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

NCT00963885 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 229

Last updated 2016-11-02

No results posted yet for this study

Summary

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.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Copegus

1000 or 1200mg po daily for 24 or 48 weeks

DRUG

Pegasys

180micrograms sc weekly for 24 or 48 weeks

DRUG

Placebo

po for 12 weeks

DRUG

Placebo

po for 24 weeks

DRUG

RO5190591 (Danoprevir)

300mg po q8h for 12 weeks

DRUG

RO5190591 (Danoprevir)

600mg po q12h for 12 weeks

DRUG

RO5190591 (Danoprevir)

900mg po q12h for 12 weeks

DRUG

RO5190591 (Danoprevir)

300mg po q8h or 600mg po q12h or 900po q12h for 24 weeks

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2012-01-31
Completion
2012-01-31

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • France
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00963885 on ClinicalTrials.gov