"Pharmacoepidemiological Evaluation of Autophagy Inhibition in Treatment of HCV Patients Resistant to Standard Therapy. Pilot Study"

Phase 4CompletedNCT02058173

Shiraz University of Medical Sciences10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hepatitis C Virus

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Loss of HCV RNA at end of treatment which is 8 weeks

Time frame: march 2014

Secondary Outcomes

Two log decrease in HCV RNA at the end of treatment

Time frame: july 2014