The R- 100 ITP Study : evaluating the efficacy of a single weekly dose of 100mg of Rituximab over 4 weeks in patients with refractory or relapsing idiopathic thrombocytopaenic purpura
Phase 2
Recruiting
- Conditions
- Idiopathic thrombocytopaenic purpuraBlood - Haematological diseases
- Registration Number
- ACTRN12612000591853
- Lead Sponsor
- Florence Peterson Fund
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Aged over 18 years
Refractory ITP defined as a platelet count of <30 despite 8 weeks of standard ITP therapy
ITP that has relapsed post splenectomy
Exclusion Criteria
Aged <18 years
ITP diagnosed <8 weeks
Prior Rituximab therapy
HIV infection
SLE associated
Lymphoproliferative associated
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the ORR of the Rituximab dose used by physical examination and measuring the platelet count to see if it has responded to the therapy.[Assess at weeks 8,16,26 and 52 and 24 months]
- Secondary Outcome Measures
Name Time Method Safety profile and any infection problems by physical examination and clinical questions.[Weeks 8, 16, 26 and 52 weeks and also at 24 months]