Back to results"Pharmacoepidemiological Evaluation of Autophagy Inhibition in Treatment of HCV Patients Resistant to Standard Therapy. Pilot Study"
Primary Purpose
Hepatitis C Virus
Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
150 mg/daily chloroquine compare to placebo for 12 week
Chloroquine
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C Virus
Eligibility Criteria
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
Sites / Locations
- Health Policy Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
chloroquine
placebo
Arm Description
150 mg chloroquine and lacebo , one tablet daily for 2 month
150 mg chloroquine and lacebo , one tablet daily for 2 month
Outcomes
Primary Outcome Measures
Loss of HCV RNA at end of treatment which is 8 weeks
Secondary Outcome Measures
Two log decrease in HCV RNA at the end of treatment
Full Information
NCT ID
NCT02058173
First Posted
February 5, 2014
Last Updated
October 18, 2015
Sponsor
Shiraz University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02058173
Brief Title
"Pharmacoepidemiological Evaluation of Autophagy Inhibition in Treatment of HCV Patients Resistant to Standard Therapy. Pilot Study"
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shiraz University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chloroquine
Arm Type
Experimental
Arm Description
150 mg chloroquine and lacebo , one tablet daily for 2 month
Arm Title
placebo
Arm Type
Experimental
Arm Description
150 mg chloroquine and lacebo , one tablet daily for 2 month
Intervention Type
Drug
Intervention Name(s)
150 mg/daily chloroquine compare to placebo for 12 week
Intervention Type
Drug
Intervention Name(s)
Chloroquine
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
Loss of HCV RNA at end of treatment which is 8 weeks
Time Frame
march 2014
Secondary Outcome Measure Information:
Title
Two log decrease in HCV RNA at the end of treatment
Time Frame
july 2014
Other Pre-specified Outcome Measures:
Title
ALT response which is significant decrease in ALT-(biochemical response during Treatment)
Time Frame
july 2014
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamran B Lankarani, M.D
Organizational Affiliation
Health policy research center
Official's Role
Study Chair
Facility Information:
Facility Name
Health Policy Research Center
City
Shiraz
State/Province
Fars
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
"Pharmacoepidemiological Evaluation of Autophagy Inhibition in Treatment of HCV Patients Resistant to Standard Therapy. Pilot Study"
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