Dose-Ranging study of Albinterferon alfa-2b in Hepatitis C - Version 1

• Research type

  Research Study

• Full title

  An open-label, randomised, multicentre, active-controlled, dose-ranging study to evaluate the safety and efficacy of albinterferon alpha-2b administered every 4 weeks plus ribavirin in interferon alfa-naive patients with genotype 2/3 chronic hepatitis C.

• IRAS ID

  6181

• Contact name

  Marius Scholtz

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2008-002039-34

• ISRCTN Number

  n/a

• Research summary

  The overall aim of this research study is to develop a treatment for Chronic Hepatitis C (genotype 2/3) that's equally or more effective than current treatment, but also more convenient for patients. Currently, the standard treatment for patients with genotype 2/3 chronic hepatitis C involves weekly injections with anti-Hepatitis-C-Virus medication for 24 weeks (i.e. 24 injections in total). Novartis are hoping to develop a longer acting IFN-based compound, alb-IFN, that can be given once every 4 weeks for 24 weeks (i.e. 6 injections in total). In this study Novartis will be looking at up to 4 doses of the study drug, alb-IFN, to find out which is best for this 4-weekly regimen (i.e. which is the safest and most effective over the longer time period) (i.e. which is the safest and most effective over the longer time period). Patients will be treated with either the study drug, alb-IFN, or with the current standard treatment of Pegylated-Interferon (PEG-IFN). There will be a maximum of 5 treatment groups. Four of these treatment groups will be different doses of alb-IFN and the fifth will be the standard dose of PEG-IFN. Patients will be assigned to one of the 5 treatment groups by randomisation (where a computer randomly assigns a patient to a treatment group). All patients will also take daily Ribavirin (tablets) as per standard treatment practice. The study involves a 24 week treatment period and a 24 week follow-up period. The results of this study will provide information on the dose(s) to be investigated in future studies using the alb-IFN 4-weekly dosing schedule. The study will recruit 525 patients worldwide. In the UK, 60 patients will take part across 6 study centres. Novartis Pharma Services AG are sponsoring and funding this research study.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  08/H0604/150

• Date of REC Opinion

  20 Nov 2008

• REC opinion

  Further Information Favourable Opinion