EUCTR2006-007091-15-NL进行中(未招募)不适用
Glivec (imatinib mesylate) in systemic sclerosis, a pilot study - Glivec in systemic sclerosis
ErasmusMC0 个研究点目标入组 10 人开始时间: 2007年4月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •·Patients with systemic sclerosis (either diffuse or limited) refractory to standard therapy
- •·Adequate end organ function, defined as: total bilirubin <1.5 x ULN, SGOT and SGPT < 2.5 x ULN (or <5 x ULN if hepatic disease involvement is present), creatinine < 1.5 x ULN, ANC >1.5 x 109/L, platelets > 100 x 109/L.
- •·Adequate anticonception in women
- •·Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·Age < 18 years
- •·Previous or current malignancy
- •·Current treatment with endothelin receptor antagonist
- •·Current treatment with immunosuppressive drugs
- •·Life expectancy < 6 months
- •·Inability to adhere to the current protocol
研究者
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