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A Study of RO5190591 (Danoprevir) in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1 Virus Infection

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ClinicalTrials.gov Identifier: NCT00963885
Recruitment Status : Completed
First Posted : August 24, 2009
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Copegus Drug: Pegasys Drug: Placebo Drug: RO5190591 (Danoprevir) Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 229 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio
Study Start Date : August 2009
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Part 1: Placebo
Placebo in combination with standard doses of Pegasys and Copegus.
Drug: Copegus
1000 or 1200mg po daily for 24 or 48 weeks
Drug: Pegasys
180micrograms sc weekly for 24 or 48 weeks
Drug: Placebo
po for 12 weeks
Experimental: Part 1: RO5190591 300mg po
RO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus.
Drug: Copegus
1000 or 1200mg po daily for 24 or 48 weeks
Drug: Pegasys
180micrograms sc weekly for 24 or 48 weeks
Drug: RO5190591 (Danoprevir)
300mg po q8h for 12 weeks
Experimental: Part 1: RO5190591 600mg po
RO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
Drug: Copegus
1000 or 1200mg po daily for 24 or 48 weeks
Drug: Pegasys
180micrograms sc weekly for 24 or 48 weeks
Drug: RO5190591 (Danoprevir)
600mg po q12h for 12 weeks
Experimental: Part 1: RO5190591 900mg po
RO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
Drug: Copegus
1000 or 1200mg po daily for 24 or 48 weeks
Drug: Pegasys
180micrograms sc weekly for 24 or 48 weeks
Drug: RO5190591 (Danoprevir)
900mg po q12h for 12 weeks
Placebo Comparator: Part 2: Placebo
If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive placebo in combination with standard doses of Pegasys and Copegus.
Drug: Copegus
1000 or 1200mg po daily for 24 or 48 weeks
Drug: Pegasys
180micrograms sc weekly for 24 or 48 weeks
Drug: Placebo
po for 24 weeks
Experimental: Part 2: RO5190591 300mg po
If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
Drug: Copegus
1000 or 1200mg po daily for 24 or 48 weeks
Drug: Pegasys
180micrograms sc weekly for 24 or 48 weeks
Drug: RO5190591 (Danoprevir)
300mg po q8h or 600mg po q12h or 900po q12h for 24 weeks


Outcome Measures

Primary Outcome Measures :
  1. Sustained virological response [ Time Frame: 24 weeks after end of treatment ]

Secondary Outcome Measures :
  1. Virological response over time [ Time Frame: At 2- to 6-weekly intervals throughout study; at end of treatment; 12 weeks post-treatment ]
  2. Adverse events; laboratory parameters [ Time Frame: Throughout study, laboratory parameters every 2 to 6 weeks ]

Eligibility Criteria

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:

  • adult patients, >=18 years of age;
  • chronic hepatitis C, genotype 1;
  • treatment-naive.

Exclusion Criteria:

  • liver cirrhosis and other forms of liver disease;
  • HIV infection;
  • hepatocellular cancer;
  • 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): NCT00963885


  Show 43 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00963885     History of Changes
Other Study ID Numbers: NV21075
2009-009608-38
First Posted: August 24, 2009    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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
Peginterferon alfa-2a
Interferon-alpha
Ribavirin
Lactams
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents