ABT493 and ABT530 with and without Ribavirin in HCV patients

• Research type

  Research Study

• Full title

  A Randomized, Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Coadministration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With Chronic Hepatitis C Virus (HCV) Genotype 2 or Genotype 3 Infection.

• IRAS ID

  166347

• Contact name

  David Mutimer

• Contact email

  david.mutimer@uhb.nhs.uk

• Sponsor organisation

  AbbVie Deutschland GmbH & Co. KG

• Eudract number

  2014-002927-90

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  The purpose of this study to is evaluate the effects of the study drugs ABT-493 and ABT-530, with or without RBV (Ribavirin), in people who have chronic hepatitis C virus (HCV) genotype 2 or genotype 3 infection. The study drugs are being studied to see if they provide an effective and safe treatment for patients with HCV.

  About 175 people with HCV will participate in this study. Participants will be asked to visit their study doctor 14 times over a period of up to 12 weeks.

  Participants will be assigned to one of the following treatment arms if they have HCV genotype 2:
  - Arm A: 300 mg ABT-493 and 120 mg ABT-530 for 12 weeks.
  - Arm B: 200 mg ABT-493 and 120 mg ABT-530 for 12 weeks.
  - Arm C: 200 mg ABT-493 and 120 mg ABT-530 and 1000 or 1200 mg (weight based) RBV for 12 weeks

  Participants with HCV genotype 2 have an equal chance of being assigned to any of arms A, B or C.

  Participants with HCV genotype 3 will be assigned to one of the following treatment arms:
  - Arm D: 300 mg ABT-493 and 120 mg ABT-530 for 12 weeks.
  - Arm E: 200 mg ABT-493 and 120 mg ABT-530 for 12 weeks.
  - Arm F: 200 mg ABT-493 and 120 mg ABT-530 and 1000 or 1200 mg (weight based) RBV
  - Arm G: 200 mg ABT-493 and 40 mg ABT-530 for 12 weeks.

  Participants with HCV genotype 3 have an equal chance of being assigned to any of arms D, E, F or G.

  A number of assessments will be performed during the study including physical examinations, measurements of body weight, blood pressure and pulse rate, blood tests, urine tests and electrocardiograms. An ECG is a standard tests that doctors use to monitor electrical activity of the heart. These assessments are performed as part of the evaluation to determine if the study drugs are effective and safe.

  The study will be run at approximately 6 centres in the UK and is sponsored by AbbVie.

• REC name

  West Midlands - Edgbaston Research Ethics Committee

• REC reference

  14/WM/1231

• Date of REC Opinion

  30 Jan 2015

• REC opinion

  Further Information Favourable Opinion