A Study to Evaluate Chronic Hepatitis C Infection in Adult Transplant Recipients
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ombitasvir/paritaprevir/ritonavir and dasabuvir; ombitasvir/paritaprevir/ritonavir; ribavirin
Intervention description: Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet; Tablet; ombitasvir coformulated with paritaprevir and ritonavir; tablet
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis C Genotype 4; Chronic Hepatitis; Interferon-Free; Hepatitis C Virus (HCV); Renal Transplant; Liver Transplant; Hepatitis C Genotype 1

Summary:

      The purpose of this study is to evaluate the safety and efficacy of ABT-450/r/ABT-267 with or
      without ABT-333 and with or without ribavirin (RBV) in adult liver or renal transplant
      recipients with hepatitis C virus (HCV) genotype 1 or 4 (GT1 or GT4) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, at least 18 years of age at the time of screening.

          -  Currently taking an immunosuppressant regimen based on either tacrolimus or
             cyclosporine. Corticosteroids such as prednisone or prednisolone are permitted as
             components of the immunosuppressant regimen providing the dose is not more than 10
             mg/day.

          -  Hepatitis C virus (HCV) interferon (IFN) therapy treatment-naïve or -experienced,
             either pre- or post-liver or renal transplant.

          -  Screening HCV genotype testing indicating infection with genotype 1 or 4 (GT1 or GT4)
             only.

        Exclusion Criteria:

          -  Use of everolimus or sirolimus as part of the immunosuppressive regimen within 2
             months of Screening Visit.

          -  Use of any medications contraindicated for use with the study regimen as well as those
             that are contraindicated for use with either ritonavir or ribavirin within 2 weeks
             prior to study drugs administration or 10 half-lives (if known), whichever is longer.

          -  Positive test result for Hepatitis B surface antigen (HBsAg) or anti-human
             immunodeficiency virus antibody (HIV Ab).

          -  Documented history of post-transplant complications directly involving the hepatic or
             renal vasculature as appropriate to the organ transplanted, e.g., thrombosis of the
             portal vein, the hepatic artery and/or hepatic vein.

          -  Clinically significant abnormalities, other than HCV infection, in a subject
             post-transplant based upon the medical history, physical examination, vital signs,
             laboratory profile and a 12-lead electrocardiogram (ECG) that make the subject an
             unsuitable candidate for this study in the opinion of the investigator.