DEB025 in chronic hepatitis C G2/3 treatment naive patients

• Research type

  Research Study

• Full title

  A multicentre, randomised, open label, parallel-group phase IIB study on the efficacy and safety of oral regimens of DEB025 alone or in combination with ribavirin versus Standard of Care (peg-IFNalpha-2-a plus ribavirin) in treatment-naive hepatitis C genotype 2 and 3 patients.

• IRAS ID

  60039

• Contact name

  Marius Scholtz

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2010-020034-26

• ISRCTN Number

  n/a

• Research summary

  The overall aim of this research study is to develop a treatment for Chronic Hepatitis C Virus (HCV) infection that's equally or more effective than the treatments currently available, but that's more convenient for patients - thus also improving patient compliance. Currently, the standard treatment for patients with genotype 2/3 chronic HCV involves weekly injections with an anti-HCV medication (Pegylated-Interferon-alpha2a: PEG-IFN) for 24 weeks plus daily oral treatment with another anti-HCV medication - Ribavirin (RBV) for the 24 week period. Unfortunately, treatment outcome for patients treated with SOC is suboptimal. This is due to the fact that many patients cannot be treated for the recommended time period because of intolerance and side effects to either interferon or RBV. There is thus a need to develop a more tolerable treatment for these patients, with equal or superior efficacy. This study will explore whether the study drug - DEB025 - alone or in combination with either RBV or PEG-IFN will achieve higher rates of on-treatment and sustained SVR compared to SOC. The study drug - DEB025 (alisporivir) - is an orally available cyclophilin inhibitor that has shown strong anti-HCV activity in clinical studies. DEB025 has been shown to be active as monotherapy (i.e. when used on it's own) and has also been shown to be more effective when combined with PEG-IFN and PEG-IFN plus RBV. This study is a phase IIB study comparing DEB025 monotherapy, DEB025 600mg + PEG-IFN and 2 doses of DEB025 (600mg or 800mg) + RBV to Standard of Care. Approximately 400 treatment-naive HCV genotype 2/3 patients will be randomised into the study, of which 40 will recruited across 6 sites in the UK.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  10/H0806/92

• Date of REC Opinion

  25 Oct 2010

• REC opinion

  Further Information Favourable Opinion