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

Stopped early · Phase 2

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT01467505

Run by

Vertex Pharmaceuticals Incorporated

People needed

61

Starts

2012-02-01

Expected to finish

2014-04-01

Last updated by the study team

2015-06-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• Alabama — Birmingham, Alabama, United States
• Arizona — Phoenix, Arizona, United States
• California — Los Angeles, California, United States
• Colorado — Denver, Colorado, United States
• Florida — Bradenton, Florida, United States
• Florida — Miami, Florida, United States
• Illinios — Evanston, Illinois, United States
• Indiana — Indianapolis, Indiana, United States
• Massachusetts — Burlington, Massachusetts, United States
• Michigan — Ann Arbor, Michigan, United States
• Michigan — Detroit, Michigan, United States
• Missouri — St Louis, Missouri, United States
• Nebraska — Omaha, Nebraska, United States
• New York — New York, New York, United States
• New York — Rochester, New York, United States
• North Carolina — Charlotte, North Carolina, United States
• Ohio — Cleveland, Ohio, United States
• Pennsylvania — Philadelphia, Pennsylvania, United States
• Texas — Dallas, Texas, United States
• Texas — Houston, Texas, United States
• Study site — Calgary, Alberta, Canada
• Study site — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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