Clinical trial NCT00814606: A Pilot Trial to Determine the Safety and Efficacy of Fluvastatin in Previous Partial Responders to Pegylated Interferon and Ribivirin in Patients With Genotype 1 Hepatitis C
Official title: A Pilot Trial to Determine the Safety and Efficacy of Fluvastatin in Previous Partial Responders to Pegylated Interferon and Ribivirin in Patients With Genotype 1 Hepatitis C
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hepatitis C
Hepatitis C Virus
Keywords: genotype 1 hepatitis C
hepatitis C
HCV
liver
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2008-12-25
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 18 months
Secondary outcomes:
measure: 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.
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Chicago
name: K Gautham Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: