跳至主要内容
临床试验/NCT00493610
NCT00493610暂停不适用

Use of Mucomyst (NAC) to Ameliorate Oxidant Stress as Measured by Surrogate Serum in Patients With Hepatitis C

US Department of Veterans Affairs1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2006年11月最近更新:
适应症
干预措施
相关药物

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

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

Other

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)

研究者

申办方类型
Fed

研究点 (1)

Loading locations...

相似试验