ACTRN12611000015943尚未招募不适用
Efficacy, safety and tolerability of combination therapy with high dose dexamethasone, low dose rituximab and cyclosporine in patients with primary immune thrombocytopenic purpura (ITP)
Professor Beng Hock Chong0 个研究点目标入组 15 人开始时间: 2011年1月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
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
- •Primary ITP as diagnosed according to IWG guidelines (Provan et, 2010)
- •Platelet count <30x10^9/L or 30-50x10^9/L with either 1. evidence of ongoing bleeding secondary to thrombocytopenia or 2. treatment dependence including corticosteroids, IVIG, second-line immunosuppressants and TPO-agonists.
- •Fully informed written consent
排除标准
- •Treatment in the last 6 months with combination therapy of high dose corticosteroids (methylprednisolone >30mg/kg/day for 3 days or high dose dexamethasone 40mg/day for 4 days) and either anti-CD 20 antibody (rituximab) or anti-T cell therapy with cyclosporine or mycophenolate mofetil
- •Active malignant disease - except BCC or SCC of skin
- •Untreated hepatitis B infection
- •Active opportunistic infection or untreated tuberculosis
- •Life expectancy of less than 12 months
- •Moderate-severe renal impairment (eGFR<50mL/min)
- •Poorly controlled hypertension (BP>140/80)
- •Pregnancy in females of child-bearing age
研究者
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