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: August 26, 2014
Last verified: August 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

  Show 63 Study Locations
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: August 26, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 22, 2014