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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00963885
• Other study ID #: NV21075
• Secondary ID: 2009-009608-38
• Status: Completed
• Phase: Phase 2
• First received: August 18, 2009
• Last updated: November 1, 2016
• Start date: August 2009
• Est. completion date: January 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 229
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• Copegus
1000 or 1200mg po daily for 24 or 48 weeks
• Pegasys
180micrograms sc weekly for 24 or 48 weeks
• Placebo
po for 12 weeks
• Placebo
po for 24 weeks
• RO5190591 (Danoprevir)
300mg po q8h for 12 weeks
• RO5190591 (Danoprevir)
600mg po q12h for 12 weeks
• RO5190591 (Danoprevir)
900mg po q12h for 12 weeks
• RO5190591 (Danoprevir)
300mg po q8h or 600mg po q12h or 900po q12h for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Canada,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sustained virological response		24 weeks after end of treatment	No
Secondary	Virological response over time		At 2- to 6-weekly intervals throughout study; at end of treatment; 12 weeks post-treatment	No
Secondary	Adverse events; laboratory parameters		Throughout study, laboratory parameters every 2 to 6 weeks	No