"Pharmacoepidemiological Evaluation of Autophagy Inhibition in Treatment of HCV Patients Resistant to Standard Therapy. Pilot Study"
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Loss of HCV RNA at end of treatment which is 8 weeks
研究概览
简要总结
The purpose of this study is to assess the efficacy of Chloroquine comparing with placebo for treatment of non- response HCV patients.. In this triple blind pilot study, 20 patients with confirmed chronic hepatitis C will be randomize into treatment group (Chloroquine 150 mg daily, for 8 weeks) or control group (placebo once daily, for 8 weeks). Patients who have receiving anti neoplastic, anti viral or Immunomedullator drugs during 6 months prior to study, have co-infection Hepatitis A,C,D or HIV, severe liver or renal dysfunction, are pregnant or breast fed, or refuse to sign informed consent will be excluded.. At the end of therapy (12 weeks) and at baseline, first, second and third month after receiving drug and placebo HCV Virus load, CBC LFT and biochemical parameters will be evaluated and compared between groups.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who failed to achieve a decline of 2 log HCV RNA IU/ml after 12 weeks of treatment
- •who never achieved undetectable HCV RNA during treatment of a minimum duration of 24 weeks
排除标准
- •Receiving anti neoplasm, anti viral or immunomedulator drugs during 6 months prior to study
- •coinfection with Hepatitis A,C,D viruses or HIV
- •Severe dysfunction of liver and kidney
- •pregnancy
- •breast feeding
- •refusing to give informed consent
- •active Alcohol user
- •presence of decompensate cirrhosis
研究组 & 干预措施
chloroquine
150 mg chloroquine and lacebo , one tablet daily for 2 month
干预措施: 150 mg/daily chloroquine compare to placebo for 12 week (Drug)
chloroquine
150 mg chloroquine and lacebo , one tablet daily for 2 month
干预措施: Chloroquine (Drug)
placebo
150 mg chloroquine and lacebo , one tablet daily for 2 month
干预措施: 150 mg/daily chloroquine compare to placebo for 12 week (Drug)
placebo
150 mg chloroquine and lacebo , one tablet daily for 2 month
干预措施: placebo (Drug)
结局指标
主要结局
Loss of HCV RNA at end of treatment which is 8 weeks
时间窗: march 2014
次要结局
- Two log decrease in HCV RNA at the end of treatment(july 2014)
研究者
Payam Peymani
PhD Student of pharmacoepidemiology,health policy reseach center,Shiraz University of Medical Sciences
Shiraz University of Medical Sciences