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A Randomised Phase III Study of the Efficacy of High Dose Dexamethasone Versus High Dose Dexamethasone in Combination With Rituximab (MabThera®)in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)
In this study we want to investigate if combination therapy with rituximab (R) + dexamethasone (DXM) is superior to monotherapy with DXM in patients with newly diagnosed idiopathic thrombocytopenic purpura (ITP). Before treatment molecular studies - gene expression profiling - are performed to characterize at the molecular level those patients responding adequately to the treatment as compared to those obtaining a minor or no responses. The hypothesis is that combination therapy is superior to monotherapy as defined above. Using gene expression studies up-front the hypothesis is that this method may be able to predict the response to treatment.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Aalborg Hospital
Aalborg, Denmark
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark
Esbjerg Hospital
Esbjerg, Denmark
Copenhagen University Hospital Herlev, Department of Haematology
Herlev, Denmark
Regional Hospital Holstebro
Holstebro, Denmark
Naestved Hospital
Næstved, Denmark
Odense University Hospital
Odense, Denmark
Roskilde Hospital
Roskilde, Denmark
Vejle Hospital
Vejle, Denmark
Viborg Hospital
Viborg, Denmark
Start Date
August 1, 2004
Primary Completion Date
June 1, 2012
Completion Date
August 1, 2017
Last Updated
September 10, 2019
155
ACTUAL participants
Dexamethasone
DRUG
Dexamethasone and Rituximab
DRUG
Lead Sponsor
Copenhagen University Hospital at Herlev
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