Chronic Hepatitis C (CHC), Genotype 1 MedDRA version: 14.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Code: RO5024048/F14
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: RO5024048
Other descriptive name: HCV Polymerase Inhibitor Prodrug
Concentration unit: mg milligram(s)
Concent
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female aged 18 years and older - Serologic evidence of CHC infection by an anti-HCV antibody (Ab) test (current or historical) - Evidence of CHC infection > 6 months duration - Serum HCV RNA quantifiable at = 50,000 IU/mL as demonstrated by the Roche COBAS® TaqMan® HCV Test - Evidence of HCV genotype 1a or 1b infection by molecular assay - The following information related to the patient’s response to the previous course of PEG-IFN/RBV therapy must be available in the medical records of the patient: (1) approved doses of prior PEG-IFN/RBV treatment and the start/end date of previous treatment with PEG-IFN/RBV, (2) documentation of previous dose modifications or interruptions (or lack thereof) to ensure documentation of previous compliance with therapy, (3) HCV RNA prior to the start of previous treatment and at 12 weeks after the start of treatment (window of Week 11 to Week 16) showing a null response, defined as a =65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: - Positive test at screening for anti–hepatitis A virus (HAV) IgM Ab, hepatitis B surface antigen (HBsAg), or anti-HIV Ab - History of having received RO5024048/boceprevir or any cross-resistant DAA agent at any previous time or use of any other systemic antiviral therapy with established or perceived activity against HCV = 3 months prior to the first dose of study drug - 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. - History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, Wilson’s disease, alpha-1 antitrypsin deficiency, alcoholic liver disease, and/or toxin exposure) - Females who are pregnant or breastfeeding - Males with female partners who are pregnant - Absolute neutrophil count (ANC) 1.5 times the ULN - History of pre-existing renal disease. Patients with a history of nephrolithiasis will be allowed. - Estimated creatinine clearance (CRCL) of = 70 mL/min (= 1.17 mL/sec), calculated by the Cockcroft-Gault formula (see Appendix C) - Type 1 or 2 diabetes with glycosylated hemoglobin (HbA1c) of = 8.5% at the screening visit - History or other evidence of chronic pulmonary disease associated with functional limitation - History of severe cardiac disease (e.g., New York Heart Association Functional Class III or IV, myocardial infarction within 6 months, ventricular tachyarrhythmia requiring ongoing treatment, unstable angina, or other significant cardiovascular disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the sustained virologic response 12 weeks after treatment (SVR-12) for two experimental treatment groups (regimens containing RO5024048, boceprevir, Pegasys, and Copegus) in patients with previous null response to PEG-IFN/RBV combination therapy, defined as a < 2 log10 IU/mL decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV;Secondary Objective: - To estimate the sustained virologic response 24 weeks after treatment (SVR-24) for the two experimental treatment groups - To estimate the sustained virologic response 4 weeks after treatment (SVR-4) for the two experimental treatment groups - To estimate the virological response over time (all visits) for the experimental treatment groups - To estimate the proportion of patients who develop resistance to boceprevir and/or RO5024048 - To compare the safety and tolerability of the treatment groups;Primary end point(s): Sustained virologic response (SVR-12);Timepoint(s) of evaluation of this end point: 12 weeks after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To estimate SVR-4 between for the two experimental treatment groups - To estimate the virologic response over time (all visits) for the experimental treatment groups - To estimate the proportion of patients who develop resistance to boceprevir/or RO5024048 - To compare the safety and tolerability of the treatment groups;Timepoint(s) of evaluation of this end point: Baseline and all post-baseline visits. | — |
Countries
Canada, France, Germany, Italy, Spain, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd.
Outcome results
None listed