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A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01331850
First received: March 28, 2011
Last updated: November 1, 2016
Last verified: November 2016
March 28, 2011
November 1, 2016
May 2011
January 2013   (Final data collection date for primary outcome measure)
  • Sustained virological response (SVR) of danoprevir/ritonavir with RO5024048 and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment [ Time Frame: 24 weeks ]
  • Sustained virological response (SVR) of danoprevir/ritonavir with Pegasys and Copegus in patients with previous partial response to peginterferon/ribavirin treatment [ Time Frame: 24 weeks ]
  • Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus in patients with previous partial or null response to peginterferon/ribavirin treatment [ Time Frame: 24 weeks ]
  • Sustained virological response (SVR) of danoprevir/ritonavir and RO5024048 with Pegasys and Copegus followed by 24 weeks of Pegasys and Copegus treatment in patients with previous null response to peginterferon/ribavirin treatment [ Time Frame: 48 weeks ]
Same as current
Complete list of historical versions of study NCT01331850 on ClinicalTrials.gov Archive Site
  • Safety (Incidence of adverse events) of danoprevir, RO5024048 and Copegus [ Time Frame: 48 weeks ]
  • Safety (Incidence of adverse events) of danoprevir, Pegasys and Copegus [ Time Frame: 48 weeks ]
  • Safety (Incidence of adverse events) of danoprevir, RO5024048, Pegasys and Copegus [ Time Frame: 72 weeks ]
  • Virological response over time [ Time Frame: 48 weeks ]
  • Change in danoprevir plasma concentration [ Time Frame: 24 weeks ]
  • Change in RO5024048 plasma concentration [ Time Frame: 24 weeks ]
  • Hepatitis C virus drug resistance profile [ Time Frame: 24 weeks ]
Same as current
Not Provided
Not Provided
 
A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C
A Randomized Open-label Study to Evaluate the Sustained Virologic Response of Danoprevir/Ritonavir and Copegus in Combination With RO5024048 and/or Pegasys in Chronic Hepatitis C Genotype 1 Patients Who Failed Previous Standard Therapy
This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: Copegus
    1000 mg or 1200 mg daily oral doses for 24 weeks
  • Drug: Copegus
    1000 mg or 1200 mg daily oral doses for 48 weeks
  • Drug: Pegasys
    180 microgram subcutaneously once weekly for 24 weeks
  • Drug: Pegasys
    180 microgram subcutaneously once weekly for 48 weeks
  • Drug: RO5024048
    1000 mg oral doses twice a day for 24 weeks
  • Drug: danoprevir
    100 mg oral doses twice a day for 24 weeks
  • Drug: ritonavir
    100 mg oral doses twice a day for 24 weeks
  • Experimental: Previous null responders (Cohort B): Group 4
    Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
    Interventions:
    • Drug: Copegus
    • Drug: RO5024048
    • Drug: danoprevir
    • Drug: ritonavir
  • Experimental: Previous null responders (Cohort B): Group 5
    Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 5 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
    Interventions:
    • Drug: Copegus
    • Drug: Pegasys
    • Drug: RO5024048
    • Drug: danoprevir
    • Drug: ritonavir
  • Experimental: Previous null responders (Cohort B): Group 6
    Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.
    Interventions:
    • Drug: Copegus
    • Drug: Pegasys
    • Drug: RO5024048
    • Drug: danoprevir
    • Drug: ritonavir
  • Experimental: Previous partial responders (Cohort A): Group 1
    Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 1 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
    Interventions:
    • Drug: Copegus
    • Drug: RO5024048
    • Drug: danoprevir
    • Drug: ritonavir
  • Experimental: Previous partial responders (Cohort A): Group 2
    Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
    Interventions:
    • Drug: Copegus
    • Drug: Pegasys
    • Drug: danoprevir
    • Drug: ritonavir
  • Experimental: Previous partial responders (Cohort A): Group 3
    Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. Group 3 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks.
    Interventions:
    • Drug: Copegus
    • Drug: Pegasys
    • Drug: RO5024048
    • Drug: danoprevir
    • Drug: ritonavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
381
January 2013
January 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, age 18 years and older
  • Presence of hepatitis C infection, genotype 1a or 1b
  • Documentation of previous treatment failure after receiving approved doses of peginterferon plus ribavirin for at least 12 weeks
  • Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to study start

Exclusion Criteria:

  • Infection with any hepatitis C genotype or subtype other than genotype 1a or 1b
  • Patients with cirrhosis
  • Patients who were discontinued from previous peginterferon plus ribavirin therapy due to reasons other than insufficient therapeutic response
  • Co-infection with hepatitis B or human immunodeficiency virus (HIV)
  • History or evidence of chronic liver disease other than hepatitis C
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Brazil,   Canada,   France,   Germany,   Italy,   Mexico,   Poland,   Puerto Rico,   Spain,   United Kingdom,   United States
 
 
NCT01331850
WV21913
2010-019585-90
Not Provided
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