M13-101: DAAs and pegIFN/RBV for treatment failure in chronic Hep C

• Research type

  Research Study

• Full title

  An Open-Label Study to Evaluate the Safety, Antiviral Activity and Pharmacokinetics of Direct Acting Antiviral Agent (DAA) Treatment in Combination with Peginterferon a-2a and Ribavirin (pegIFN/RBV) in Chronic Hepatitis C Virus (HCV) Infected Subjects Who Have Experienced Virologic Failure in a Previous Abbott DAA Combination Study.

• IRAS ID

  103253

• Contact name

  Kosh Agarwal

• Sponsor organisation

  Abbott GmbH & Co. KG

• Eudract number

  2011-005393-32

• Research summary

  Chronic Hepatitis C Virus (HCV)infection is a leading cause of chronic liver disease including cirrhosis and liver cancer. The current treatment options have significant side effects which may cause treatment to be stopped before HCV has been eliminated. For these reasons, Abbott currently has a number of drugs in development for HCV that work directly on the virus called Direct Acting Antivirals (DAAs). Since these drugs are in development, it is possible that the regimens being tested in ongoing studies will not work for some patients, so Abbott has designed this 'rescue' study to give patients an opportunity to try a high intensity regimen with the hope that this regimen might clear the virus in patients where DAAs alone have failed. All patients will receive the Standard of Care treatment - Pegylated Interferon and Ribavirin with 2 of the Abbott DAAs - ABT450/r and ABT267 for 24 weeks, followed by a further 24 weeks of Peg IFN and RBV and then a follow up period to check that the virus has cleared for 48 weeks. Patients will visit the site as an outpatient for the duration of the study where they will have physical examination, blood tests, urinalysis and ECG to monitor their health and wellbeing and the status of their HCV. Patients will be able to take part in this study if they have HCV infection and have failed previous therapy with an Abbott DAA only regimen.

• REC name

  London - Bloomsbury Research Ethics Committee

• REC reference

  12/LO/0858

• Date of REC Opinion

  10 Aug 2012

• REC opinion

  Further Information Favourable Opinion