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

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ClinicalTrials.gov Identifier: NCT00377182
Recruitment Status : Completed
First Posted : September 18, 2006
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

September 15, 2006
September 18, 2006
November 2, 2016
September 2006
August 2008   (Final data collection date for primary outcome measure)
Adverse events (AEs) and laboratory parameters. [ Time Frame: Week 4, 8 and Week 72 ]
Safety and tolerability at week 8
Complete list of historical versions of study NCT00377182 on ClinicalTrials.gov Archive Site
  • Plasma concentration of HCV polymerase inhibitor [ Time Frame: Week 4 and 8 ]
  • Antiviral activity [ Time Frame: Week 4, 8 and Week 72 ]
Plasma concentrations of HCV polymerase inhibitor; antiviral activity; antiviral resistance.
Not Provided
Not Provided
 
A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: Copegus
    1000/1200mg po daily for 4 weeks
  • Drug: PEGASYS
    180 micrograms sc weekly for 4 weeks
  • Drug: RO5024048 1500mg
    1500mg po bid for 4 weeks
  • Drug: RO5024048 3000mg
    3000mg po bid for 4 weeks
  • Active Comparator: PEGASYS with COPEGUS
    Interventions:
    • Drug: Copegus
    • Drug: PEGASYS
  • Experimental: RO5024048 1500mg in combination with PEGASYS
    Interventions:
    • Drug: PEGASYS
    • Drug: RO5024048 1500mg
  • Experimental: RO5024048 3000mg in combination with PEGASYS
    Interventions:
    • Drug: PEGASYS
    • Drug: RO5024048 3000mg
  • Experimental: RO5024048 in combination with PEGASYS and COPEGUS
    Interventions:
    • Drug: Copegus
    • Drug: PEGASYS
    • Drug: RO5024048 1500mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
Not Provided
August 2008
August 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Puerto Rico,   United States
 
 
NCT00377182
PV18369
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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