A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.

November 1, 2016 updated by: Hoffmann-La Roche

A Randomized, Double-blind Study to Evaluate the Safety and Tolerability of the HCV Polymerase Inhibitor Pro-drug in Combination With Pegasys, With or Without Copegus, Versus Pegasys Plus Copegus, in Treatment-naïve Patients With Chronic Hepatitis C, Genotype 1

This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week experimental period. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

107

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

  • Puerto Rico
      • Santurce, Puerto Rico, 00909
  • 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, 92103-8465
      • San Diego, California, United States, 92154
      • San Francisco, California, United States, 94115
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Bradenton, Florida, United States, 34209
      • Gainesville, Florida, United States, 32610-0214
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Michigan
      • Novi, Michigan, United States, 48377
    • New York
      • Manhasset, New York, United States, 11030
      • New York, New York, United States, 10029
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7584
    • Texas
      • Dallas, Texas, United States, 75203
      • Fort Sam Houston, Texas, United States, 78234-3879
    • Virginia
      • 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

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;
  • CHC without liver cirrhosis or incomplete/transition to liver cirrhosis, genotype 1;
  • chronic liver disease consistent with CHC.

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
Intervention / Treatment
Active Comparator: PEGASYS with COPEGUS
Drug: Copegus
1000/1200mg po daily for 4 weeks
Drug: PEGASYS
180 micrograms sc weekly for 4 weeks
Experimental: RO5024048 1500mg in combination with PEGASYS
Drug: PEGASYS
180 micrograms sc weekly for 4 weeks
Drug: RO5024048 1500mg
1500mg po bid for 4 weeks
Experimental: RO5024048 3000mg in combination with PEGASYS
Drug: PEGASYS
180 micrograms sc weekly for 4 weeks
Drug: RO5024048 3000mg
3000mg po bid for 4 weeks
Experimental: RO5024048 in combination with PEGASYS and COPEGUS
Drug: Copegus
1000/1200mg po daily for 4 weeks
Drug: PEGASYS
180 micrograms sc weekly for 4 weeks
Drug: RO5024048 1500mg
1500mg po bid for 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events (AEs) and laboratory parameters.
Time Frame: Week 4, 8 and Week 72
Week 4, 8 and Week 72

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma concentration of HCV polymerase inhibitor
Time Frame: Week 4 and 8
Week 4 and 8
Antiviral activity
Time Frame: Week 4, 8 and Week 72
Week 4, 8 and Week 72

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

September 1, 2006

Primary Completion (Actual)

August 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

September 15, 2006

First Submitted That Met QC Criteria

September 15, 2006

First Posted (Estimate)

September 18, 2006

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

  • PV18369

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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