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A Study of Mericitabine in Combination With Telaprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01482390
First received: November 28, 2011
Last updated: November 3, 2014
Last verified: November 2014

November 28, 2011
November 3, 2014
December 2011
January 2014   (final data collection date for primary outcome measure)
Sustained virological response 12 weeks after treatment (SVR-12) [ Time Frame: up to 60 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01482390 on ClinicalTrials.gov Archive Site
  • Sustained virological response 4 weeks after treatment (SVR-4) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Virologic response over time [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients who develop treatment resistance [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics: trough concentration of RO4995855 [ Time Frame: Day 1 and Week 8 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: trough concentration of RO5012433 [ Time Frame: Day 1 and Week 8 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: trough concentration of telaprevir [ Time Frame: Day 1 and Week 8 ] [ Designated as safety issue: No ]
  • Virologic response over time [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients who develop treatment resistance [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Safety (incidence of adverse events) [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics (concentration of RO4995855 (parent drug of RO5024048)) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Pharmacokinetics (concentration of telaprevir) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Mericitabine in Combination With Telaprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C
A PHASE II, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PARALLEL GROUP STUDY TO EVALUATE THE SUSTAINED VIROLOGIC RESPONSE OF THE HCV POLYMERASE INHIBITOR PRODRUG RO5024048 IN COMBINATION WITH TELAPREVIR AND PEGASYS®/COPEGUS® IN PATIENTS WITH CHRONIC HEPATITIS C GENOTYPE 1 VIRUS INFECTION WHO WERE PRIOR NULL RESPONDERS TO TREATMENT WITH PEGYLATED INTERFERON/RIBAVIRIN

This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in c ombination with telaprevir and Pegasys/Copegus in patients with chronic hepatiti s C infection. The anticipated time on study treatment is up to 48 weeks.

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: Copegus
    total daily dose of 1000 mg or 1200 mg for 24 weeks
  • Drug: Copegus
    total daily dose of 1000 mg or 1200 mg for 48 weeks
  • Drug: mericitabine
    1000 mg twice daily for 24 weeks
  • Drug: mericitabine
    1000 mg twice daily for 12 weeks
  • Drug: Pegasys
    180 microgram subcutaneous once weekly for 24 weeks
  • Drug: Pegasys
    180 microgram subcutaneous once weekly for 48 weeks
  • Drug: Placebo
    Placebo to RO5024048 for 12 weeks (weeks 12-24)
  • Drug: telaprevir
    750 mg three times daily for 12 weeks
  • Experimental: A
    Interventions:
    • Drug: Copegus
    • Drug: mericitabine
    • Drug: Pegasys
    • Drug: telaprevir
  • Experimental: B
    Interventions:
    • Drug: Copegus
    • Drug: mericitabine
    • Drug: Pegasys
    • Drug: telaprevir
  • Experimental: C
    Interventions:
    • Drug: Copegus
    • Drug: mericitabine
    • Drug: Pegasys
    • Drug: Placebo
    • Drug: telaprevir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
January 2014
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/=18 years of age
  • Chronic hepatitis C infection for at least 6 months duration
  • Hepatitis C genotype 1a or 1b
  • Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
  • Patients showed a previous null response to therapy as defined by < 2 log10 IU/ml decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

Exclusion Criteria:

  • Hepatitis C infection with a genotype other than genotype 1a or 1b
  • Body mass index <18 or >/=36
  • Hepatitis A, hepatitis B, or HIV infection
  • Herbal remedies </=1 month prior to the first dose of study drug
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Germany,   Italy,   Spain,   United Kingdom
 
NCT01482390
NV27779, 2011-002715-28
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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