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2 Roche Studies of 3 or 4 HCV drugs: 1st study is 3 drug regimen- protease danoprevir/r boosted + R7128 polymerase+ribavirin; 2nd study is 3 or 4 drug regimens including danoprevir/r boosted+R7128 & various combinations of ribavirin or Pegasys/Rbv
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A Study on The Combination of RO5024048 And Ritonavir-Boosted Danoprevir With And Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)
This study is currently recruiting participants.
Verified on April 2011 by Hoffmann-La Roche
This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1 who are treatment-naïve for interferons. Patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response, the assigned treatment will be continued for a further 12 weeks. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up.
A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C
This study is not yet open for participant recruitment.
Verified on May 2011 by Hoffmann-La Roche
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.
Danoprevir/r Week 12 & R7128 phase 2b results Presented at EASL:
Antiviral activity, safety, and pharmacokinetics of danoprevir/ritonavir plus PEG-IFN α-2a/RBV in hepatitis C patients - pdf attached - (04/04/11)
EASL: Activity of danoprevir plus low-dose ritonavir in combination with peginterferon alfa-2a (40KD) plus ribavirin in previous null responders - (04/01/11) danoprevir/r + Peg/Rbv in null responders: 88% undetectable at week 12
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