Skip to main content
OpenTrials
Completed

NCT Number: NCT02058173

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Virus Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Health Policy Research Center

Shiraz, Fars, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

150 mg/daily chloroquine compare to placebo for 12 week

Drug

Chloroquine

Drug

Placebo

Drug

Primary outcomes

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

    Time frame: march 2014

Secondary outcomes

  1. Two log decrease in HCV RNA at the end of treatment

    Time frame: july 2014

Other outcomes

  1. ALT response which is significant decrease in ALT-(biochemical response during Treatment)

    Time frame: july 2014

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 7, 2014
Registry last updated
Oct 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.