A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1
Phase 1
Completed
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT01185860
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A peginterferon alfa-2a [Pegasys] - A ribavirin - B danoprevir - B peginterferon alfa-2a [Pegasys] - C peginterferon alfa-2a [Pegasys] - C placebo - A danoprevir - B ribavirin - B ritonavir - C ribavirin - C ritonavir -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Viral resistance development from baseline to Day 17 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 Comparison of pharmacokinetics and antiviral activity between treatment-naïve patients and prior null-responders to standard of care treatment approximately 3 years