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



Status:Recruiting
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:February 2012
Contact:Central Contact Center
Email:medicalinfo@vrtx.com

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A 2-Part, Open Label Study of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Chronically Infected With Genotype 1 Hepatitis C Virus Following Liver Transplantation


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


Inclusion Criteria:

- Male and female subjects 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 P/R treatment or experienced with P/R 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 > 1 rejection
within 12 months

- Current treatment with sirolimus or methylprednisolone. Low dose prednisone use (<5
mg/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 HIV1/2 EIA antibody screen or Hepatitis B 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 HCV protease inhibitor
We found this trial at
16
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Phoenix, Arizona
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Birmingham, Alabama
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