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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

421

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

  • 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

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
Intervention / Treatment
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

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

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

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

November 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 7, 2010

First Submitted That Met QC Criteria

October 13, 2010

First Posted (Estimate)

October 14, 2010

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

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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