CDEB025A2313:Follow up study for DEB025 SVR24-fail Hepatitis C patient

• Research type

  Research Study

• Full title

  CDEB025A2313: A multi-centre 3-year follow-up study to assess the viral activity in patients who failed to achieve sustained virologic response in Novartis-sponsored Alisporivir-studies for chronic Hepatitis C patients

• IRAS ID

  103455

• Contact name

  Raj Hanvesakul

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-006132-24

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The primary goal of chronic hepatitis C treatment is sustained virologic response (SVR24), which is defined as the achievement of undetectable Hepatitis C virus (HCV) in the blood at 24 weeks after the treatment end. Unfortunately some patients do not achieve SVR24 during treatment as their HCV does not clear significantly or returns very quickly after being cleared. There is little long-term follow-up data available on patients who fail to achieve SVR24, so regulatory authorities have recommended these patients should be monitored for a longer period of time with the aim to understand the virus behaviour and/or long-term persistence of drug-resistant virus after treatment has been stopped. This study is designed to capture long-term follow-up data for patients who did not respond successfully with DEB025 (Alisporivir) in their original DEB025 study.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  12/SC/0184

• Date of REC Opinion

  1 Jun 2012

• REC opinion

  Further Information Favourable Opinion