An Open Label Study of the Effect of Telaprevir in Combination With Ribavirin and Peginterferon on HCV Infection in Stable Liver Transplant Patients
NCT ID: NCT01467505
Last Updated: 2015-06-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
61 participants
INTERVENTIONAL
2012-02-29
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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T/PR + Immunosuppressant Regimen (Tacrolimus)
Participants who were receiving tacrolimus (TAC) based immunosuppressant regimen at baseline, received telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
Telaprevir
Tablet
Ribavirin
Tablet
Pegylated Interferon Alfa-2a
Subcutaneous Injection
Immunosuppressant Regimen
Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice. Immunosuppressant regimen were not considered study drugs.
T/PR + Immunosuppressant Regimen (Cyclosporine)
Participants who were receiving cyclosporine (CsA) based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
Telaprevir
Tablet
Ribavirin
Tablet
Pegylated Interferon Alfa-2a
Subcutaneous Injection
Immunosuppressant Regimen
Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice. Immunosuppressant regimen were not considered study drugs.
Interventions
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Telaprevir
Tablet
Ribavirin
Tablet
Pegylated Interferon Alfa-2a
Subcutaneous Injection
Immunosuppressant Regimen
Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice. Immunosuppressant regimen were not considered study drugs.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Vertex Pharmaceuticals Incorporated
Locations
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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
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
Countries
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Other Identifiers
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VX11-950-117
Identifier Type: -
Identifier Source: org_study_id
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