Hepatitis C, Chronic
Conditions
Brief summary
This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.
Interventions
DRUGdanoprevir
oral doses
DRUGpeginterferon alfa-2a [Pegasys]
180 mcg sc once weekly
DRUGplacebo
oral doses
DRUGribavirin
1000-1200mg/day po
DRUGritonavir
oral doses
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults, 18-65 years of age * Chronic hepatitis C genotype 1 * HCV treatment naïve, or without sustained virologic response on prior PEG-INF/RBV treatment * Body mass index (BMI) 18 - 35 kg/m2, inclusive; minimum weight 45 kg
Exclusion criteria
* Liver cirrhosis * Decompensated liver disease or impaired liver function * Medical condition associated with chronic liver disease other than chronic hepatitis C * Positive for hepatitis B or HIV infection at screening * History of alcohol consumption exceeding 2 standard drinks per day when averaged over the course of a given week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability: Adverse events, ECG, laboratory parameters | approximately 3 years |
| Pharmacokinetics: Cmax, AUC, Cmin, Tmax, Cl, T1/2 | Days 3-9 |
| Antiviral activity: HCV RNA (COBAS Taqman HCV Test) | from baseline to Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Viral resistance development | from baseline to Day 17 |
| Comparison of pharmacokinetics and antiviral activity between treatment-naïve patients and prior null-responders to standard of care treatment | approximately 3 years |
| Effects on cytochrome P450(CYP)2C9 and 3A isozymes | from baseline to Day 17 |
| Virological response in prior null-responders | from baseline to week 72 |
Countries
France, New Zealand, Poland
Outcome results
None listed