ACTRN12613000721707已完成2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 39
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
- •10.HIV with CD4 count less than 500 and detectable viral load.
- •11.Symptomatic clinical significant arterial or venous thrombosis within 6 weeks prior to consent. Note that patients requiring anti-platelet or anti-thrombotic therapy for an event prior to 6 weeks will be eligible, with the intention that this therapy will be resumed once the platelet count reaches an appropriate level (in the order of 50x109/L for most patients). However, patients at very high risk of thrombosis e.g., antiphospholipid syndrome with prior thromboses or multiple thrombophilia risk factors will not be eligible
- •12.Participation in another clinical trial with any investigational drug within 30 days prior to study screening.
研究者
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