Study in Naive G1&G4 Hep C Patients with Danoprevir/Ritonavir vs SOC

• Research type

  Research Study

• Full title

  A Randomized, Open label, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Protease Inhibitor Danoprevir (RO5190591) Boosted with Low Dose Ritonavir (danoprevir/r) in Combination with Pegasys® and Copegus® versus Pegasys® and Copegus® alone in Treatment-Naive Patients with Chronic Hepatitis C Genotype 1 or 4 Virus Infection

• IRAS ID

  59083

• Contact name

  Kosh Agarwal

• Sponsor organisation

  Roche Products Ltd

• Eudract number

  2010-019584-10

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Hepatitis C (HCV) is a viral infection which can lead to liver disease, liver failure and death. All participants on this study will have a particular form of the virus known as genotype 1 or genotype 4. The current approved standard treatment (SOC) for patients infected with HCV is a combination of two drugs called pegylated interferon (e.g. Pegasys) and ribavirin (e.g. Copegus) taken for 48 weeks. This study is investigating whether a new drug called danoprevir (taken with ritonavir to boost efficacy) when taken additionally to SOC in combination, will be more effective in achieving a sustained undetectable level of the virus in the blood than pegylated interferon and ribavirin alone. Participants who agree to take part in the study will be randomly assigned to one of 5 treatment groups. 4 out of 5 of these treatment groups will involve taking boosted danoprevir and SOC therapy with a different dose and duration depending on which group they are assigned to and whether they respond well or not to therapy. The final group will receive the standard approved treatment of Pegasys and Copegus alone. The effects of boosted danoprevir on the viral load will be monitored carefully at the clinic visits. All participants will be followed up for safety after treatment for 24 weeks. Patients who are assigned to the control group (who receive SOC) but who do not respond well enough to the combination therapy will be given the option to receive 24 weeks of boosted danoprevir and SOC.

• REC name

  Scotland A REC

• REC reference

  10/MRE00/69

• Date of REC Opinion

  22 Oct 2010

• REC opinion

  Further Information Favourable Opinion