NCT01913964已完成4 期
Acetyl-L-Carnitine Supplementation During HCV Therapy With Pegylated Interferon-α2b Plus Ribavirin
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 主要终点
- Work Productivity and Activity Impairment in workers with chronic hepatitis C
研究概览
简要总结
To assess the effects of Acetyl-L-Carnitine administration on work productivity, daily activity, and fatigue in subjects with chronic hepatitis C treated with Pegylated-Interferon-α2b and Ribavirin.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •workers who were 18 years of age or older
- •Workers who were infected by HCV and had a quantifiable serum HCV RNA level (as determined by polimerase chain reaction, COBAS AmpliPrep/COBAS TaqMan - ROCHE)
- •Cirrhotic workers with a Child-Pugh score less than 7
排除标准
- •workers who had other liver diseases
- •severe jaundice
- •pulmonary and renal chronic diseases,
- •prostatic diseases
- •autoimmune diseases
- •diabetes mellitus
- •decompensated cirrhosis
- •pregnancy
- •cardiopathy
- •hemoglobinopathies
- •hemocromatosis
- •major depression
- •severe psychiatric pathological conditions
研究组 & 干预措施
Acetyl-L-carnitine
Experimental
2 g daily for 12 months
干预措施: Acetylcarnitine (Drug)
placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Work Productivity and Activity Impairment in workers with chronic hepatitis C
时间窗: 12 months
Work productivity loss, impairment in daily activities, presenteeism, absenteeism, will be assessed using the Work Productivity and Activity Impairment questionnaire.
次要结局
- Fatigue in workers with chronic hepatitis C(12 months)
研究者
Mariano Malaguarnera
Associate Professor
University of Catania
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