M15-410: ABT-493/530, Hep C patients who are prior DAA failures

• Research type

  Research Study

• Full title

  A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 (or ABT-493/ABT-530) With and Without Ribavirin in Adults With Chronic Hepatitis C Virus (HCV) Infection who Failed a Prior Direct-Acting Antiviral Agent (DAA)-Containing Therapy

• IRAS ID

  190901

• Contact name

  Stephen Ryder

• Contact email

  Stephen.Ryder@nuh.nhs.uk

• Sponsor organisation

  AbbVie Deutschland GmbH & Co.KG

• Eudract number

  2015-002350-13

• Clinicaltrials.gov Identifier

  NCT02446717

• Duration of Study in the UK

  1 years, 0 months, 23 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 have developed 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.

  DAAs are not guaranteed to be effective, some patients may fail treatment on these therapies, and HCV remains in the body. In this situation, these patients may become resistant to the DAA that was used, thereby limiting further treatment options.

  This study contains 2 parts. In the first part, effectiveness of the DAAs ABT-493/ABT-530 with and without ribavirin in subjects with GT 1 infection and who failed treatment with prior DAA was demonstrated. In this 2nd part of the study effectiveness of the ABT-493/ABT-530 medication over a 12 or 16 week period in adults with chronic HCV infection with genotype 1, 4, 5, or 6 will be tested. Subjects will be followed for 24 weeks after treatment.

  In Part 2, up to 80 subjects will be included across 40 sites worldwide. Subjects will attend regular study visits at clinics during the course of the study. Participation in the Part 2 will last up to 40 weeks. Safety and efficacy evaluations will occur throughout the study.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  16/NW/0064

• Date of REC Opinion

  25 Feb 2016

• REC opinion

  Further Information Favourable Opinion