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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
229

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Australia
    • New South Wales
      • Kingswood, New South Wales, Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
  • Austria
      • Wien, Austria, 1090
  • Canada
    • 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
  • France
      • Clichy, France, 92118
      • Marseille, France, 13285
      • Montpellier, France, 34295
      • Paris, France, 75651
  • Germany
      • Frankfurt Am Main, Germany, 60590
      • Hamburg, Germany, 20099
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Part 1: Placebo
Placebo in combination with standard doses of Pegasys and Copegus.
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
Experimental: Part 1: RO5190591 300mg po
RO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus.
Drug: Copegus
1000 or 1200mg po daily for 24 or 48 weeks
Drug: Pegasys
180micrograms sc weekly for 24 or 48 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
Experimental: Part 1: RO5190591 600mg po
RO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
Drug: Copegus
1000 or 1200mg po daily for 24 or 48 weeks
Drug: Pegasys
180micrograms sc weekly for 24 or 48 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
Experimental: Part 1: RO5190591 900mg po
RO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
Drug: Copegus
1000 or 1200mg po daily for 24 or 48 weeks
Drug: Pegasys
180micrograms sc weekly for 24 or 48 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
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.
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
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.
Drug: Copegus
1000 or 1200mg po daily for 24 or 48 weeks
Drug: Pegasys
180micrograms sc weekly for 24 or 48 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Sustained virological response
Time Frame: 24 weeks after end of treatment
24 weeks after end of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NV21075
  • 2009-009608-38

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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