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 |
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
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