Status:
COMPLETED
The Efficacy of Dexamethasone Versus Dexamethasone Combined With Rituximab in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)
Lead Sponsor:
Copenhagen University Hospital at Herlev
Conditions:
Idiopathic Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 pu...
Eligibility Criteria
Inclusion
- Age 18 years or over
- Diagnosis = ITP + platelet count above or equal to 25 Mia/l or platelet count above or equal to 50 Mia/l and bleeding from the mucous membranes.
- Adequate contraceptive measures within the last 3 months for women of childbearing potential.
Exclusion
- Performance status above or equal to 2
- Previous treatment with rituximab
- Immunosuppressive treatment within the last month except for not previously treated patients
- Other serious disease
- Pregnant women and nursing mothers
- Contraindication for rituximab treatment.
- Active infection requiring antibiotic treatment.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT00909077
Start Date
August 1 2004
End Date
August 1 2017
Last Update
September 10 2019
Active Locations (10)
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1
Aalborg Hospital
Aalborg, Denmark, DK-9000
2
Copenhagen University Hospital Rigshospitalet
Copenhagen, Denmark, DK-2100
3
Esbjerg Hospital
Esbjerg, Denmark, DK-6700
4
Copenhagen University Hospital Herlev, Department of Haematology
Herlev, Denmark, DK-2730