A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection.

November 1, 2016 updated by: Hoffmann-La Roche

A Randomized, Double-blinded Study to Evaluate the Safety and Effect on Sustained Virological Response of HCV Polymerase Inhibitor Pro-drug in Combination With PEGASYS Plus Copegus, Compared With the Currently Approved Combination of PEGASYS Plus Copegus, in Treatment-naïve Patients With Chronic he

This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or 180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks. Group 7 will receive standard of care (SOC) for 48 weeks. There will be a 24 week period of treatment-free follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months, 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.
516

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
      • Adelaide, Australia, 5000
      • Greenslopes, Australia, 4120
      • Melbourne, Australia, 3004
      • Sydney, Australia, 2050
      • Sydney, Australia, 2145
  • Austria
      • Wien, Austria, 1090
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver, British Columbia, Canada, V5Z 1H2
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
      • Toronto, Ontario, Canada, M5G 1L7
  • France
      • Clichy, France, 92118
      • Creteil, France, 94010
      • Marseille, France, 13285
      • Paris, France, 75014
      • Paris, France, 75651
      • Pessac, France, 33604
      • Vandoeuvre-les-nancy, France, 54511
  • Germany
      • Berlin, Germany, 13353
      • Frankfurt Am Main, Germany, 60590
      • Freiburg, Germany, 79106
      • Hamburg, Germany, 20246
      • Hannover, Germany, 30625
      • Köln, Germany, 50937
  • Italy
      • Bologna, Italy, 40138
      • Napoli, Italy, 80131
      • Torino, Italy, 10126
  • Puerto Rico
      • Santurce, Puerto Rico, 00909
  • Spain
      • Badalona, Spain, 08915
      • Barcelona, Spain, 08003
      • Madrid, Spain, 28222
      • Sevilla, Spain, 41014
      • Valencia, Spain, 46014
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
    • California
      • La Jolla, California, United States, 92037-1030
      • Long Beach, California, United States, 90822
      • Sacramento, California, United States, 95817
      • San Diego, California, United States, 92103-8465
      • San Diego, California, United States, 92154
      • San Francisco, California, United States, 94115
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Englewood, Colorado, United States, 80110
    • Florida
      • Bradenton, Florida, United States, 34209
      • Gainesville, Florida, United States, 32610-0214
      • Miami, Florida, United States, 33136-1051
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Maryland
      • Baltimore, Maryland, United States, 21287
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
    • New York
      • Bronx, New York, United States, 10468
      • Manhasset, New York, United States, 11030
      • New York, New York, United States, 10021
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7584
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0595
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
    • Tennessee
      • Nashville, Tennessee, United States, 37211
    • Texas
      • Dallas, Texas, United States, 75203
      • Fort Sam Houston, Texas, United States, 78234-3879
      • San Antonio, Texas, United States, 78215
    • Utah
      • Salt Lake City, Utah, United States, 84121
    • Virginia
      • Fairfax, Virginia, United States, 22031
      • Richmond, Virginia, United States, 23249

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients, 18-65 years of age;
  • chronic hepatitis C, genotype 1;
  • chronic liver disease consistent with CHC;
  • compensated liver disease.

Exclusion Criteria:

  • infection with any HCV genotype other than genotype 1;
  • previous treatment for CHC;
  • medical condition associated with chronic liver disease other than CHC;
  • HIV, hepatitis A, hepatitis B infection.

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.
Experimental: Group 1
Group 1 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1000 po bid) plus PEGASYS (180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).
Drug: Copegus
1000/1200mg po daily for 24 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 weeks
Drug: Pegasys
90 micrograms sc weekly for 24 weeks
Drug: RO4588161
1000mg po bid for 24 weeks
Drug: RO4588161
500mg po bid for 24 weeks
Drug: RO4588161
1500mg po bid for 24 weeks
Experimental: Group 2
Group 2 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (500 mg po bid) plus PEGASYS (180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).
Drug: Copegus
1000/1200mg po daily for 24 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 weeks
Drug: Pegasys
90 micrograms sc weekly for 24 weeks
Drug: RO4588161
1000mg po bid for 24 weeks
Drug: RO4588161
500mg po bid for 24 weeks
Drug: RO4588161
1500mg po bid for 24 weeks
Experimental: Group 3
Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks.
Drug: Copegus
1000/1200mg po daily for 24 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 weeks
Drug: Pegasys
90 micrograms sc weekly for 24 weeks
Drug: RO4588161
1000mg po bid for 24 weeks
Drug: RO4588161
500mg po bid for 24 weeks
Drug: RO4588161
1500mg po bid for 24 weeks
Experimental: Group 4
Group 4 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1500 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).
Drug: Copegus
1000/1200mg po daily for 24 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 weeks
Drug: Pegasys
90 micrograms sc weekly for 24 weeks
Drug: RO4588161
1000mg po bid for 24 weeks
Drug: RO4588161
500mg po bid for 24 weeks
Drug: RO4588161
1500mg po bid for 24 weeks
Experimental: Group 5
Group 5 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (1000 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).
Drug: Copegus
1000/1200mg po daily for 24 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 weeks
Drug: Pegasys
90 micrograms sc weekly for 24 weeks
Drug: RO4588161
1000mg po bid for 24 weeks
Drug: RO4588161
500mg po bid for 24 weeks
Drug: RO4588161
1500mg po bid for 24 weeks
Experimental: Group 6
Group 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (500 mg po bid) plus PEGASYS (90 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd).
Drug: Copegus
1000/1200mg po daily for 24 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 weeks
Drug: Pegasys
90 micrograms sc weekly for 24 weeks
Drug: RO4588161
1000mg po bid for 24 weeks
Drug: RO4588161
500mg po bid for 24 weeks
Drug: RO4588161
1500mg po bid for 24 weeks
Active Comparator: Group 7
Standard of care (SOC)
Drug: Copegus
1000/1200mg po daily for 24 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 weeks
Drug: Pegasys
90 micrograms sc weekly 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 (SVR)
Time Frame: 24 weeks post treatment end (ie weeks 48 or 72)
24 weeks post treatment end (ie weeks 48 or 72)

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: Throughout study
Throughout study
SVR
Time Frame: 12 weeks post treatment end (ie weeks 36 or 60)
12 weeks post treatment end (ie weeks 36 or 60)
Relapse rate
Time Frame: End of treatment (ie weeks 24 or 48)
End of treatment (ie weeks 24 or 48)
Adverse events (AEs), laboratory parameters.
Time Frame: Throughout treatment
Throughout treatment

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.
December 1, 2007

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, 2010

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, 2010

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 16, 2007

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 16, 2007

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 17, 2007

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.
  • NV19865

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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