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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00377182
First received: September 15, 2006
Last updated: August 26, 2014
Last verified: August 2014
  Purpose

This 4 arm study will compare the safety and tolerability of HCV polymerase inhi bitor 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 polymeras e inhibitor pro-drug + PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PE GASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All patients who receive at le ast one dose of study medication will receive open label PEGASYS + Copegus for a n 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 individua ls.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Copegus
Drug: PEGASYS
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
Drug: PEGASYS
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
Drug: PEGASYS
180 micrograms sc weekly for 4 weeks

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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, 92154
San Diego, California, United States, 92103-8465
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

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: August 26, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014