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Fluoroquinolones as anti-HCV drugs

Phase 1
Conditions
Hepatitis C virus infection.
Chronic viral hepatitis C
Registration Number
IRCT2014102619678N1
Lead Sponsor
Higher Education Commission, Pakistan
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
40
Inclusion Criteria

•Patient on IFN treatment who have not shown two-log reduction in their HCV load for 3 months
•HCV-RNA positive
•Infection with HCV genotype 3a
•Chronic hepatitis diagnosed by liver ultrasound
•Pre-cirrhotic, as determined by liver ultrasound
•Informed consent to participate in the study

Exclusion criteria:
•Known hypersensitivity to fluoroquinolones
•Infection with HCV genotype other than 3a
•Pregnant females
•Concurrent hepatitis B or HIV infection
•Carcinomatous changes on liver biopsy evident in liver ultrasound
•History of alcohol or intravenous drug abuse
•Disinclination to informed consent

Exclusion Criteria

Not provided

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Viral load. Timepoint: 3 months post drug treatment. Method of measurement: Quantitative Real Time PCR for viral RNA.
Secondary Outcome Measures
NameTimeMethod
iver function test and Complete Blood Count. Timepoint: Weekly throughout the drug treatment. Method of measurement: Clinical laboratory using automated testing units and microscopy.
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