An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients

• Status: Terminated
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Treatments: Cyclosporine; Cyclosporins; Immunosuppressive Agents; Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin; Tacrolimus

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