A Study of HCV Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus 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:
NCT00517439
First received: August 16, 2007
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This 7 arm study will determine the optimal treatment combination, based on effi cacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be ra ndomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive trip le combination treatment with HCV polymerase inhibitor pro-drug (at doses of 500

, 1000 or 1500mg po bid) plus PEGASYS (90 or 180 micrograms sc weekly) plus Cope gus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Stan dard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medicati on, and non-RVR patients will remain on triple combination for an additional 24 weeks. Group 7 will receive SOC for 48 weeks. There will be a 24 week period of treatment-free follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Copegus
Drug: Pegasys
Drug: RO4588161
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blinded Study to Evaluate the Safety and Effect on Sustained Virological Response of HCV Polymerase Inhibitor Pro-drug in Combination With PEGASYS Plus Copegus, Compared With the Currently Approved Combination of PEGASYS Plus Copegus, in Treatment-naïve Patients With Chronic he

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virological response (SVR) [ Time Frame: 24 weeks post treatment end (ie weeks 48 or 72) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Virological response over time [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • SVR [ Time Frame: 12 weeks post treatment end (ie weeks 36 or 60) ] [ Designated as safety issue: No ]
  • Relapse rate [ Time Frame: End of treatment (ie weeks 24 or 48) ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout treatment ] [ Designated as safety issue: No ]

Enrollment: 516
Study Start Date: December 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Copegus
1000/1200mg po daily for 24 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 weeks
Drug: RO4588161
1000mg po bid for 24 weeks
Experimental: 2 Drug: Copegus
1000/1200mg po daily for 24 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 weeks
Drug: RO4588161
500mg po bid for 24 weeks
Experimental: 3 Drug: Copegus
1000/1200mg po daily for 24 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 weeks
Drug: RO4588161
500mg po bid for 24 weeks
Experimental: 4 Drug: Copegus
1000/1200mg po daily for 24 weeks
Drug: Pegasys
90 micrograms sc weekly for 24 weeks
Drug: RO4588161
1500mg po bid for 24 weeks
Experimental: 5 Drug: Copegus
1000/1200mg po daily for 24 weeks
Drug: Pegasys
90 micrograms sc weekly for 24 weeks
Drug: RO4588161
1000mg po bid for 24 weeks
Experimental: 6 Drug: Copegus
1000/1200mg po daily for 24 weeks
Drug: Pegasys
90 micrograms sc weekly for 24 weeks
Drug: RO4588161
500mg po bid for 24 weeks
Active Comparator: 7 Drug: Copegus
1000/1200mg po daily for 24 weeks
Drug: Pegasys
180 micrograms sc weekly for 24 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;
  • chronic hepatitis C, genotype 1;
  • chronic liver disease consistent with CHC;
  • compensated liver disease.

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: NCT00517439

  Hide Study Locations
Locations
United States, Arizona
Phoenix, Arizona, United States, 85054
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
Englewood, Colorado, United States, 80110
United States, Florida
Bradenton, Florida, United States, 34209
Gainesville, Florida, United States, 32610-0214
Miami, Florida, United States, 33136-1051
United States, Illinois
Chicago, Illinois, United States, 60637
United States, Maryland
Baltimore, Maryland, United States, 21287
United States, Minnesota
Plymouth, Minnesota, United States, 55446
United States, New York
Bronx, New York, United States, 10468
Manhasset, New York, United States, 11030
New York, New York, United States, 10021
United States, North Carolina
Chapel Hill, North Carolina, United States, 27599-7584
United States, Ohio
Cincinnati, Ohio, United States, 45267-0595
United States, Oregon
Portland, Oregon, United States, 97239
United States, Pennsylvania
Hershey, Pennsylvania, United States, 17033
United States, Rhode Island
Providence, Rhode Island, United States, 02905
United States, Tennessee
Nashville, Tennessee, United States, 37211
United States, Texas
Dallas, Texas, United States, 75203
Fort Sam Houston, Texas, United States, 78234-3879
San Antonio, Texas, United States, 78215
United States, Utah
Salt Lake City, Utah, United States, 84121
United States, Virginia
Fairfax, Virginia, United States, 22031
Richmond, Virginia, United States, 23249
Australia
Adelaide, Australia, 5000
Greenslopes, Australia, 4120
Melbourne, Australia, 3004
Sydney, Australia, 2050
Sydney, Australia, 2145
Austria
Wien, Austria, 1090
Canada, Alberta
Calgary, Alberta, Canada, T2N 4N1
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Vancouver, British Columbia, Canada, V5Z 1H2
Canada, Ontario
Ottawa, Ontario, Canada, K1H 8L6
Toronto, Ontario, Canada, M5G 1L7
France
Clichy, France, 92118
Creteil, France, 94010
Marseille, France, 13285
Paris, France, 75651
Paris, France, 75014
Pessac, France, 33604
Vandoeuvre-les-nancy, France, 54511
Germany
Berlin, Germany, 13353
Frankfurt Am Main, Germany, 60590
Freiburg, Germany, 79106
Hamburg, Germany, 20246
Hannover, Germany, 30625
Köln, Germany, 50937
Italy
Bologna, Italy, 40138
Napoli, Italy, 80131
Torino, Italy, 10126
Puerto Rico
Santurce, Puerto Rico, 00909
Spain
Badalona, Spain, 08915
Barcelona, Spain, 08003
Madrid, Spain, 28222
Sevilla, Spain, 41014
Valencia, Spain, 46014
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00517439     History of Changes
Other Study ID Numbers: NV19865
Study First Received: August 16, 2007
Last Updated: October 6, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014