Chronic Hepatitis C
Conditions
Keywords
chronic hepatitis C, interferon
Brief summary
Objective: The goal is to improve peginterferon sensitivity in previous poor responders. Sensitivity here means the host's ability to kill more HCV. Design: Twenty poor responders to prior PIFN/RBV will be given 48 weeks of statin monotherapy. Veterans and civilians between the ages of 18 and 70 are eligible.
Interventions
DRUGstatin
daily statin orally for 48 weeks
Sponsors
Bader, Ted, M.D.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Hepatitis C positive by HCV RNA within 180 days. - No anti-HCV medicine within 30 days of screening
Exclusion criteria
* decompensated liver disease * severe cardiac disease (ejection fraction \< 20% or uncontrolled angina) * unexplained muscle pain at time of screening * pregnancy * renal insufficiency (creatine clearance \< 50 ml/min)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in peginterferon response as measured by change in HCV RNA levels | 48 weeks | The change in hepatitis C viral load in response to one injection of peginterferon will be measured with a baseline pre-study viral load and response to an injection of peginterferon; this test will be remeasured 48 weeks later. The change in viral loads over time will be assessed statistically. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The response of interferon stimulated genes | 48 weeks | The number of known interferon activated genes will be assessed by microarray from serum samples at baseline and then reassessed by microarray 48 weeks later. |
Countries
United States
Outcome results
None listed