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A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01749150
First received: December 11, 2012
Last updated: September 1, 2016
Last verified: September 2016
History of Changes

December 11, 2012
September 1, 2016
April 2013
February 2015   (final data collection date for primary outcome measure)
  • Safety: Incidence of adverse events [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir [ Time Frame: up to 14 days ] [ Designated as safety issue: No ]
  • Antiviral activity: Change in HCV RNA levels, measured using Roche COBAS TaqMan HCV Test v2.0 for High Pure System [ Time Frame: from baseline to Week 36/48 ] [ Designated as safety issue: No ]
  • Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01749150 on ClinicalTrials.gov Archive Site
  • Incidence of viral resistance to danoprevir [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Rapid virological response (RVR): Proportion of patients with undetectable HCV RNA at Week 4 [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Complete early virological response (cEVR): Proportion of patients with undetectable HCV RNA at Week 12 [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Sustained virological response 12 weeks after end of treatment (SVR-12), defined as unquantifiable HCV RNA 8-20 weeks after the last day of study drug administration [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Sustained virological response 24 weeks after end of treatment (SVR-24), defined as unquantifiable HCV RNA > 20 weeks after the last day of study drug administration [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • SVR measured as HCV RNA log10 IU/mL change from baseline to Week 12 [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis
STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTIVIRAL ACTIVITY OF RITONAVIR-BOOSTED DANOPREVIR IN COMBINATION WITH PEGINTERFERON ALFA-2A PLUS RIBAVIRIN IN TREATMENT-NAÏVE PATIENTS OF ASIAN ORIGIN WHO HAVE CHRONIC HEPATITIS C GENOTYPE 1 WITH OR WITHOUT COMPENSATED CIRRHOSIS
This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in treatment-naïve patients of Asian origin with chronic hepatitis C genotype 1. Patients will receive danoprevir 125 mg plus ritonavir 100 mg as fixed dose tablet orally twice daily in combination with weekly Pegasys 180 mcg subcutaneously and Copegus 1000-1200 mg orally daily in divided doses. Treatment duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with compensated cirrhosis.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis C, Chronic
  • Drug: danoprevir + ritonavir
    125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks
  • Drug: danoprevir + ritonavir
    125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 24 weeks
  • Drug: peginterferon alfa-2a [Pegasys]
    180 mcg sc weekly, 12 weeks
  • Drug: peginterferon alfa-2a [Pegasys]
    180 mcg sc weekly, 24 weeks
  • Drug: ribavirin [Copegus]
    1000-1200 mg orally daily in divided doses, 12 weeks
  • Drug: ribavirin [Copegus]
    1000-1200 mg orally daily in divided doses, 24 weeks
  • Experimental: with cirrhosis
    Interventions:
    • Drug: danoprevir + ritonavir
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: ribavirin [Copegus]
  • Experimental: without cirrhosis
    Interventions:
    • Drug: danoprevir + ritonavir
    • Drug: peginterferon alfa-2a [Pegasys]
    • Drug: ribavirin [Copegus]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
February 2015
February 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients of East Asian or Southeast Asian origin, >/= 18 years of age
  • Presence of chronic genotype 1 hepatitis C infection
  • Treatment-naïve

Exclusion Criteria:

  • History or presence of decompensated liver disease
  • Presence or history of non-hepatitis C chronic liver disease
  • Positive for hepatitis B or HIV infection
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of,   Taiwan,   Thailand
 
NCT01749150
YV28218
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
September 2016

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