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

NCT02058173 | Completed Phase 4 DMC

• 1 other identifier: HP7-92
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C Virus

Outcome Measures

Primary Outcomes (1)

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

  march 2014

Secondary Outcomes (1)

• Two log decrease in HCV RNA at the end of treatment

  july 2014

Other Outcomes (1)

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

  july 2014

Study Arms (2)

chloroquine

EXPERIMENTAL

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

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

placebo

EXPERIMENTAL

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

Drug: 150 mg/daily chloroquine compare to placebo for 12 week; Drug: placebo

Interventions

150 mg/daily chloroquine compare to placebo for 12 week DRUG

chloroquine; placebo

Chloroquine DRUG

chloroquine

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

Study Sites (1)

Health Policy Research Center

Shiraz, Fars, Iran

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Chloroquine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kamran B Lankarani, M.D

  Health policy research center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student of pharmacoepidemiology,health policy reseach center,Shiraz University of Medical Sciences

Study Record Dates

• First Submitted: February 5, 2014
• First Posted: February 7, 2014
• Study Start: January 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: October 20, 2015

Record last verified: 2015-10

Locations

IR (1)