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

This study seeks to evaluate the safety and efficacy of taking fluvastatin along with peginterferon alfa in previous partial responders with genotype 1 HCV.

Study Overview

• Status: Withdrawn
• Conditions: Hepatitis C; Hepatitis C Virus
• Intervention / Treatment: Drug: Fluvastatin; Drug: Peginterferon alfa2a; Drug: ribavirin

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single Group; 8 weeks period of escalating doses of fluvastatin to a goal dose of 80mg daily, then patients will start treatment of HCV at week 9 with the usual standard of care protocol for medication dose, office visits and laboratories. Peginterferon alfa2a 180 mcg/ml SQ injection once a week for 48 weeks and ribavirin 1000-1200 mg daily orally in two divided doses for 48 weeks. Patients weighing < 75 kg will receive 1000mg per day (400mg in the morning and 600mg in the evening). Patients weighing ≥ 75 kg will receive 1200 mg per day (600mg in the morning and 600 mg in the evening).

Drug: Fluvastatin; Week 1: Fluvastatin 20mg daily Week 3: Fluvastatin 40mg daily Week 5: Fluvastatin 60mg daily Week 7: Fluvastatin 80 mg daily; Drug: Peginterferon alfa2a; 180 mcg/ml SQ injection once a week for 48 weeks (starting at week 9); Other Names: Pegasys; Drug: ribavirin; 1000-1200 mg daily orally in two divided doses for 48 weeks (starting at week 9); Other Names: Copegus

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: K Gautham Reddy, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: December 23, 2008
• First Submitted That Met QC Criteria: December 24, 2008
• First Posted (Estimate): December 25, 2008

Study Record Updates

• Last Update Posted (Estimate): July 1, 2013
• Last Update Submitted That Met QC Criteria: June 28, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: HCV; liver; hepatitis C; genotype 1 hepatitis C
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Ribavirin; Peginterferon alfa-2a
• Other Study ID Numbers: 16336A