A Phase II, Randomized, Double-Blinded, Multicenter, Dose Finding Study Evaluating the Efficacy and Safety of the HCV Polymerase Inhibitor Prodrug (RO4588161) when given in combination with Pegasys® and Copegus® versus the currently approved combination of Pegasys® and Copegus® in Treatment-Naive Patients with Chronic Hepatitis C Genotype 1 Virus infectio
- Conditions
- Chronic hepatitis CMedDRA version: 9.1Level: LLTClassification code 10008912Term: Chronic hepatitis C
- Registration Number
- EUCTR2006-006604-11-FR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 490
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 scoring methods in Appendix 2 of the protocol
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
1) Infection with any HCV genotype other than genotype 1 or an indeterminate or mixed genotype
2) History of having received any IFN, PEG-IFN, RBV, viramidine, levovirin, or investigational HCV polymerase or protease inhibitors at any previous time
3) History of having received any investigational drug less than or equal to 3 months prior to the first dose of study
4) Patients who are expected to need systemic antiviral therapy with established or perceived activity against HCV
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
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 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
16) History of immunologically mediated disease
17) History or other evidence of decompensated liver disease or a Child-Pugh score >6
18) History or other evidence of chronic pulmonary disease associated with functional limitation
19) History of severe cardiac disease. In addition, patients with documented or presumed coronary artery disease, stable or unstable cardiovascular disease or cerebrovascular disease should not be enrolled as an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin or RO4588161 therapy) may occur.
20) Patients with higher potential for QTC prolongation; patients with any clinical condition that increases the risk of QTC prolongation; personal or family history of congenital long QT syndrome or sudden death, which would make the patient, in the opinion of the investigator, unsuitable for the study
21) History of uncontrolled severe seizure disorder
22) Evidence of an active or suspected cancer, or a history of malignancy where the risk of recurrence is = 20% within 2 years
23) History of any systemic anti-neoplastic or immunomodulatory treatment
24) Poorly controlled thyroid dysfunction
25) History or other evidence of a clinically relevant ophthalmologic disorder due to diabetes mellitus or hypertension or history or other evidence of severe retinopathy
26) History of major organ transplantation with an existing functional graft
27) History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
28) Evidence of excessive alcohol, drug or substance abuse within 1 year of first dose
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method