EUCTR2017-002210-31-DE进行中（未招募）1 期
A randomized phase II/III trial of doxycycline vs. standard supportive therapy in newly-diagnosed cardiac AL amyloidosis patients undergoing bortezomib-based therapy - ReDox
Amyloid Center - Biotechnology Research Laboratories Policlinico San Matteo0 个研究点目标入组 120 人开始时间: 2019年1月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •newly-diagnosed AL amyloidosis
- •stage II/IIIa heart involvement
- •age >18 years
- •planned bortezomib-based therapy
- •total bilirubin <1.5 × upper reference limit (url),
- •patients with Gilbert disease who have a total bilirubin,
- •predominantly unconjugated >1.5 × url without any other
- •liver function test abnormalities are still eligible
- •alkaline phosphatase <5 × url
- •alanine aminotransferase <3 × url
- •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 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •non-AL amyloidosis
- •· previous treatment for AL amyloidosis
- •· pregnant or nursing women
- •· uncontrolled infection
- •· active malignancy
- •· known hypersensitivity to doxycycline, bortezomib, boron,
- •or mannitol
- •· treatment with drugs potentially affecting doxycycline
- •· significant acute gastrointestinal symptoms
- •· active peptic ulceration and/or esophageal reflux disease
- •· contraindications to bortezomib based therapy
研究者
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