A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection

November 1, 2016 updated by: Hoffmann-La Roche
This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.

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.
421

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

  • Austria
      • Wien, Austria, 1090
  • Brazil
    • BA
      • Salvador, BA, Brazil, 40210-341
    • RS
      • Porto Alegre, RS, Brazil, 90035-003
    • SP
      • Ribeirao Preto, SP, Brazil, 14049-900
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2S2
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver, British Columbia, Canada, V6Z 2K5
      • Victoria, British Columbia, Canada, V8V 3P9
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
      • Toronto, Ontario, Canada, M5G 1L7
  • France
      • Clichy, France, 92118
      • Creteil, France, 94010
      • Marseille, France, 13285
      • Paris, France, 75679
      • Rennes, France, 35033
      • Toulouse, France, 31059
      • Vandoeuvre-les-nancy, France, 54511
  • Germany
      • Berlin, Germany, 10969
      • Frankfurt Am Main, Germany, 60590
      • Freiburg, Germany, 79106
      • Hamburg, Germany, 20099
      • Leipzig, Germany, 04103
      • Wuerzburg, Germany, 97080
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
    • Lombardia
      • Milano, Lombardia, Italy, 20121
      • Pavia, Lombardia, Italy, 27100
    • Piemonte
      • Novara, Piemonte, Italy, 28100
    • Puglia
      • Bari, Puglia, Italy, 70124
  • Mexico
      • Guadalajara, Mexico, 44650
      • Monterrey, Mexico, 64710
  • Puerto Rico
      • Santurce, Puerto Rico, 00909
  • Spain
      • Barcelona, Spain, 08003
      • Madrid, Spain, 28034
      • Madrid, Spain, 28222
      • Sevilla, Spain, 41014
    • Barcelona
      • Badalona, Barcelona, Spain, 08915
  • United Kingdom
      • London, United Kingdom, SE5 9RS
      • London, United Kingdom, E1 1BB
      • London, United Kingdom, SW17 0QT
      • London, United Kingdom, W1 1TF
      • Nottingham, United Kingdom, NG7 2UH
  • United States
    • California
      • La Jolla, California, United States, 92037-1030
      • Sacramento, California, United States, 95817
      • San Diego, California, United States, 92154
      • San Francisco, California, United States, 94143
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Orlando, Florida, United States, 32809
      • Orlando, Florida, United States, 32804
      • South Miami, Florida, United States, 33143
    • Georgia
      • Decatur, Georgia, United States, 30033
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Maryland
      • Lutherville, Maryland, United States, 21093
    • Michigan
      • Detroit, Michigan, United States, 48202-2689
    • 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
      • Fayetteville, North Carolina, United States, 28304
    • Oregon
      • Medford, Oregon, United States, 97504
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
    • Tennessee
      • Nashville, Tennessee, United States, 37211
    • Texas
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78215
      • San Antonio, Texas, United States, 78234
    • Virginia
      • Newport News, Virginia, United States, 23602

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:

  • Adults patients, >/=18 years of age
  • Chronic Hepatitis C, Genotype 1 and 4
  • HCV RNA >/=50,000 IU/mL
  • treatment-naive

Exclusion Criteria:

  • Patients with cirrhosis or incomplete/transition to cirrhosis
  • Patients with other forms of liver disease, HIV infection, hepatocellular carcinoma or severe 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: None (Open Label)

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 A
Danoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Drug: Ritonavir
Ritonavir 100 mg
Drug: Copegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Drug: Danoprevir
Danoprevir 50 mg BID
Drug: Danoprevir
Danoprevir 100 mg BID
Drug: Danoprevir
Danoprevir 200 mg BID
Drug: Pegasys
Pegasys 180 microgram sc qw
Experimental: Group B
Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Drug: Ritonavir
Ritonavir 100 mg
Drug: Copegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Drug: Danoprevir
Danoprevir 50 mg BID
Drug: Danoprevir
Danoprevir 100 mg BID
Drug: Danoprevir
Danoprevir 200 mg BID
Drug: Pegasys
Pegasys 180 microgram sc qw
Experimental: Group C
Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Drug: Ritonavir
Ritonavir 100 mg
Drug: Copegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Drug: Danoprevir
Danoprevir 50 mg BID
Drug: Danoprevir
Danoprevir 100 mg BID
Drug: Danoprevir
Danoprevir 200 mg BID
Drug: Pegasys
Pegasys 180 microgram sc qw
Experimental: Group D
Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks
Drug: Ritonavir
Ritonavir 100 mg
Drug: Copegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Drug: Danoprevir
Danoprevir 50 mg BID
Drug: Danoprevir
Danoprevir 100 mg BID
Drug: Danoprevir
Danoprevir 200 mg BID
Drug: Pegasys
Pegasys 180 microgram sc qw
Active Comparator: Group E
Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 48 weeks
Drug: Copegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Drug: Pegasys
Pegasys 180 microgram sc qw

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 (HCV RNA measured by Roche COBAS TaqMan HCV test)
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
Safety: Incidence of adverse events
Time Frame: from baseline up to 72 weeks
from baseline up to 72 weeks
Evaluation of relapse rate
Time Frame: up to 24 weeks after end of treatment
up to 24 weeks after end of treatment
Characterization of resistance profile (HCV RNA sequencing and/or phenotypic analyses)
Time Frame: from baseline up to 72 weeks
from baseline up to 72 weeks
Virological response at scheduled visits over time (HCV RNA measured by Roche COBAS TaqMan HCV test)
Time Frame: From baseline up to 72 weeks
From baseline up to 72 weeks
Evaluation of virological breakthrough (viral load rebound) rate
Time Frame: up to 72 weeks
up to 72 weeks
Evaluation of pharmacokinetics (serum concentrations assessed by validated methods)
Time Frame: up to 72 weeks
up to 72 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

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.
November 1, 2010

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.
December 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.
December 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).
October 7, 2010

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.
October 13, 2010

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.
October 14, 2010

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.
  • NV22776
  • 2010-019584-10

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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