Trial record 1 of 1 for:    NCT01057667
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A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01057667
First received: January 26, 2010
Last updated: October 20, 2014
Last verified: October 2014

January 26, 2010
October 20, 2014
February 2010
April 2012   (final data collection date for primary outcome measure)
Sustained virological response (undetectable HCV DNA as measured by Roche COBAS TaqMan HCV test) [ Time Frame: 24 weeks after last treatment dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01057667 on ClinicalTrials.gov Archive Site
  • Virologic response over time [ Time Frame: weeks 4, 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
  • Pharmacokinetics of RO4995855 when RO5024048 is administered with peginterferon alfa-2a and ribavirin [ Time Frame: week 12 and 24 ] [ Designated as safety issue: No ]
  • Resistance profile of RO5024048 [ Time Frame: weeks 1-24 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4
A Randomized, Double-blinded, Multicenter Study to Evaluate the Antiviral Efficacy and Safety of Adding the HCV Polymerase Inhibitor Prodrug (RO5024048) for 24 Weeks to the Currently Approved Combination of Pegasys® and Copegus® in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 or 4

This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterfe ron alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twic e daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Cope gus (1000mg or 1200mg orally daily). Patients achieving a rapid virological resp onse (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for anoth er 24 weeks up to week 48. Patients in arm B will receive standard treatment wit h Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sam ple size is <200.

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: RO5024048
    1000mg bid po, 24 weeks
  • Drug: Ribavirin [Copegus]
    1000mg or 1200mg po daily
  • Drug: peginterferon alfa-2a [Pegasys]
    180mcg sc weekly
  • Experimental: A
    Interventions:
    • Drug: RO5024048
    • Drug: Ribavirin [Copegus]
    • Drug: peginterferon alfa-2a [Pegasys]
  • Active Comparator: B
    Interventions:
    • Drug: Ribavirin [Copegus]
    • Drug: peginterferon alfa-2a [Pegasys]
Tong X, Le Pogam S, Li L, Haines K, Piso K, Baronas V, Yan JM, So SS, Klumpp K, Nájera I. In vivo emergence of a novel mutant L159F/L320F in the NS5B polymerase confers low-level resistance to the HCV polymerase inhibitors mericitabine and sofosbuvir. J Infect Dis. 2014 Mar 1;209(5):668-75. doi: 10.1093/infdis/jit562. Epub 2013 Oct 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
April 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult patients, 18-70 years of age
  • hepatitis C, genotype 1 or 4, of over 6 months duration
  • treatment-naïve
  • negative pregnancy test; female patients of childbearing age and male patients with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

Exclusion Criteria:

  • pregnant or breast feeding females or male partners of pregnant females
  • previous interferon or ribavirin based therapy or investigational anti-HCV agent
  • systemic antiviral therapy with established or perceived activity against HCV </=3 months prior to first dose of study drug
  • hepatitis A or B, or HIV infection
  • history or evidence of medical condition associated with chronic liver disease other than HCV
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01057667
NV22621
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

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