CDEB025A2312: Follow up study for DEB025 SVR24 Hepatitis C patients

• Research type

  Research Study

• Full title

  CDEB025A2312: A multi-centre 3-year follow-up study to assess the durability of sustained virologic response in Alisporivir-treated chronic Hepatitis C patients

• IRAS ID

  102421

• Contact name

  Raj Hanvesakul

• Sponsor organisation

  Novartis Pharma Services AG

• Eudract number

  2011-006131-38

• 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 treatment end. Though patients who achieve SVR24 are considered cured of infection, there is scientific evidence that the HCV in the blood may become detectable once again in the long-term. There is little long-term follow-up data available on patients after SVR24, so regulatory authorities have recommended long-term follow-up data be collected to ensure durability of response after SVR24, review liver function over time and observe the presence and/or persistence of viral mutations. This study is designed to capture long-term follow-up data for patients treated successfully with DEB025 (Alisporivir) in their original DEB025 study.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  12/SC/0185

• Date of REC Opinion

  1 Jun 2012

• REC opinion

  Further Information Favourable Opinion