NL-OMON33416已完成3 期
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 Plasmaproducten0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* Symptomatic idiopathic cardiomyopathy >6 months
- •* Optimal conventional heart failure medication ><=3 months
- •* PVB19 viral load >200 copies/mcg DNA in endomyocardial biopsies
- •* Signed informed consent
- •* Age between 18 and 75 years
排除标准
- •* Other causes for heart failure:
- •o Significant coronary artery disease (lesions >70 % stenosis).
- •o Significant valvular disease
- •o Untreated hypertension (blood pressure >140mmHg)
- •o Substance abuse
- •o Chemotherapy induced
- •*Significant titer of other cardiotrophic viruses (EV, ADV, HHV6, EBV)
- •*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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