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

Vertex Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Hepatitis C

Treatments: Drug: Telaprevir; Drug: Immunosuppressant Regimen; Drug: Pegylated Interferon Alfa-2a; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01467505

VX11-950-117

Details and patient eligibility

About

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.

Enrollment: 61 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 2 patient groups

T/PR + Immunosuppressant Regimen (Tacrolimus)

Experimental group

Description:

Participants who were receiving tacrolimus (TAC) based immunosuppressant regimen at baseline, received telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.

Treatment:

Drug: Ribavirin

Drug: Pegylated Interferon Alfa-2a

Drug: Telaprevir

Drug: Immunosuppressant Regimen

T/PR + Immunosuppressant Regimen (Cyclosporine)

Experimental group

Description:

Participants who were receiving cyclosporine (CsA) based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.

Treatment:

Drug: Ribavirin

Drug: Pegylated Interferon Alfa-2a

Drug: Telaprevir

Drug: Immunosuppressant Regimen