An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Intervention: Telaprevir; Ribavirin; Pegylated Interferon Alfa-2a; Immunosuppressant Regimen
Intervention description: Tablet; Tablet; Subcutaneous Injection; Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice. Immunosuppressant regimen were not considered study drugs.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Immunosuppressive Agents
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To assess efficacy of telaprevir, pegylated interferon alfa-2a (Peg-IFN-alfa-2a), and
      ribavirin (RBV) for hepatitis C virus (HCV) in a 48-week total treatment duration regimen
      following liver transplantation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female participants between the ages of 18 and 65 years

          -  History of orthotopic liver transplantation less than 10 years before the Screening
             visit but no sooner than 6 months before Day 1

          -  Taking a stable immunosuppressant regimen based on either tacrolimus or cyclosporine
             without substantial dose changes over the past 3 months

          -  Naive to pegylated interferon/ribavirin treatment or experienced with pegylated
             interferon/ribavirin prior to transplantation with relapse, partial, or null response

        Exclusion Criteria:

          -  Documented cirrhosis after liver transplantation

          -  Ascites or hepatic encephalopathy within 6 months before Screening

          -  Retransplantation for recurrent hepatitis C

          -  Treatment for hepatitis C post liver transplantation

          -  History within the past 3 months of: rejection within 3 months or greater than (>) 1
             rejection within 12 months

          -  Current treatment with sirolimus or methylprednisolone. Low dose prednisone use (<5
             milligram per day) is permitted

          -  History within 3 months of any bacterial infection requiring >1 week of intravenous
             antibiotics, cytomegalovirus viremia or cytomegalovirus infection with end-organ
             involvement, fungal disease (except cutaneous and mild oral thrush)

          -  History of post transplant lymphoproliferative disease

          -  Acceptable laboratory values at Screening as specified in the protocol

          -  Positive for human immunodeficiency virus 1/2 (HIV1/2) enzyme immunoassay (EIA)
             antibody screen or Hepatitis B deoxyribonucleic acid (DNA) or Hepatitis B surface
             antigen

          -  History of hepatocellular carcinoma with high risk of recurrence

          -  Any other cause of liver disease deemed clinically significant by the investigator in
             addition to hepatitis C

          -  Autoimmune-mediated disease

          -  History of acute pancreatitis within 5 years before the Screening visit

          -  Prior treatment with an hepatitis C virus (HCV) protease inhibitor