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

Phase 2

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: Copegus; Drug: Pegasys; Drug: RO5190591 (Danoprevir); Drug: Placebo

• Registration Number: NCT00963885
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-18
• Study First Submitted QC: 2009-08-21
• Study First Posted: 2009-08-24
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Disposition First Submitted: 2016-07-07
• Disposition First Submitted QC: 2016-07-07
• Disposition First Posted: 2016-07-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 229

Inclusion Criteria

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

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Exclusion Criteria

• liver cirrhosis and other forms of liver disease;
• HIV infection;
• hepatocellular cancer;
• cardiac disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part 1: RO5190591 300mg po	RO5190591 (Danoprevir)	RO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus.
Part 1: Placebo	Copegus	Placebo in combination with standard doses of Pegasys and Copegus.
Part 1: Placebo	Placebo	Placebo in combination with standard doses of Pegasys and Copegus.
Part 1: RO5190591 600mg po	Copegus	RO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
Part 1: RO5190591 600mg po	Pegasys	RO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
Part 1: RO5190591 600mg po	RO5190591 (Danoprevir)	RO5190591 600mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
Part 1: RO5190591 900mg po	Copegus	RO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
Part 1: RO5190591 900mg po	RO5190591 (Danoprevir)	RO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
Part 2: Placebo	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 placebo in combination with standard doses of Pegasys and Copegus.
Part 2: Placebo	Pegasys	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.
Part 2: Placebo	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.
Part 2: RO5190591 300mg po	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 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.
Part 2: RO5190591 300mg po	Pegasys	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.
Part 2: RO5190591 300mg po	RO5190591 (Danoprevir)	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.
Part 1: Placebo	Pegasys	Placebo in combination with standard doses of Pegasys and Copegus.
Part 1: RO5190591 300mg po	Pegasys	RO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus.
Part 1: RO5190591 900mg po	Pegasys	RO5190591 900mg po every 12 hours in combination with standard doses of Pegasys and Copegus.
Part 1: RO5190591 300mg po	Copegus	RO5190591 300mg po every 8 hours in combination with standard doses of Pegasys and Copegus.

Primary Outcome Measures

Name	Time	Method
Sustained virological response	24 weeks after end of treatment

Secondary Outcome Measures

Name	Time	Method
Virological response over time	At 2- to 6-weekly intervals throughout study; at end of treatment; 12 weeks post-treatment
Adverse events; laboratory parameters	Throughout study, laboratory parameters every 2 to 6 weeks