ACTRN12613000721707
Completed
Phase 2
A Multicentre, single arm, open label study evaluating the efficacy and safety of Eltrombopag (Revolade TM)) in patients with early refractory Immune Thrombocytopenia within 6 months of diagnosis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Immune Thrombocytopenia
- Sponsor
- Alfred Health
- Enrollment
- 39
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •ALL of the following criteria must be met to be eligible:
- •1\. Documented diagnosis of ITP (by exclusion) according to the ASH guidelines,
- •2\. Age greater than or equal to 18 years,
- •3\. Primary refractory ITP with a platelet count less than 30x109/L despite an average daily dose of at least 1mg/kg (or 75mg in patients greater than 75kg) prednisolone for at least 2 weeks OR
- •Recurrent ITP after an initial response to steroids which requires 10mg or more of prednisolone per day and, or, recurrent doses of IVIG to maintain a platelet count of 30x109/L or greater (within 6 months of diagnosis, noting that above this threshold, steroid toxicity with prolonged therapy is unacceptable).
- •4\.Failure of prior splenectomy will NOT be an inclusion criteria, noting that (a) splenectomy will not be appropriate in some patients due to surgical risk and (b) particularly in younger patients, avoiding splenectomy may be desirable if the natural history of acute ITP in a subset is ultimately to resolve
- •Patients with ITP fulfilling the above criteria in the setting of HIV with CD4 count greater than 0\.5x109/L undetectable viral load are eligible, as will be patients with secondary causes of ITP such as auto\-immune disorders, lymphoproliferative disease and hepatitis C, subject to the exclusion criteria below.
Exclusion Criteria
- •Patients presenting with any of the following will be excluded from the study:
- •1\.Failure or inability to provide informed consent.
- •2\.Geographic inaccessibility prohibiting follow\-up.
- •3\.Treatment with rituximab within 8 weeks prior to consent.
- •4\.Predicted survival of less than 12 months.
- •5\.Patients with multisystem autoimmune disease, lymphoproliferative disorders or hepatitis C anticipated who receive disease specific therapy within the first 12 weeks (e.g., chemotherapy, cyclophosphamide, anti\-viral therapy)
- •6\.Drug\-induced thrombocytopenia.
- •7\.Known hypersensitivity to thrombopoietin Receptor agonists.
- •8\.Pregnant or breast\-feeding.
- •9\.Reproductive potential but not willing to adhere to adequate contraception from screening and for one year after first dose of Eltrombopag.
Outcomes
Primary Outcomes
Not specified
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