A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C

November 1, 2016 updated by: Hoffmann-La Roche

A Randomized Open-label Study to Evaluate the Sustained Virologic Response of Danoprevir/Ritonavir and Copegus in Combination With RO5024048 and/or Pegasys in Chronic Hepatitis C Genotype 1 Patients Who Failed Previous Standard Therapy

This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.

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.
381

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
      • Darlinghurst, New South Wales, Australia, 2010
      • Kingswood, New South Wales, Australia, 2747
      • Westmead, New South Wales, Australia, 2145
    • South Australia
      • Adelaide, South Australia, Australia, 5000
    • Victoria
      • Melbourne, Victoria, Australia, 3004
      • Melbourne, Victoria, Australia, 3186
  • Austria
      • Wien, Austria, 1090
  • Brazil
    • RS
      • Porto Alegre, RS, Brazil, 90035-003
    • SP
      • Ribeirao Preto, SP, Brazil, 14049-900
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
      • Edmonton, Alberta, Canada, T6G 2B7
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver, British Columbia, Canada, V5Z 1H2
      • Vancouver, British Columbia, Canada, V6Z 2K5
    • Ontario
      • London, Ontario, Canada, N6A 5A5
      • Ottawa, Ontario, Canada, K1H 8L6
      • Toronto, Ontario, Canada, M5G 1L7
  • France
      • La Tronche, France, 38700
      • Paris, France, 75651
      • Paris, France, 75679
      • Pessac, France, 33604
      • Vandoeuvre-les-nancy, France, 54511
  • Germany
      • Berlin, Germany, 13353
      • Essen, Germany, 45122
      • Kiel, Germany, 24105
      • Tübingen, Germany, 72076
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80135
    • Lombardia
      • Milano, Lombardia, Italy, 20162
      • Pavia, Lombardia, Italy, 27100
    • Toscana
      • Pisa, Toscana, Italy, 56124
  • Mexico
      • Guadalajara, Mexico, 44650
      • Guadalajara, Mexico, 44280
  • Poland
      • Bydgoszcz, Poland, 85-030
      • Czeladz, Poland, 41-250
      • Kielce, Poland, 25-317
      • Warszawa, Poland, 01-201
      • Łodz, Poland, 91-347
  • Puerto Rico
      • San Juan, Puerto Rico, 00927
  • Spain
      • Barcelona, Spain, 08003
      • Madrid, Spain, 28034
      • Madrid, Spain, 28222
      • Sevilla, Spain, 41014
    • Barcelona
      • Badalona, Barcelona, Spain, 08915
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
      • Dundee, United Kingdom, DD1 9SY
      • London, United Kingdom, E1 1BB
      • London, United Kingdom, W2 1PG
      • Manchester, United Kingdom, M8 5RB
  • United States
    • 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
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Orlando, Florida, United States, 32804
    • Georgia
      • Decatur, Georgia, United States, 30033
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Michigan
      • Detroit, Michigan, United States, 48202-2689
    • New York
      • Manhasset, New York, United States, 11030
      • New York, New York, United States, 10021
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7584
    • 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

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, age 18 years and older
  • Presence of hepatitis C infection, genotype 1a or 1b
  • Documentation of previous treatment failure after receiving approved doses of peginterferon plus ribavirin for at least 12 weeks
  • Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to study start

Exclusion Criteria:

  • Infection with any hepatitis C genotype or subtype other than genotype 1a or 1b
  • Patients with cirrhosis
  • Patients who were discontinued from previous peginterferon plus ribavirin therapy due to reasons other than insufficient therapeutic response
  • Co-infection with hepatitis B or human immunodeficiency virus (HIV)
  • History or evidence of chronic liver disease other than hepatitis C

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: Previous null responders (Cohort B): Group 4
Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
Drug: Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
Drug: Copegus
1000 mg or 1200 mg daily oral doses for 48 weeks
Drug: RO5024048
1000 mg oral doses twice a day for 24 weeks
Drug: danoprevir
100 mg oral doses twice a day for 24 weeks
Drug: ritonavir
100 mg oral doses twice a day for 24 weeks
Experimental: Previous null responders (Cohort B): Group 5
Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 5 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
Drug: Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
Drug: Copegus
1000 mg or 1200 mg daily oral doses for 48 weeks
Drug: RO5024048
1000 mg oral doses twice a day for 24 weeks
Drug: danoprevir
100 mg oral doses twice a day for 24 weeks
Drug: ritonavir
100 mg oral doses twice a day for 24 weeks
Drug: Pegasys
180 microgram subcutaneously once weekly for 24 weeks
Drug: Pegasys
180 microgram subcutaneously once weekly for 48 weeks
Experimental: Previous null responders (Cohort B): Group 6
Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.
Drug: Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
Drug: Copegus
1000 mg or 1200 mg daily oral doses for 48 weeks
Drug: RO5024048
1000 mg oral doses twice a day for 24 weeks
Drug: danoprevir
100 mg oral doses twice a day for 24 weeks
Drug: ritonavir
100 mg oral doses twice a day for 24 weeks
Drug: Pegasys
180 microgram subcutaneously once weekly for 24 weeks
Drug: Pegasys
180 microgram subcutaneously once weekly for 48 weeks
Experimental: Previous partial responders (Cohort A): Group 1
Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 1 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
Drug: Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
Drug: Copegus
1000 mg or 1200 mg daily oral doses for 48 weeks
Drug: RO5024048
1000 mg oral doses twice a day for 24 weeks
Drug: danoprevir
100 mg oral doses twice a day for 24 weeks
Drug: ritonavir
100 mg oral doses twice a day for 24 weeks
Experimental: Previous partial responders (Cohort A): Group 2
Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
Drug: Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
Drug: Copegus
1000 mg or 1200 mg daily oral doses for 48 weeks
Drug: danoprevir
100 mg oral doses twice a day for 24 weeks
Drug: ritonavir
100 mg oral doses twice a day for 24 weeks
Drug: Pegasys
180 microgram subcutaneously once weekly for 24 weeks
Drug: Pegasys
180 microgram subcutaneously once weekly for 48 weeks
Experimental: Previous partial responders (Cohort A): Group 3
Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 3 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
Drug: Copegus
1000 mg or 1200 mg daily oral doses for 24 weeks
Drug: Copegus
1000 mg or 1200 mg daily oral doses for 48 weeks
Drug: RO5024048
1000 mg oral doses twice a day for 24 weeks
Drug: danoprevir
100 mg oral doses twice a day for 24 weeks
Drug: ritonavir
100 mg oral doses twice a day for 24 weeks
Drug: Pegasys
180 microgram subcutaneously once weekly for 24 weeks
Drug: Pegasys
180 microgram subcutaneously once weekly for 48 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) of danoprevir/ritonavir with RO5024048 and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment
Time Frame: 24 weeks
24 weeks
Sustained virological response (SVR) of danoprevir/ritonavir with Pegasys and Copegus in patients with previous partial response to peginterferon/ribavirin treatment
Time Frame: 24 weeks
24 weeks
Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment
Time Frame: 24 weeks
24 weeks
Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus followed by 24 weeks of Pegasys and Copegus treatment in patients with previous null response to peginterferon/ribavirin treatment
Time Frame: 48 weeks
48 weeks

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) of danoprevir, RO5024048 and Copegus
Time Frame: 48 weeks
48 weeks
Safety (Incidence of adverse events) of danoprevir, Pegasys and Copegus
Time Frame: 48 weeks
48 weeks
Safety (Incidence of adverse events) of danoprevir, RO5024048, Pegasys and Copegus
Time Frame: 72 weeks
72 weeks
Virological response over time
Time Frame: 48 weeks
48 weeks
Change in danoprevir plasma concentration
Time Frame: 24 weeks
24 weeks
Change in RO5024048 plasma concentration
Time Frame: 24 weeks
24 weeks
Hepatitis C virus drug resistance profile
Time Frame: 24 weeks
24 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.
May 1, 2011

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, 2013

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, 2013

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).
March 28, 2011

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.
April 7, 2011

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.
April 8, 2011

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.
  • WV21913
  • 2010-019585-90

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.

Clinical Trials on Hepatitis C, Chronic

Clinical Trials on Copegus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings