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

Purpose

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	Intervention	Phase
Hepatitis C, Chronic	Drug: danoprevir Drug: Placebo Drug: Pegasys Drug: Copegus	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Sustained virological response [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Virological response over time [ Time Frame: At 2- to 6-weekly intervals throughout study; at end of treatment; 12 weeks post-treatment ] [ Designated as safety issue: No ]
Adverse events; laboratory parameters [ Time Frame: Throughout study, laboratory parameters every 2 to 6 weeks ] [ Designated as safety issue: No ]

Enrollment:	229
Study Start Date:	August 2009
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 (part 1)	Drug: danoprevir 300mg po q8h for 12 weeks Drug: Pegasys 180micrograms sc weekly for 24 or 48 weeks Drug: Copegus 1000 or 1200mg po daily for 24 or 48 weeks
Experimental: 2 (part 1)	Drug: danoprevir 600mg po q12h for 12 weeks Drug: Pegasys 180micrograms sc weekly for 24 or 48 weeks Drug: Copegus 1000 or 1200mg po daily for 24 or 48 weeks
Experimental: 3 (part 1)	Drug: danoprevir 900mg po q12h for 12 weeks Drug: Pegasys 180micrograms sc weekly for 24 or 48 weeks Drug: Copegus 1000 or 1200mg po daily for 24 or 48 weeks
Placebo Comparator: 4 (part 1)	Drug: Placebo po for 12 weeks Drug: Pegasys 180micrograms sc weekly for 24 or 48 weeks Drug: Copegus 1000 or 1200mg po daily for 24 or 48 weeks
Experimental: 5 (part 2)	Drug: danoprevir 300mg po q8h or 600mg po q12h or 900po q12h for 24 weeks Drug: Pegasys 180micrograms sc weekly for 24 or 48 weeks Drug: Copegus 1000 or 1200mg po daily for 24 or 48 weeks
Placebo Comparator: 6 (part 2)	Drug: Placebo po for 24 weeks Drug: Pegasys 180micrograms sc weekly for 24 or 48 weeks Drug: Copegus 1000 or 1200mg po daily for 24 or 48 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963885

Show 43 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:	NCT00963885 History of Changes
Other Study ID Numbers:	NV21075, 2009-009608-38
Study First Received:	August 18, 2009
Last Updated:	October 10, 2012
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
Protease Inhibitors
Ribavirin
Peginterferon alfa-2a
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antimetabolites

ClinicalTrials.gov processed this record on May 16, 2013