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

TERMINATEDPHASE2

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

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

NCT01467505•Vertex Pharmaceuticals Incorporated

View on ClinicalTrials.gov

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 transplantation.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 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 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
+5 more criteria

Locations (22)

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

Key Dates

Start Date

February 1, 2012

Primary Completion Date

April 1, 2014

Completion Date

April 1, 2014

Last Updated

June 18, 2015

Enrollment

ACTUAL participants

Conditions

Hepatitis C

Interventions

Telaprevir

DRUG

Ribavirin

DRUG

Pegylated Interferon Alfa-2a

DRUG

Immunosuppressant Regimen

DRUG

Implementing Low-Barrier HCV Treatment in a Jail Setting

NCT06953479

HEPATITIS C (HCV)Incarceration+2 more

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RECRUITINGNA

Project I Test: Implementing HIV Testing in Opioid Treatment Programs

NCT03135886

HIV/AIDSHepatitis C+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 18, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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