NCT01331850

A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C

A Randomized Open-label Study to Evaluate the Sustained Virologic Response of Danoprevir/Ritonavir and Copegus in Combination With RO5024048 and/or Pegasys in Chronic Hepatitis C Genotype 1 Patients Who Failed Previous Standard Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 381 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Copegus	1000 mg or 1200 mg daily oral doses for 24 weeks
DRUG	Copegus	1000 mg or 1200 mg daily oral doses for 48 weeks
DRUG	Pegasys	180 microgram subcutaneously once weekly for 24 weeks
DRUG	Pegasys	180 microgram subcutaneously once weekly for 48 weeks
DRUG	RO5024048	1000 mg oral doses twice a day for 24 weeks
DRUG	danoprevir	100 mg oral doses twice a day for 24 weeks
DRUG	ritonavir	100 mg oral doses twice a day for 24 weeks

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-04-08
• Last updated: 2016-11-02

Locations

67 sites across 13 countries: United States, Australia, Austria, Brazil, Canada, France, Germany, Italy, Mexico, Poland, Puerto Rico, Spain, United Kingdom