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