Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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: September 1, 2016
Last verified: September 2016
  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
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: 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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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: September 1, 2016
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
Lactams
Ribavirin
Interferon-alpha
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
Anti-Bacterial Agents
Antimetabolites

ClinicalTrials.gov processed this record on September 30, 2016