NCT01579019

A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C Genotype 1 Who Have Failed Prior HCV Protease Inhibitor Treatment

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized, double blind, phase II study will evaluate the efficacy and safety of two doses of RO5024048 in combination with ritonavir-boosted danoprevir and Pegasys (peginterferon alpha-2a) and Copegus (ribavirin) in patients who failed a prior protease inhibitor containing regimen with or without pegylated interferon. Patients will be randomized to receive either a 2-week lead-in of RO5024048 (1500 mg or 1000 mg orally twice daily) in combination with Pegasys (180 mcg subcutaneously weekly) and Copegus (1000 mg or 1200 mg orally daily) followed by 24 weeks of therapy with RO5024048 in combination with danoprevir (100 mg orally twice daily) plus ritonavir (100 mg orally twice daily) and Pegasys and Copegus (QUAD therapy), or 24 weeks of therapy with RO5024048 in combination with danoprevir plus ritonavir and Pegasys and Copegus (QUAD therapy). Anticipated time on study treatment is 24 or 26 weeks, with a treatment-free follow-up of 24 weeks.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	RO5024048	1500 mg po bid, 24 or 26 weeks
DRUG	RO5024048	1000 mg po bid, 24 or 26 weeks
DRUG	danoprevir	100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
DRUG	peginterferon alfa-2a [Pegasys]	180 mcg sc qw, 24 or 26 weeks
DRUG	ribavirin [Copegus]	1000 mg or 1200 mg po daily, 24 or 26 weeks
DRUG	ritonavir	100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26

Timeline

• Start date: 2012-07-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2012-04-17
• Last updated: 2016-11-02