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: August 26, 2014
Last verified: August 2014
  Purpose

This randomized, open-label, active-controlled, parallel-group study will evalua te the sustained virological response of danoprevir boosted with low dose ritona vir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegas ys and Copegus alone in treatment-naive patients with chronic Hepatitis C.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Copegus
Drug: daneprovir
Drug: danoprevir
Drug: peginterferon alfa-2a [Pegasys]
Drug: ritonavir
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: Copegus
repeated oral dose
Drug: danoprevir
repeated oral dose
Drug: peginterferon alfa-2a [Pegasys]
repeated subcutaneous injection
Drug: ritonavir
repeated oral dose
Experimental: B Drug: Copegus
repeated oral dose
Drug: danoprevir
repeated oral dose
Drug: peginterferon alfa-2a [Pegasys]
repeated subcutaneous injection
Drug: ritonavir
repeated oral dose
Experimental: C Drug: Copegus
repeated oral dose
Drug: danoprevir
repeated oral dose
Drug: peginterferon alfa-2a [Pegasys]
repeated subcutaneous injection
Drug: ritonavir
repeated oral dose
Experimental: D Drug: Copegus
repeated oral dose
Drug: daneprovir
repeated oral dose
Drug: peginterferon alfa-2a [Pegasys]
repeated subcutaneous injection
Drug: ritonavir
repeated oral dose
Active Comparator: E Drug: Copegus
repeated oral dose
Drug: peginterferon alfa-2a [Pegasys]
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 26, 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
Ritonavir
Peginterferon alfa-2a
Interferon-alpha
Ribavirin
Lactams
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014