NCT00517439

A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection.

A Randomized, Double-blinded Study to Evaluate the Safety and Effect on Sustained Virological Response of HCV Polymerase Inhibitor Pro-drug in Combination With PEGASYS Plus Copegus, Compared With the Currently Approved Combination of PEGASYS Plus Copegus, in Treatment-naïve Patients With Chronic he

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 516 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or 180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks. Group 7 will receive standard of care (SOC) for 48 weeks. There will be a 24 week period of treatment-free follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Copegus	1000/1200mg po daily for 24 weeks
DRUG	Pegasys	180 micrograms sc weekly for 24 weeks
DRUG	Pegasys	90 micrograms sc weekly for 24 weeks
DRUG	RO4588161	1000mg po bid for 24 weeks
DRUG	RO4588161	500mg po bid for 24 weeks
DRUG	RO4588161	1500mg po bid for 24 weeks

Timeline

• Start date: 2007-12-01
• Primary completion: 2010-01-01
• Completion: 2010-01-01
• First posted: 2007-08-17
• Last updated: 2016-11-02

Locations

63 sites across 9 countries: United States, Australia, Austria, Canada, France, Germany, Italy, Puerto Rico, Spain