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



Status:Recruiting
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:February 2012
Contact:Central Contact Center
Email:medicalinfo@vrtx.com

Use our guide to learn which trials are right for you!

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


To assess efficacy of telaprevir, peginterferon alfa-2a (Peg-IFN), and ribavirin (RBV) for
HCV in a 48-week total treatment duration regimen following liver transplantation.


Inclusion Criteria:

- Male and female subjects 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 P/R treatment or experienced with P/R 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 > 1 rejection
within 12 months

- Current treatment with sirolimus or methylprednisolone. Low dose prednisone use (<5
mg/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 HIV1/2 EIA antibody screen or Hepatitis B 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 HCV protease inhibitor
We found this trial at
16
sites
Evanston, Illinois
1728
mi
from 91732
Evanston, IL
Click here to add this to my saved trials
Birmingham, Alabama
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
Boston, Massachusetts
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
Chapel Hill, North Carolina
2194
mi
from 91732
Chapel Hill, NC
Click here to add this to my saved trials
Cincinnati, Ohio
1880
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
Coronado, California
108
mi
from 91732
Coronado, CA
Click here to add this to my saved trials
Denver, Colorado
817
mi
from 91732
Denver, CO
Click here to add this to my saved trials
Gainesville, Florida
2105
mi
from 91732
Gainesville, FL
Click here to add this to my saved trials
Houston, Texas
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
Indianapolis, Indiana
1792
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
Manhasset, New York
2448
mi
from 91732
Manhasset, NY
Click here to add this to my saved trials
Novi, Michigan
1945
mi
from 91732
Novi, MI
Click here to add this to my saved trials
Omaha, Nebraska
1299
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
Philadelphia, Pennsylvania
2374
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona
341
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
St Louis, Missouri
1573
mi
from 91732
St Louis, MO
Click here to add this to my saved trials