ISRCTN68399350已完成2 期
A randomised trial for the Treatment of cardiac AMyloid light-chain amyloidosis with the green tea compound Epigallocatechin-3-gALlate (TAME-AL)
Ruprecht-Karls-University of Heidelberg (Germany)0 个研究点目标入组 38 人开始时间: 2012年10月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Biopsy proven systemic AL amyloidosis
- •2. Cardiac involvement with septum thickness >12 mm (without other causes as published by Gertz et al)
- •3. Hypertension or other potential causes of left ventricular hypertrophy
- •4. Previously treated with chemotherapy
- •5. Induced at least a very good partial remission of the underlying monoclonal plasma cell or B cell disorder
排除标准
- •1. Age < 18 years
- •2. Concomitant multiple myeloma stage II and III (Salmon and Durie)
- •3. Concurrent chemotherapy necessary
- •4. Time to last chemotherapy > 6 months
- •5. Chronic liver disease
- •6. Bilirubin > 1,5 mg/dl
- •7. Not able to visit Amyloidosis Clinic in Heidelberg every 3 months
研究者
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