Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
Danoprevir/ritonavir with peginterferon alfa-2a plus ribavirin in cirrhotic chronic hepatitis C genotype 1 or 4 patients
2011-004129-28Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2011
- Countries
- 1
- Sponsor
- Roche
- Modality
- Small Molecules, Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules, DNA Intercalators/Alkylators → Nucleic Acid-Directed Small Molecules → Small Molecules
- Conditions
- hepatitis C virus infection
01
Overview
Phase 2, open-label trial of danoprevir, ritonavir, mericitabine, peginterferon alfa-2a and ribavirin in hepatitis C virus infection (2 cohorts), sponsored by Roche. Primary endpoints: Safety, Tolerability and 2 more. Started Dec 2011; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Treatment-naive cohort
Treatment-naive chronic hepatitis C genotype 1 or 4 patients with compensated cirrhosis treated with danoprevir/ritonavir plus peginterferon alfa-2a and ribavirin.
Previous null responder cohort
Previous null responder chronic hepatitis C genotype 1 or 4 patients with compensated cirrhosis treated with danoprevir/ritonavir and RO5024048 plus peginterferon alfa-2a and ribavirin.
03
Who it enrols
Adults with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis were eligible. One cohort enrolled treatment-naive patients and another enrolled prior null responders. Patients with any history or presence of decompensated liver disease, including ascites, hepatic encephalopathy, hepatocellular carcinoma, or bleeding esophageal varices, were excluded.
04
Endpoints
Primary
Safety
Tolerability
Pharmacokinetics
Antiviral activity
Secondary
Resistance emergence
Beyond the preview
Go deeper on 2011-004129-28.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on 2011-004129-28.