Protocol M12-999: Safety and Efficacy of the Combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 Coadministered with Ribavirin (RBV) in Adult Liver Transplant Recipients with Genotype 1 Hepatitis C Virus (HCV) Infection

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Investigator: Norah A. Terrault, MD
Sponsor: AbbVie Inc.

Location(s): United States

Description

The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir, ABT-267 (ABT-450/r/ABT-267) and ABT-333 co-administered with ribavirin in adult liver transplant recipients with hepatitis C virus (HCV) infection.

Inclusion Criteria:

  • Liver transplantation as a consequence of HCV infection no less than 12 months before screening.
  • Must have a liver biopsy which shows evidence of fibrosis <= F2 (Metavir scale) and which is obtained within the 6 months prior to the screening period but not less than 9 months post transplant or during the Screening Period
  • Chronic hepatitis C genotype 1 infection.
  • On an immunosuppressant regimen based on either tacrolimus or cyclosporine where the dose of immunosuppressant has not been increased at least 2 months before Screening and no new immunosuppressant drugs have been added for at leas 2 months before Screening.

Exclusion Criteria:

  • Positive hepatitis B surface antigen and anti-Human Immunodeficiency Virus Antibody.
  • Use of contraindicated medications within 2 weeks of dosing or 10 half-lives, whichever is longer.
  • Clinically significant abnormalities, other than HCV infection post transplant.
  • Recent history of drug or alcohol abuse.
  • Previous use of any investigational or commercially available anti-HCV agent other than interferon (IFN)-based therapy, i.e. conventional (c) IFN and/or pegylated (Peg) IFN, with or without RBV.