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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: September 18, 2012
Last verified: September 2012
History of Changes

August 16, 2007
September 18, 2012
December 2007
January 2010   (final data collection date for primary outcome measure)
Sustained virological response (SVR) [ Time Frame: 24 weeks post treatment end (ie weeks 48 or 72) ] [ Designated as safety issue: No ]
Sustained virological response at 24 weeks post end of treatment.
Complete list of historical versions of study NCT00517439 on ClinicalTrials.gov Archive Site
  • 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 ]
Efficacy:Virological response over time; sustained virological response 12 weeks post treatment;relapse rate after end of treatment; antiviral activity (HCV RNA). Safety:AEs, lab parameters.
Not Provided
Not Provided
 
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.
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

This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple 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 Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard 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 medication, 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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: RO4588161
    1000mg po bid for 24 weeks
  • Drug: RO4588161
    500mg po bid for 24 weeks
  • Drug: RO4588161
    1500mg po bid for 24 weeks
  • Drug: Pegasys
    180 micrograms sc weekly for 24 weeks
  • Drug: Pegasys
    90 micrograms sc weekly for 24 weeks
  • Drug: Copegus
    1000/1200mg po daily for 24 weeks
  • Experimental: 1
    Interventions:
    • Drug: RO4588161
    • Drug: Pegasys
    • Drug: Copegus
  • Experimental: 2
    Interventions:
    • Drug: RO4588161
    • Drug: Pegasys
    • Drug: Copegus
  • Experimental: 3
    Interventions:
    • Drug: RO4588161
    • Drug: Pegasys
    • Drug: Copegus
  • Experimental: 4
    Interventions:
    • Drug: RO4588161
    • Drug: Pegasys
    • Drug: Copegus
  • Experimental: 5
    Interventions:
    • Drug: RO4588161
    • Drug: Pegasys
    • Drug: Copegus
  • Experimental: 6
    Interventions:
    • Drug: RO4588161
    • Drug: Pegasys
    • Drug: Copegus
  • Active Comparator: 7
    Interventions:
    • Drug: Pegasys
    • Drug: Copegus
Nelson DR, Zeuzem S, Andreone P, Ferenci P, Herring R, Jensen DM, Marcellin P, Pockros PJ, Rodríguez-Torres M, Rossaro L, Rustgi VK, Sepe T, Sulkowski M, Thomason IR, Yoshida EM, Chan A, Hill G. Balapiravir plus peginterferon alfa-2a (40KD)/ribavirin in a randomized trial of hepatitis C genotype 1 patients. Ann Hepatol. 2012 Jan-Feb;11(1):15-31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
516
January 2010
January 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Canada,   France,   Germany,   Italy,   Puerto Rico,   Spain
 
NCT00517439
NV19865
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP