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

November 1, 2016 updated by: Hoffmann-La Roche

A Randomized, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

229

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New South Wales
      • Kingswood, New South Wales, Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
      • Wien, Austria, 1090
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
      • Edmonton, Alberta, Canada, T6G 2B7
      • Edmonton, Alberta, Canada, T5H 4B9
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver, British Columbia, Canada, V5Z 1H2
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
      • Toronto, Ontario, Canada, M5G 1L7
      • Clichy, France, 92118
      • Marseille, France, 13285
      • Montpellier, France, 34295
      • Paris, France, 75651
      • Frankfurt Am Main, Germany, 60590
      • Hamburg, Germany, 20099
    • Campania
      • Napoli, Campania, Italy, 80131
    • Arizona
      • Phoenix, Arizona, United States, 85054
    • California
      • Long Beach, California, United States, 90822
      • Los Angeles, California, United States, 90045
      • Sacramento, California, United States, 95817
      • San Diego, California, United States, 92123
      • San Diego, California, United States, 92154
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Gainesville, Florida, United States, 32610-0214
      • Jacksonville, Florida, United States, 32256
      • Orlando, Florida, United States, 32809
    • Illinois
      • Lombard, Illinois, United States, 60148
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
      • Detroit, Michigan, United States, 48202-2689
    • New York
      • Manhasset, New York, United States, 11030
      • New York, New York, United States, 10029-6574
    • North Carolina
      • Asheville, North Carolina, United States, 28801
      • Chapel Hill, North Carolina, United States, 27599-7584
    • Oregon
      • Medford, Oregon, United States, 97504
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604-3200
    • Texas
      • San Antonio, Texas, United States, 78215
    • Utah
      • Salt Lake City, Utah, United States, 84132
    • Washington
      • Vancouver, Washington, United States, 98664
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Part 1: Placebo
Placebo in combination with standard doses of Pegasys and Copegus.
1000 or 1200mg po daily for 24 or 48 weeks
180micrograms sc weekly for 24 or 48 weeks
po for 12 weeks
po for 24 weeks
Experimental: Part 1: RO5190591 300mg po
RO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus.
1000 or 1200mg po daily for 24 or 48 weeks
180micrograms sc weekly for 24 or 48 weeks
300mg po q8h for 12 weeks
600mg po q12h for 12 weeks
900mg po q12h for 12 weeks
300mg po q8h or 600mg po q12h or 900po q12h for 24 weeks
Experimental: Part 1: RO5190591 600mg po
RO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
1000 or 1200mg po daily for 24 or 48 weeks
180micrograms sc weekly for 24 or 48 weeks
300mg po q8h for 12 weeks
600mg po q12h for 12 weeks
900mg po q12h for 12 weeks
300mg po q8h or 600mg po q12h or 900po q12h for 24 weeks
Experimental: Part 1: RO5190591 900mg po
RO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
1000 or 1200mg po daily for 24 or 48 weeks
180micrograms sc weekly for 24 or 48 weeks
300mg po q8h for 12 weeks
600mg po q12h for 12 weeks
900mg po q12h for 12 weeks
300mg po q8h or 600mg po q12h or 900po q12h for 24 weeks
Placebo Comparator: Part 2: Placebo
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.
1000 or 1200mg po daily for 24 or 48 weeks
180micrograms sc weekly for 24 or 48 weeks
po for 12 weeks
po for 24 weeks
Experimental: Part 2: RO5190591 300mg po
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.
1000 or 1200mg po daily for 24 or 48 weeks
180micrograms sc weekly for 24 or 48 weeks
300mg po q8h for 12 weeks
600mg po q12h for 12 weeks
900mg po q12h for 12 weeks
300mg po q8h or 600mg po q12h or 900po q12h for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained virological response
Time Frame: 24 weeks after end of treatment
24 weeks after end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Virological response over time
Time Frame: At 2- to 6-weekly intervals throughout study; at end of treatment; 12 weeks post-treatment
At 2- to 6-weekly intervals throughout study; at end of treatment; 12 weeks post-treatment
Adverse events; laboratory parameters
Time Frame: Throughout study, laboratory parameters every 2 to 6 weeks
Throughout study, laboratory parameters every 2 to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

August 18, 2009

First Submitted That Met QC Criteria

August 21, 2009

First Posted (Estimate)

August 24, 2009

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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