M13-102: Follow-up study for DAA therapies in previous HCV studies

• Research type

  Research Study

• Full title

  A Follow-up Study to Assess Resistance and Durability of Response to AbbVie Direct-Acting Antiviral Agent (DAA) Therapy in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection

• IRAS ID

  133018

• Contact name

  Geoffrey Dusheiko

• Contact email

  g.dusheiko@ucl.ac.uk

• Sponsor organisation

  AbbVie

• Eudract number

  2012-003073-26

• Research summary

  Hepatitis C viral (HCV) infection is the most common cause of chronic liver disease worldwide with an estimated 170 million people infected. HCV predominantly affects liver cells which causes the liver to become inflamed and damaged. If the disease progresses it can result in damage to the digestive system, the immune system (how your body fights off illnesses) and the brain. Current treatment options available have improved in recent years, however these treatments can cause significant side effects, resulting in patients stopping their treatment before they have
  been cured of the virus. As such there is still a clear need to develop treatments for hepatitis C that can be better tolerated.

  Drug companies are developing drugs which act directly on the virus. These drugs called ‘Direct Acting Antiviral Agents’ (DAAs) work by targeting the different stages of the virus lifecycle. AbbVie has three DAAs in development (ABT450/
  r, ABT267 and ABT333).

  This study will follow patients from previous AbbVie Hep C studies who have been treated with these DAAs to check that the response by the patients to the drugs is sustained over the long term and the amount of hepatitis C virus in the blood remains undetectable.

  The study will be conducted in clinics in the UK. Subjects will attend regular study visits every three months at clinics over a three year period. The long term effect of the DAAs on the virus will be checked by performing blood tests and collecting information where applicable.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  13/LO/1290

• Date of REC Opinion

  22 Oct 2013

• REC opinion

  Further Information Favourable Opinion