M13-576: Follow-up for 2nd Gen DAA 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 (ABT-493 and/or ABT-530) in Subjects Who Participated in Phase 2 or 3 Clinical Studies for the Treatment of Chronic Hepatitis C Virus (HCV) Infection

• IRAS ID

  218822

• Contact name

  Kaushik Agarwal

• Contact email

  Kosh.agarwal@klc.ac.uk

• Sponsor organisation

  AbbVie Deutschland GmbH & Co. KG

• Eudract number

  2015-000452-24

• Duration of Study in the UK

  2 years, 10 months, 15 days

• Research summary

  Hepatitis C virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver) and liver cancer, and patients may then need a liver transplant.
  Drug companies are developing drugs called ‘Direct Acting Antiviral Agents’ (DAAs) which work by targeting the different stages of the virus lifecycle. DAAs provide an alternative option to injectable therapies for patients with HCV and are generally well tolerated.
  This is a long term follow up study that enrols subjects who previously participated in an AbbVie Phase 2 or Phase 3 study of the investigational HCV treatment ABT-493 and/or ABT-530. The purpose of the study is to determine if subjects who were successfully treated in the first study maintain the response and if patients who failed treatment in the first study develop and maintain resistance to the treatment. No AbbVie study drug will be administered in this study.

  Approximately 400 subjects will be included across approximately 35 sites worldwide. Subjects will attend study visits at Day 1, 3 months and then every 6 months thereafter during the course of the study. Participation in this study will last approximately 3 years. Safety and efficacy evaluations will occur throughout the study.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  17/LO/0444

• Date of REC Opinion

  5 May 2017

• REC opinion

  Further Information Favourable Opinion