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

F.Hoffmann-La Roche0 sites300 target enrollmentSeptember 7, 2009

ConditionsChronic Hepatitis C (CHC) Genotype 1 MedDRA version: 12.0Level: LLTClassification code 10008912Term: Chronic hepatitis C

DrugsPegasys

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chronic Hepatitis C (CHC) Genotype 1
Sponsor: F.Hoffmann-La Roche
Enrollment: 300
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 7, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

F.Hoffmann-La Roche

Eligibility Criteria

Inclusion Criteria

•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 \&\#8805; 50,000 IU/mL as demonstrated by the Roche COBAS TaqMan HCV Test;
•6\. HCV treatment\-na?ve (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
•the scoring methods in Appendix 1;
•8\. Normal cardiac troponin I (cTnI) value at the screening visit (\< 0\.100 ng/mL);

Exclusion Criteria

•1\. Infection with any HCV genotype other than genotype 1 or an indeterminate or mixed genotype. Genotype 1 patients with indeterminate or mixed subtypes will be allowed
•(for example, genotype 1a/b);
•2\. History of having received any investigational drug \&\#8804; 3 months prior to the first dose of study drug or the expectation that such drugs will be used during the study. Patients enrolled in this study cannot be enrolled in another study for either research, diagnostic or treatment purposes; 3\. Patients 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 excluded; 4\. Positive 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 (e.g., hemochromatosis, autoimmune hepatitis, Wilsons disease,
•\&\#945;1\-antitrypsin deficiency, metabolic liver disease, alcoholic liver disease, and/or toxin exposure);
•6\. Females who are pregnant or breast feeding; 7\. Male partners of females who are pregnant; 8\. Body mass index (BMI) \< 18 or \&\#8805; 36; 9\. Absolute neutrophil count (ANC) \< 1\.5 x 103 / \&\#956;L (\< 1\.5 x 109 /L); 10\. Platelet count \< 90 x 103 / \&\#956;L (\< 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 patient with a baseline increased risk for anemia (e.g., thalassemia, sickle cell anemia, spherocytosis, history of gastrointestinal bleeding) or
•for whom anemia would be medically problematic; 12\. Serum creatinine level \> 1\.5 times the upper limit of normal at screening; 13\. The use of colony stimulating factors such as granulocyte colony stimulating factor
•(G\-CSF), erythropoietin, blood transfusion or other therapeutic agents to elevate hematology parameters to facilitate patient entry into the study within the last