2012
• Est. completion date: June 2020

Study information

• Verified date: May 2018
• Source: University Hospital, Rouen
• Contact: Hervé LEVESQUE, MD, PhD
• Phone: (0)2 32 88 90 01
• Email: herve.levesque[@]chu-rouen.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Haemophilia
• Hemophilia A

Intervention

Drug:
• Steroid + cyclophosphamide

• Steroid + rituximab

Locations

Country	Name	City	State
France	University Hospital Amiens	Amiens
France	Hospital of Béziers	Béziers
France	Hospital Jean Verdier	Bondy
France	Hospital Ambroise Paré	Boulogne-Billancourt
France	University Hospital of Brest - Hospital La cavale Blanche	Brest
France	University Hospital Côte de Nacre	Caen
France	University Hospital G. Montpied	Clermont-Ferrand
France	Hospital Henri Mondor	Créteil
France	University Hospital Bocage	Dijon
France	University Hospital of Dijon - Hospital Général	Dijon
France	University Hospital Michallon	Grenoble
France	Hospital Kremlin-Bicêtre	Le Kremlin-bicetre
France	University Regional Hospital of Lille	Lille
France	university Hospital of Limoges	Limoges
France	AP-HM, University Hospital La Conception	Marseille
France	University Hospital Saint-Eloi	Montpellier
France	Regional Center of Haemophilia Treatment (CRTH) de Lorraine	Nancy
France	University Hospital of Nantes, Hospital Hôtel-Dieu	Nantes
France	Hospital Archet 1	Nice
France	Europen Hospital of Georges Pompidou (HEGP)	Paris
France	Hospital Saint-Louis	Paris 10e
France	Hospital Pitié-Salpêtrière	Paris 13e
France	Hospital Cochin	Paris 14e
France	Hospital Bichat	Paris 18e
France	University Hospital of Bordeaux - Hospital Haut-Lévêque	Pessac
France	Hospital Lyon Sud	Pierre-Benite
France	University Hospital of Poitiers	Poitiers
France	Hospital Sud / Hospital Pontchaillou	Rennes
France	University Hospital of Rouen	Rouen
France	Hospital Nord	Saint-Etienne
France	University Regional Hospital Hautepierre	Strasbourg
France	Hospital Purpan	Toulouse
France	Hospital Rangueil	Toulouse
France	Hopsital Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Primary safety outcomes	The primary safety outcomes will be the occurrence of major bleeding and infection related immunosuppressive treatment adverse events.	During 18 months
Secondary	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
Secondary	Other key safety outcome	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