A Randomized, Partially-blind Study to Evaluate the Safety, Tolerability and Effect on Virological Response of Treatment with the HCV Protease Inhibitor RO5190591 in combination with Pegasys and Copegus for 12 or 24 weeks, versus treatment with Pegasys and Copegus alone, in Treatment-Naïve Patients with Chronic Hepatitis C Genotype 1 Virus Infection

F.Hoffmann-La Roche0 sites300 target enrollmentSeptember 8, 2009

Overview

No summary available.

Registry

who.int

Start Date

September 8, 2009

End Date

January 2, 2012

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

F.Hoffmann-La Roche

•1\. Age 18 years and older
•2\. Serologic evidence of CHC infection by an anti\-HCV antibody test (current or historical)
•3\. Evidence of chronic hepatitis C infection \> 6 months duration
•4\. Evidence of hepatitis C genotype 1 infection by molecular assay
•5\. Serum HCV RNA quantifiable at \= 50,000 IU/mL as demonstrated by the Roche COBAS TaqMan HCV Test
•6\. HCV treatment\-naïve (i.e. have never received treatment for CHC, including but not
•limited to IFN\-based therapy, ribavirin, or other anti\-viral agents with established or
•perceived activity against the HCV virus)
•7\. Liver biopsy within the past 24 months showing clear absence of advanced fibrosis
•or cirrhosis (as indicated in Appendix 1\). Liver biopsy should be scored using one of

•1\. Infection with any HCV genotype other than genotype 1 or an indeterminate or mixed genotype. Genotype 1 pts w indeterminate or mixed subtypes will be allowed
•2\. History of having received any IMP \= 3m prior to the 1st dose of study drug or the expectation that such drugs will be used during the study. Pts enrolled in this study cannot be enrolled in another study for either research, diagnostic or treatment purposes Pts who are expected to need systemic antiviral therapy with established or perceived activity against HCV at any time during their participation in the study are also excl
•4\. \+ test at screening for anti\-HAV IgM Ab, HBsAg, anti\-HBc IgM Ab, or anti\-HIV Ab
•5\. History or other evidence of a medical condition associated with chronic liver disease other than HCV
•6\. Females who are pregnant or breast feeding
•7\. Male partners of females who are pregnant
•8\. BMI \< 18 or \= 36
•9\. Absolute neutrophil count (ANC) \< 1\.5 x 103 / µL (\< 1\.5 x 109 /L)
•10\. Platelet count \< 90 x 103 / µL (\< 90 x 109 /L)
•11\. Hemoglobin (Hgb) concentration \< 11 g/dL (\< 110 g/L) in females or \< 12 g/dL (\<120 g/L)in males or any pt w a baseline increased risk for anemia or for whom anemia would be medically problematic