Hepatitis C Virus
Conditions
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.
Interventions
DRUG150 mg/daily chloroquine compare to placebo for 12 week
DRUGChloroquine
DRUGplacebo
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Loss of HCV RNA at end of treatment which is 8 weeks | march 2014 |
Secondary
| Measure | Time frame |
|---|---|
| Two log decrease in HCV RNA at the end of treatment | july 2014 |
Other
| Measure | Time frame |
|---|---|
| ALT response which is significant decrease in ALT-(biochemical response during Treatment) | july 2014 |
Countries
Iran
Outcome results
None listed