A Study of RO5190591 (Danoprevir) in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1 Virus Infection

Roche

Status and phase: Completed; Phase 2

Conditions: Hepatitis C, Chronic

Treatments: Drug: Placebo; Drug: RO5190591 (Danoprevir); Drug: Pegasys; Drug: Copegus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00963885

2009-009608-38

NV21075

Details and patient eligibility

About

This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.

Enrollment: 229 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients, >=18 years of age;
• chronic hepatitis C, genotype 1;
• treatment-naive.

Exclusion criteria

• liver cirrhosis and other forms of liver disease;
• HIV infection;
• hepatocellular cancer;
• cardiac disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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229 participants in 6 patient groups, including a placebo group

Part 1: Placebo

Placebo Comparator group

Description:

Placebo in combination with standard doses of Pegasys and Copegus.

Treatment:

Drug: Placebo

Drug: Pegasys

Drug: Placebo

Drug: Copegus

Part 1: RO5190591 300mg po

Experimental group

Description:

RO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus.

Treatment:

Drug: Pegasys

Drug: RO5190591 (Danoprevir)

Drug: Copegus

Drug: RO5190591 (Danoprevir)

Drug: RO5190591 (Danoprevir)

Drug: RO5190591 (Danoprevir)

Part 1: RO5190591 600mg po

Experimental group

Description:

RO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus.

Treatment:

Drug: Pegasys

Drug: RO5190591 (Danoprevir)

Drug: Copegus

Drug: RO5190591 (Danoprevir)

Drug: RO5190591 (Danoprevir)

Drug: RO5190591 (Danoprevir)

Part 1: RO5190591 900mg po

Experimental group

Description:

RO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.

Treatment:

Drug: Pegasys

Drug: RO5190591 (Danoprevir)

Drug: Copegus

Drug: RO5190591 (Danoprevir)

Drug: RO5190591 (Danoprevir)

Drug: RO5190591 (Danoprevir)

Part 2: Placebo

Placebo Comparator group

Description:

If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive placebo in combination with standard doses of Pegasys and Copegus.

Treatment:

Drug: Placebo

Drug: Pegasys

Drug: Placebo

Drug: Copegus

Part 2: RO5190591 300mg po

Experimental group

Description:

If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.

Treatment:

Drug: Pegasys

Drug: RO5190591 (Danoprevir)

Drug: Copegus

Drug: RO5190591 (Danoprevir)

Drug: RO5190591 (Danoprevir)

Drug: RO5190591 (Danoprevir)