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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01220947
First received: October 7, 2010
Last updated: April 7, 2014
Last verified: April 2014
  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: danoprevir
Drug: ritonavir
Drug: peginterferon alfa-2a [Pegasys]
Drug: Copegus
Drug: daneprovir
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: from baseline up to 72 weeks ] [ Designated as safety issue: No ]
  • Evaluation of relapse rate [ Time Frame: up to 24 weeks after end of treatment ] [ Designated as safety issue: No ]
  • Characterization of resistance profile (HCV RNA sequencing and/or phenotypic analyses) [ Time Frame: from baseline up to 72 weeks ] [ Designated as safety issue: No ]
  • Virological response at scheduled visits over time (HCV RNA measured by Roche COBAS TaqMan HCV test) [ Time Frame: From baseline up to 72 weeks ] [ Designated as safety issue: No ]
  • Evaluation of virological breakthrough (viral load rebound) rate [ Time Frame: up to 72 weeks ] [ Designated as safety issue: No ]
  • Evaluation of pharmacokinetics (serum concentrations assessed by validated methods) [ Time Frame: up to 72 weeks ] [ Designated as safety issue: No ]

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: A Drug: danoprevir
repeated oral dose
Drug: ritonavir
repeated oral dose
Drug: peginterferon alfa-2a [Pegasys]
repeated subcutaneous injection
Drug: Copegus
repeated oral dose
Experimental: B Drug: ritonavir
repeated oral dose
Drug: peginterferon alfa-2a [Pegasys]
repeated subcutaneous injection
Drug: Copegus
repeated oral dose
Drug: danoprevir
repeated oral dose
Experimental: C Drug: ritonavir
repeated oral dose
Drug: peginterferon alfa-2a [Pegasys]
repeated subcutaneous injection
Drug: Copegus
repeated oral dose
Drug: danoprevir
repeated oral dose
Experimental: D Drug: ritonavir
repeated oral dose
Drug: peginterferon alfa-2a [Pegasys]
repeated subcutaneous injection
Drug: Copegus
repeated oral dose
Drug: daneprovir
repeated oral dose
Active Comparator: E Drug: peginterferon alfa-2a [Pegasys]
repeated oral dose
Drug: Copegus
repeated oral dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220947

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01220947     History of Changes
Other Study ID Numbers: NV22776, 2010-019584-10
Study First Received: October 7, 2010
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Ribavirin
Ritonavir
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Anti-HIV Agents
Anti-Retroviral Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014