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

Information source: Shiraz University of Medical Sciences
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C Virus

Intervention: 150 mg/daily chloroquine compare to placebo for 12 week (Drug); Chloroquine (Drug); placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Shiraz University of Medical Sciences

Official(s) and/or principal investigator(s):
Kamran B Lankarani, M.D, Study Chair, Affiliation: Health policy research center

Overall contact:
Kamran Bagheri Lankarani, M.D, Phone: 098+-711-2309615, Email: lankarani@mohme.gov.ir


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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Loss of HCV RNA at end of treatment which is 8 weeks

Secondary outcome: Two log decrease in HCV RNA at the end of treatment


Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.


Inclusion Criteria:

- patients who failed to achieve a decline of 2 log HCV RNA IU/ml after 12 weeks of


- 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


- 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

Locations and Contacts

Kamran Bagheri Lankarani, M.D, Phone: 098+-711-2309615, Email: lankarani@mohme.gov.ir

Health Policy Research Center, Shiraz, Fars, Iran, Islamic Republic of; Recruiting
Kamran B Lankarani, M.D, Phone: 098-711-2309615, Email: lankarani@mohme.gov.ir
Additional Information

Starting date: January 2014
Last updated: March 12, 2014

Page last updated: August 20, 2015

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