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

October 18, 2015 updated by: Payam Peymani, Shiraz University of Medical Sciences
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: chloroquine
150 mg chloroquine and lacebo , one tablet daily for 2 month
Drug: Chloroquine
Drug: 150 mg/daily chloroquine compare to placebo for 12 week
Experimental: placebo
150 mg chloroquine and lacebo , one tablet daily for 2 month
Drug: placebo
Drug: 150 mg/daily chloroquine compare to placebo for 12 week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Loss of HCV RNA at end of treatment which is 8 weeks
Time Frame: march 2014
march 2014

Secondary Outcome Measures

Outcome Measure
Time Frame
Two log decrease in HCV RNA at the end of treatment
Time Frame: july 2014
july 2014

Other Outcome Measures

Outcome Measure
Time Frame
ALT response which is significant decrease in ALT-(biochemical response during Treatment)
Time Frame: july 2014
july 2014

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Investigators

  • Study Chair: Kamran B Lankarani, M.D, Health Policy Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

February 5, 2014

First Submitted That Met QC Criteria

February 6, 2014

First Posted (Estimate)

February 7, 2014

Study Record Updates

Last Update Posted (Estimate)

October 20, 2015

Last Update Submitted That Met QC Criteria

October 18, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP7-92 (Registry Identifier: HP7-92)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C Virus

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe