A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1

Roche

Status and phase: Completed; Phase 1

Conditions: Hepatitis C, Chronic

Treatments: Drug: danoprevir; Drug: ribavirin; Drug: placebo; Drug: peginterferon alfa-2a [Pegasys]; Drug: ritonavir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01185860

NP22660

2009-012426-36

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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59 participants in 3 patient groups, including a placebo group

A

Active Comparator group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: danoprevir

Drug: ribavirin

B

Experimental group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: ritonavir

Drug: danoprevir

Drug: ribavirin

C

Placebo Comparator group

Treatment:

Drug: peginterferon alfa-2a [Pegasys]

Drug: placebo

Drug: ritonavir

Drug: ribavirin