Double-Blind, Placebo-Controlled, Randomized, Parallel Group, Multicenter Study to Evaluate Efficacy and Safety of 4 and 8 Million Units Betaferon®/Betaseron® (Interferon Beta-1b) Given Subcutaneously Every Other Day Over 24 Weeks in Patients With Chronic Viral Cardiomyopathy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 138
- 主要终点
- Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium
研究概览
简要总结
Chronic viral cardiomyopathy is a disease where the cardiac muscle is attacked by a virus and this may result in a reduction in the output of the heart (pump function) thereby causing complaints such as chest pain, shortness of breath and palpitations.
Betaferon (interferon beta-1b) is marketed for the treatment of Multiple Sclerosis already, but until now, it has not been proven whether it is also effective in patients with chronic viral myocardial disease.
This study will be conducted to examine the efficacy and safety of Betaferon in patients with this disease. The aim of the treatment is to eliminate the virus from the heart so that the heart function and clinical status can gradually improve.
详细描述
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.
Bayer Schering Pharma AG, Germany is the sponsor of the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unexplained heart with evidence of Adeno-, Entero- and/or Parvoviruses which must be identified directly in the heart tissue
- •Being in a chronic (at least 6 month after the onset of clinical symptoms) and stable phase of the disease
- •Impaired cardiac function
排除标准
- •Severe (decompensated) or acute heart failure.
- •Any other disease which could better explain the patient's clinical symptoms
- •Any other severe and/or malignant disease.
- •Suffering from convulsions, depression or suicidal ideas judged by a physician
- •Serious viral or bacterial infections during the last weeks
- •Pregnancy or lactation
研究组 & 干预措施
Arm 1
干预措施: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) (Drug)
Arm 2
干预措施: Interferon beta-1b (Betaferon/Betaseron, BAY86-5046) (Drug)
Arm 3
干预措施: Placebo (Drug)
Arm 4
干预措施: Placebo (Drug)
结局指标
主要结局
Presence of Adenovirus, Enterovirus and/or Parvovirus in endomyocardium
时间窗: 12 weeks after the end of a 24 weeks treatment
次要结局
- Hemodynamics(12 weeks after the end of treatment)
- Changes in NYHA functional class(12 weeks and 24 weeks after the end of treatment)
- Six-minute walking test(12 weeks and 24 weeks after the end of treatment)
- Single clinical symptoms (dyspnea, fatigue, palpitation, atypical angina and angina pectoris)(12 weeks and 24 weeks after the end of treatment)
- Quality of life(12 weeks and 24 weeks after the end of treatment)
- Left ventricular ejection fraction at rest and on exertion(12 weeks after the end of treatment)
- Regional and global wall motion, left ventricular enddiastolic diameter, and left ventricular endsystolic diameter(12 weeks after the end of treatment)
- Inflammatory state in endomyocardial biopsies(12 weeks after the end of treatment)
- Peripheral blood analyses for viral treatment effect and disease markers(12 weeks after the end of treatment)
- Composite clinical endpoint(12 weeks and 24 weeks after the end of treatment)