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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00814606
• Other study ID #: 16336A
• Status: Withdrawn
• Phase: Phase 2
• First received: December 23, 2008
• Last updated: June 28, 2013
• Start date: February 2010
• Est. completion date: October 2010

Study information

• Verified date: June 2013
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes