"Pharmacoepidemiological Evaluation of Autophagy Inhibition in Treatment of HCV Patients Resistant to Standard Therapy. Pilot Study"
- Conditions
- Hepatitis C Virus
- Interventions
- Registration Number
- NCT02058173
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo 150 mg/daily chloroquine compare to placebo for 12 week 150 mg chloroquine and lacebo , one tablet daily for 2 month chloroquine 150 mg/daily chloroquine compare to placebo for 12 week 150 mg chloroquine and lacebo , one tablet daily for 2 month placebo placebo 150 mg chloroquine and lacebo , one tablet daily for 2 month chloroquine Chloroquine 150 mg chloroquine and lacebo , one tablet daily for 2 month
- Primary Outcome Measures
Name Time Method Loss of HCV RNA at end of treatment which is 8 weeks march 2014
- Secondary Outcome Measures
Name Time Method Two log decrease in HCV RNA at the end of treatment july 2014
Trial Locations
- Locations (1)
Health Policy Research Center
🇮🇷Shiraz, Fars, Iran, Islamic Republic of