A multi centre, open label study to evaluate efficacy and safety of 1000 mg of rituximab on day 1 and 15 in patients with idiopathic thrombocytopenic purpura
- Conditions
- Idopathic Thrombocytopenic PurpuraBlood - Other blood disorders
- Registration Number
- ACTRN12607000297426
- Lead Sponsor
- Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 108
Documented diagnosis of Idiopathic Thrombocytopaenic Purpura (ITP) according to the American Society of Haematology (ASH) guidelines:
1. Chronic ITP requiring ongoing corticosteroid and/or immunosuppressive therapy (e.g. dexamethasone, prednisolone, danazol, azathioprine and/or cyclophosphamide) for more than 3 months to maintain platelet count >30x10^9/L. Patients must have a documented platelet count of >30x10^9/L and = 50x10^9/L within 7 days prior to first infusion.
OR
2. ITP in relapse (> or = 1) (defined as a platelet count = 30x10^9/L), with first relapse occurring within 12 months of initial diagnosis and second relapse at any time thereafter. Patients must have a documented platelet count = 30x10^9/L and >10x10^9/L within 7 days prior to first infusion.
1. ITP diagnosed less than 6 weeks prior to consent.
2. Prior treatment with rituximab.
3. Multisystem autoimmune disease.
4. Lymphoproliferative disorders.
5. Drug-induced thrombocytopenia.
6. Pregnant or breast-feeding.
7. Human Immunodeficiency Virus (HIV) serology positive.
8. Hepatitis B or Hepatitis C serology positive (unless due to vaccination).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate based on platelet count as determined by blood tests (full blood count).[Measured 8 weeks after day 1.]
- Secondary Outcome Measures
Name Time Method Duration of response[Measured monthly from week 8 up to 52 weeks.];Safety [As reported by patients at weekly study visits up to week 8]