NV27779 Quad therapy in Hep C prior null responder patients

• Research type

  Research Study

• Full title

  A Phase II, Randomised, Double-Blind, MultiCentre, Active-Controlled,Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination with Telaprevir and Pegasys®/Copegus® compared with Telaprevir and Pegasys®/Copegus® in patients with Chronic Hepatitis C Genotype 1 Virus Infection who were prior null responders to treatment with Pegylated Interferon/Ribavirin.

• IRAS ID

  87274

• Contact name

  Kosh Agarwal

• Eudract number

  2011-002715-28

• ISRCTN Number

  Unknown

• Research summary

  All participants on this study will have a particular form of the Hepatitis C (HCV) virus known as genotype 1. Hepatitis C (HCV) is a viral infection and accounts for 70% of cases of chronic hepatitis C (CHC) in the United States and Western Europe. HCV geneotype 1 is the major geneotype accounting for the majority of CHC cases and is the most difficult to treat. Before the recent approval of a new class of drug called direct acting antivirals (DAAs) e.g.,Telaprevir, the first line of treatment for patients with HCV was a combination of two drugs called pegylated interferon (PEG-IFN) and ribavirin (RBV),Pegasys/Copegus. Achieving a sustained virological response,(SVR) which is a sustained undetectable level of the virus in the blood 12 weeks after treatment is the goal of treatment. Approximately 50% of patients are able to achieve an SVR with first line treatment. Re-treatment of patients who have previously failed a course of PEG-IFN/RBV (null responders), with a further course of PEG-IFN/RBV has met with limited success.This study evaluates the SVR achieved using a combination of 4 treatment therapies; two DAA's in combination with the first line treatment regimen PEG-IFN and RBV, in patients with CHC who are null responders. Patients who qualify will be randomly assigned to one of four treatment groups. Group A R05024048 telaprevir Pegasys/Copegus for 12 weeks R05024048 Pegasys/Copegus for 12 weeks Group B Same as Group A Pegasys/Copegus for 24 weeks Group CR05024048 telaprevir Pegasys/Copegus for 12 weeks R05024048 placebo Pegasys/Copegus for 12 weeks Pegasys/Copegus for 24 weeks Group D (control Group) R05024048 placebo telaprevir Pegasys/Copegus for 12 weeks R05024048 placebo Pegasys/Copegus for 12 weeks Pegasys/Copegus for 24 weeks All patients are followed up treatment free for 24 weeks following last dose of study medication.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/1739

• Date of REC Opinion

  9 Dec 2011

• REC opinion

  Further Information Favourable Opinion