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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatitis C Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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chloroquine

150 mg chloroquine and lacebo , one tablet daily for 2 month

Group Type EXPERIMENTAL

150 mg/daily chloroquine compare to placebo for 12 week

Intervention Type DRUG

Chloroquine

Intervention Type DRUG

placebo

150 mg chloroquine and lacebo , one tablet daily for 2 month

Group Type EXPERIMENTAL

150 mg/daily chloroquine compare to placebo for 12 week

Intervention Type DRUG

placebo

Intervention Type DRUG

Interventions

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150 mg/daily chloroquine compare to placebo for 12 week

Intervention Type DRUG

Chloroquine

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No