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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: September 15, 2006
Last updated: May 4, 2016
Last verified: May 2016
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.

Condition Intervention Phase
Hepatitis C, Chronic
Drug: Copegus
Drug: RO5024048
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • AEs and laboratory parameters. [ Time Frame: Week 4, 8 and Week 72 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma concentration of HCV polymerase inhibitor [ Time Frame: Week 4 and 8 ] [ Designated as safety issue: No ]
  • Antiviral activity [ Time Frame: Week 4, 8 and Week 72 ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: September 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PEGASYS
180 micrograms sc weekly for 4 weeks
Drug: RO5024048
1500mg po bid for 4 weeks
Experimental: 2 Drug: PEGASYS
180 micrograms sc weekly for 4 weeks
Drug: RO5024048
3000mg po bid for 4 weeks
Experimental: 3 Drug: Copegus
1000/1200mg po daily for 4 weeks
180 micrograms sc weekly for 4 weeks
Drug: RO5024048
1500mg po bid for 4 weeks
Active Comparator: 4 Drug: Copegus
1000/1200mg po daily for 4 weeks
180 micrograms sc weekly for 4 weeks


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00377182

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
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Florida
Bradenton, Florida, United States, 34209
Gainesville, Florida, United States, 32610-0214
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Michigan
Novi, Michigan, United States, 48377
United States, New York
Manhasset, New York, United States, 11030
New York, New York, United States, 10029
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599-7584
United States, Texas
Dallas, Texas, United States, 75203
Fort Sam Houston, Texas, United States, 78234-3879
United States, Virginia
Richmond, Virginia, United States, 23249
Puerto Rico
Santurce, Puerto Rico, 00909
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00377182     History of Changes
Other Study ID Numbers: PV18369 
Study First Received: September 15, 2006
Last Updated: May 4, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Peginterferon alfa-2a
Anti-Infective Agents
Antiviral Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 24, 2016