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• Research type

  Research Study

• Full title

  A phase IV, open-label, multicentre, international trial of response guided treatment with directly observed pegylated interferon alfa 2b and self-administered ribavirin for patients with chronic HCV genotype 2 or 3 infection and ongoing injection drug use.

• IRAS ID

  86828

• Contact name

  Stephen Ryder

• Sponsor organisation

  University of New South Wales

• Eudract number

  2010-024557-36

• Clinicaltrials.gov Identifier

  NCT01364090

• Research summary

  The purpose is to investigate whether hepatitis C treatment can be shortened from the standard 24 weeks (standard duration) to 12 weeks (shortened duration) if a patient has a rapid response to the treatment. A rapid response is where there is no hepatitis C virus detectable in the blood after 4 weeks of treatment. The study will examine this in people who are infected with particular types of hepatitis C, genotype 2 or 3, and are current injection drug users. For the purpose of this study anyone who has injected drugs in the previous 12 weeks is considered to be a current injection drug user. The study will also look at whether supervising treatment increases the number of people who are successfully treated (called “clearing” the virus). Supervised treatment means that each week the injection of pegylated interferon alfa-2b is given in the medical clinic under the supervision of the nurse or doctor rather than being taken home and given by the patient.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  12/EM/0010

• Date of REC Opinion

  9 Feb 2012

• REC opinion

  Further Information Favourable Opinion