Use of Mucomyst (NAC) to Ameliorate Oxidant Stress as Measured by Surrogate Serum in Patients With Hepatitis C
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Measurable oxidant stress
研究概览
简要总结
The study will examine the effects of treatment with N-acetylcysteine ( Mucomyst ) 1 gm twice a day for 30 dyas in 15 patients with hepatitis C. The primary outcome of interest wil be the changes in oxidant stress as measured by different oxidant stress markers level in sera. Secondary outcomes of interest will be changes in viral load of hep C and changes in liver function
详细描述
The Effects of N-Acetylcysteine on Oxidative Stress in Chronic Hepatitis C
Objective:
There is evidence that suggests oxidative stress plays a role in the pathologic mechanism of disease progression in chronic hepatitis C virus infection (HCV). This study will test the hypothesis that N-acetylcysteine given over one month will decrease oxidative stress and thus slow disease progression.
Background:
Chronic hepatitis C is the most common blood borne infection in the United States. An average of 230,000 new infections occurred each year during the 1980s, although since 1989 the annual number of new infections has declined by greater than 80% to 36,000 by 1996.1,2,3 A CDC survey in 2003 showed that annual new cases had declined to 30,000.4 The Third National Health and Nutrition Examination Survey (NHANES III), conducted during 1988-1994, indicated that an estimated 3.9 million (1.8%) Americans have been infected with HCV. In the general population, the highest prevalence rates of HCV infection are found among persons aged 30-49 years and among males. Unlike the racial/ethnic pattern of acute disease, African Americans have a substantially higher prevalence of HCV infection than do whites.5 Population-based studies indicate that 40% of chronic liver disease is HCV-related, resulting in estimated deaths of 8,000-10,000 each year. According to the CDC, estimated medical and work-loss costs of HCV-related acute and chronic liver disease are greater than $600 million annually, and HCV-associated end-stage liver disease is the most frequent indication for liver transplantation among adults.1
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with known hepatitis C
排除标准
- •Patient on another therapy for Hep C
- •Patient on dialysis
- •Patient who are allergic to Mucomyst
研究组 & 干预措施
1
干预措施: N-acetylcysteine(Mucomyst) (Drug)
结局指标
主要结局
Measurable oxidant stress
时间窗: 30 days
次要结局
- Reduction in viral load of Hep C and changes in Liver Function tests(30 days)
