WV21913 Study in Hepatitis C Patients who failed previous therapy

• Research type

  Research Study

• Full title

  A Randomised, Open-label, Multicentre Study to Evaluate the Sustained Virologic Response of the HCV Protease Inhibitor Danoprevir Boosted with Low Dose Ritonavir (DNV/r) and Copegus®, in Combination with the HCV Polymerase Inhibitor Prodrug RO5024048 and/or Pegasys® in Chronic Hepatitis C Genotype 1 Patients Who Failed with a Previous Course of Peginterferon alfa plus Ribavirin Combination Therapy.

• IRAS ID

  70597

• Contact name

  Ashley Brown

• Sponsor organisation

  Roche Products Ltd

• Eudract number

  2010-019585-90

• ISRCTN Number

  n/a

• Research summary

  Hepatitis C (HCV) is a viral infection. All participants on this study will have a particular form of the virus known as genotype 1. This is harder to treat than other genotypes. The current approved standard of care treatment (SOC) for patients infected with HCV is a combination of two drugs called pegylated interferon (PEG-IFN) and ribavirin (RBV). Achieving a sustained virological response,(SVR) which is a sustained undetectable level of the virus in the blood is the goal of treatment.This study is investigating whether new classes of drugs called direct acting antivirals, when added to existing treatment, will be effective in achieving a SVR, in patients who have failed previous therapy. Males and Females over the age of 18, who agree to take part in the study will be screened and those who qualify will be assigned to one of two groups depending upon when they were deemed to have failed treatment. Within the groups the patients are then randomly assigned to one of three treatment arms. Group A Danoprevir and Ritonavir and RO5024048 and RBV; orDanoprevir and Ritonavir and RBV plus PEG-IFN; orDanoprevir and Ritonavir and RO5024048 and RBV plus PEG-IFN. Group B Danoprevir and Ritonavir and RO5024048 and RBV; or Danoprevir and Ritonavir and RO5024048 plus PEG-IFN and RBV all for 24 weeks; or Danoprevir and Ritonavir and RO5024048 for 24 weeks plus PEG-IFN and RBV for 48 weeks. Treatment in the study is expected to last 24 weeks for 5 arms and 48 weeks for the 6th arm. All groups are followed up, treatment free, for 24 weeks after last dose. The effects on the viral load, as well as possible developing resistance to the study drug and other adverse events will be monitored throughout the study.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  11/LO/0278

• Date of REC Opinion

  5 May 2011

• REC opinion

  Favourable Opinion