EUCTR2017-001621-41-IT进行中（未招募）1 期
A phase III randomized study of doxycycline and tauroursodeoxycholic acid (Doxy/TUDCA) plus standard supportive therapy versus standard supportive therapy alone in cardiac amyloidosis caused by transthyretin - AmY-DoT
FONDAZIONE I.R.C.C.S. POLICLINICO SAN MATTEO0 个研究点目标入组 102 人开始时间: 2020年11月4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
- 102
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
- •- Diagnosis of ATTRwt amyloidosis, or ATTRm p.Ile68Leu and p.Val122Ile;
- •- 18 years or older;
- •- cardiac involvement (mean left ventricular wall thickness >12 mm in the absence of other causes);
- •- history of occurrence of at least 1 event of symptomatic heart failure;
- •- stable diuretic dosage for at least 2 weeks before treatment initiation;
- •- agree to practice effective methods of contraception where necessary
- •- voluntary written 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 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 66
排除标准
- •- Non-ATTR amyloidosis
- •- pregnant or nursing women
- •- uncontrolled bacterial, viral, fungal, HIV, HBV, or HCV infection;
- •- presence of other active malignancy with
- •- known allergy to tetracycline;
- •- treatment with drugs potentially affecting doxycycline absorption
- •- significant acute gastrointestinal symptoms;
- •- active peptic ulceration and/or esophageal reflux disease
研究者
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