Clareo Health | An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Vertex Pharmaceuticals Incorporated
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
