Hepatitis C, Hepatitis C Virus
Conditions
Keywords
genotype 1 hepatitis C, hepatitis C, HCV, liver
Brief summary
This study seeks to evaluate the safety and efficacy of taking fluvastatin along with peginterferon alfa in previous partial responders with genotype 1 HCV.
Interventions
DRUGFluvastatin
Week 1: Fluvastatin 20mg daily Week 3: Fluvastatin 40mg daily Week 5: Fluvastatin 60mg daily Week 7: Fluvastatin 80 mg daily
180 mcg/ml SQ injection once a week for 48 weeks (starting at week 9)
DRUGribavirin
1000-1200 mg daily orally in two divided doses for 48 weeks (starting at week 9)
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female of any ethnicity age 18 - 65 years with genotype 1 HCV * Previous partial responder to attempts at HCV therapy with PEG/RBV (at least 1 log drop but less than 2 log drop in HCV RNA at 12 weeks) * Previous history or serum HCV-RNA PCR quantifiable by Roche Amplicore HCV Test * A liver biopsy within 3 years of study enrollment consistent with HCV disease. * Compensated liver disease, Child-Pugh Class ≤ 6 * Negative urine pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of the study drug * All patients enrolling in the study and all partners of study participants of childbearing potential must be using two reliable forms of effective contraception during the study. Exceptions may include partner/participant is surgically sterile. * Willingness to comply with study procedures and provide written informed consent
Exclusion criteria
* AST or ALT \> 10 ULN * Any investigational drug ≤ 12 weeks prior to the first of study drug * Prior intolerance to statin medications * Previous serious side effects to IFN or RBV (e.g. psychiatric side effect necessitating treatment discontinuation, severe cytopenia refractory to growth factors, intolerance to IFN/RBV requiring treatment discontinuation) * Any systemic antiviral therapy ≤ 24 weeks prior to the first dose of study drug or expectation that such treatment will be needed at any time during the study. Exception: Patients who have taken or are expected to require such treatment for herpetic lesions * Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc-IgM Ab ,or anti-HIV Ab * Serum concentrations of cerulplamin or alph-1-antitrypsin consistent with an increased risk of metabolic liver disease * History or other evidence of a medical condition associated with chronic liver disease (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure, nonalcoholic steatohepatitis) * Women who are pregnant or breastfeeding and male partners of woman who are pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy of adding fluvastatin to pegylated interferon alfa-2a and ribavirin in patients infected with genotype 1 HCV who are previous partial responders to standard treatment. | 18 months |
Secondary
| Measure | Time frame |
|---|---|
| Safety of adding fluvastatin to pegylated interferon alfa-2a and ribavirin in patients infected with genotype 1 HCV who are previous partial responders to standard treatment. | 18 months |
Outcome results
None listed