Status:
TERMINATED
An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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 transpla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT01467505
Start Date
February 1 2012
End Date
April 1 2014
Last Update
June 18 2015
Active Locations (22)
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1
Alabama
Birmingham, Alabama, United States
2
Arizona
Phoenix, Arizona, United States
3
California
Los Angeles, California, United States
4
Colorado
Denver, Colorado, United States