EUCTR2009-009463-61-NL进行中（未招募）1 期
Controlled trail of immunoglobulin therapy for patients with idiopathic cardiomyopathy and endomyocardial parvovirus B19 persistence - - a prospective, double-blind, randomized, placebo-controlled clinical trial. - IVIg for PVB19 mediated cardiomyopathy
Sanquin Plasma Products0 个研究点目标入组 50 人开始时间: 2009年4月2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
- 50
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
- •- Symptomatic idiopathic cardiomyopathy >6months.
- •- Optimal conventional heart failure medication <3 months.
- •- PVB19 viral load >200 copies/mcg DNA in endomyocardial biopsies (EMBs)
- •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
- •- Other causes for heart failure
- •oSignificant coronary artery disease (lesions >70 % stenosis).
- •oSignificant valvular disease
- •oUntreated hypertension (blood pressure >140mmHg)
- •oSubstance abuse
- •oChemotherapy induced
- •- Pregnancy or lactation
- •- Systemic diseases such as sarcoidosis, giant cell myocarditis, hemochromatosis, or
- •systemic autoimmune diseases.
- •- Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study
- •- Known with allergic reactions against human plasma or plasma products
- •- Having an ongoing progressive terminal disease, including HIV infection
- •- Having renal insufficiency (plasma creatinin >115µmol/L or creatinin clearance <20 ml/min)
- •- Having an ongoing active disease causing general symptoms e.g. chronic active hepatitis, persistent enterovirus infection with ongoing systemic complaints
- •- Having detectable anti-IgA antibodies
- •- Active SLE
研究者
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