A Phase II, Randomized, Double-Blinded, Multicenter, Dose Finding Study Evaluating the Efficacy and Safety of the HCV Polymerase Inhibitor Prodrug (RO4588161) When Given inCombination with Pegasys and Copegus versus the Currently Approved Combination of Pegasys and Copegus inTreatment-Naive Patients with Chronic Hepatitis C Genotype 1 Virus Infection. - ND

• Conditions: Chronic Hepatitis C (CHC).; MedDRA version: 9.1Level: LLTClassification code 10019744Term: Hepatitis C

• Registration Number: EUCTR2006-006604-11-IT
• Lead Sponsor: ROCHE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

1. Age 18 ? 65 years

2. Serologic evidence of CHC infection by an anti-HCV antibody test (current or historical)

3. Evidence of hepatitis C genotype 1 infection by molecular assay

4. Serum HCV RNA quantifiable at > 10,000 IU/mL as demonstrated by the Roche COBAS TaqMan HCV Test

5. Chronic liver disease consistent with chronic hepatitis C infection on a biopsy obtained within the past 24 months (36 months for patients with cirrhosis or incomplete/transition to cirrhosis), using one of the proposed scoring methods.

6. Patients with cirrhosis or incomplete/transition to cirrhosis must have an abdominal ultrasound, computerized tomographic (CT) scan, or magnetic resonance imaging (MRI) scan without evidence of hepatocellular carcinoma (within 2 months prior to randomization) and a serum alpha-fetoprotein (AFP) < 100 ng/mL

7. Compensated liver disease (Child-Pugh Grade A clinical classification only)

8. Negative serum pregnancy test (for females of childbearing potential)

documented within the 24-hour period prior to the first dose of study drugs.Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during treatment and for 6 months after treatment end

9. Willingness to give written informed consent and willingness to participate in and comply with the study requirements
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

2. History of having received any IFN, PEG-IFN, RBV, viramidine, levovirin, or

investigational HCV polymerase or protease inhibitors at any previous time, or any other systemic antiviral therapy with established or perceived activity against the hepatitis C virus < 3 months prior to the first dose of study drug

3. History of having received any investigational drug < 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

4. 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

5. Positive test at screening for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab, or

anti-HIV Ab

6. History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)

7. Females who are pregnant or breast feeding

8. Male partners of females who are pregnant

9. Body mass index (BMI) > 36 or < 18

10. Absolute neutrophil count (ANC) < 2000 cells/mm3

11. Platelet count <90,000 cells/mm3

12. Hemoglobin concentration < 12 g/dL in females or <13 g/dL 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

13. Serum creatinine level > 1.5 times the upper limit of normal at screening

14. The use of colony stimulating factors such as granulocyte colony stimulating factor (G-CSF), erythropoietin or other therapeutic agents to elevate hematology

parameters to facilitate patient entry into the study

15. History of severe psychiatric disease, including psychosis and/or depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a

period of disability as a result of psychiatric disease

16. History of immunologically mediated disease (e.g., inflammatory bowel disease,

idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune

hemolytic anemia, scleroderma, severe psoriasis (defined as affecting > 10% of

the body, where the palm of one hand equals 1%, or if the hands and feet are affected), rheumatoid arthritis requiring more than intermittent nonsteroidal antiinflammatory

medications for management)

17. History or other evidence of decompensated liver disease or a Child-Pugh score >6. Coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, and bleeding from esophageal varices are conditions consistent with decompensated liver disease

18. History or other evidence of chronic pulmonary disease associated with functional limitation; Etc...

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified