A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4

November 1, 2016 updated by: Hoffmann-La Roche

A Randomized, Double-blinded, Multicenter Study to Evaluate the Antiviral Efficacy and Safety of Adding the HCV Polymerase Inhibitor Prodrug (RO5024048) for 24 Weeks to the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 or 4

This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is <200.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

168

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1H2
      • Vancouver, British Columbia, Canada, V6Z 2K5
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
    • Ontario
      • London, Ontario, Canada, N6A 5A5
      • Ottawa, Ontario, Canada, K1H 8L6
  • United States
    • California
      • La Jolla, California, United States, 92037-1030
    • Florida
      • Bradenton, Florida, United States, 34209
    • Georgia
      • Atlanta, Georgia, United States, 30309
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
      • Honolulu, Hawaii, United States, 96817
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Missouri
      • Kansas City, Missouri, United States, 64131
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • Bronx, New York, United States, 10468
      • New York, New York, United States, 10021
      • New York, New York, United States, 10003
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • South Carolina
      • Columbia, South Carolina, United States, 29204
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Houston, Texas, United States, 77030
      • 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

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients, 18-70 years of age
  • hepatitis C, genotype 1 or 4, of over 6 months duration
  • treatment-naïve
  • negative pregnancy test; female patients of childbearing age and male patients with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

Exclusion Criteria:

  • pregnant or breast feeding females or male partners of pregnant females
  • previous interferon or ribavirin based therapy or investigational anti-HCV agent
  • systemic antiviral therapy with established or perceived activity against HCV </=3 months prior to first dose of study drug
  • hepatitis A or B, or HIV infection
  • history or evidence of medical condition associated with chronic liver disease other than HCV

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
Intervention / Treatment
Experimental: Arm A: With RO5024048
Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily).
Drug: RO5024048
1000mg bid po, 24 weeks
Drug: Ribavirin [Copegus]
1000mg or 1200mg po daily
Drug: peginterferon alfa-2a [Pegasys]
180mcg sc weekly
Active Comparator: Arm B: Standard treatment
Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks.
Drug: Ribavirin [Copegus]
1000mg or 1200mg po daily
Drug: peginterferon alfa-2a [Pegasys]
180mcg sc weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained virological response (undetectable HCV DNA as measured by Roche COBAS TaqMan HCV test)
Time Frame: 24 weeks after last treatment dose
24 weeks after last treatment dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Virologic response over time
Time Frame: weeks 4, 12, 24, 36, 48 and 60
weeks 4, 12, 24, 36, 48 and 60
Pharmacokinetics of RO4995855 when RO5024048 is administered with peginterferon alfa-2a and ribavirin
Time Frame: week 12 and 24
week 12 and 24
Resistance profile of RO5024048
Time Frame: weeks 1-24
weeks 1-24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

February 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

January 26, 2010

First Submitted That Met QC Criteria

January 26, 2010

First Posted (Estimate)

January 27, 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

  • NV22621

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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