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A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01220947
First Posted: October 14, 2010
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.

Condition Intervention Phase
Hepatitis C, Chronic Drug: Copegus Drug: Danoprevir Drug: Pegasys Drug: Ritonavir Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virological response (HCV RNA measured by Roche COBAS TaqMan HCV test) [ Time Frame: 24 weeks after end of treatment ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: from baseline up to 72 weeks ]
  • Evaluation of relapse rate [ Time Frame: up to 24 weeks after end of treatment ]
  • Characterization of resistance profile (HCV RNA sequencing and/or phenotypic analyses) [ Time Frame: from baseline up to 72 weeks ]
  • Virological response at scheduled visits over time (HCV RNA measured by Roche COBAS TaqMan HCV test) [ Time Frame: From baseline up to 72 weeks ]
  • Evaluation of virological breakthrough (viral load rebound) rate [ Time Frame: up to 72 weeks ]
  • Evaluation of pharmacokinetics (serum concentrations assessed by validated methods) [ Time Frame: up to 72 weeks ]

Enrollment: 421
Study Start Date: November 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Danoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Drug: Copegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Drug: Danoprevir
Danoprevir 200 mg BID
Drug: Pegasys
Pegasys 180 microgram sc qw
Drug: Ritonavir
Ritonavir 100 mg
Experimental: Group B
Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Drug: Copegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Drug: Danoprevir
Danoprevir 100 mg BID
Drug: Pegasys
Pegasys 180 microgram sc qw
Drug: Ritonavir
Ritonavir 100 mg
Experimental: Group C
Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Drug: Copegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Drug: Danoprevir
Danoprevir 50 mg BID
Drug: Pegasys
Pegasys 180 microgram sc qw
Drug: Ritonavir
Ritonavir 100 mg
Experimental: Group D
Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks
Drug: Copegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Drug: Danoprevir
Danoprevir 100 mg BID
Drug: Pegasys
Pegasys 180 microgram sc qw
Drug: Ritonavir
Ritonavir 100 mg
Active Comparator: Group E
Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 48 weeks
Drug: Copegus
Copegus 1000 mg or 1200 mg po daily for 24 weeks.
Drug: Pegasys
Pegasys 180 microgram sc qw

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults patients, >/=18 years of age
  • Chronic Hepatitis C, Genotype 1 and 4
  • HCV RNA >/=50,000 IU/mL
  • treatment-naive

Exclusion Criteria:

  • Patients with cirrhosis or incomplete/transition to cirrhosis
  • Patients with other forms of liver disease, HIV infection, hepatocellular carcinoma or severe cardiac disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220947


  Show 68 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01220947     History of Changes
Other Study ID Numbers: NV22776
2010-019584-10
First Submitted: October 7, 2010
First Posted: October 14, 2010
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Ritonavir
Peginterferon alfa-2a
Interferon-alpha
Ribavirin
Lactams
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Anti-Bacterial Agents