The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in
combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV)
(T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC
genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV)
infection and will not have cirrhosis of the liver.
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Inclusion Criteria:
- Male and female subjects, 18 to 70 years of age, inclusive
- Treatment-naive OR subjects (prior relapsers) may be included who did not achieve
sustained viral response 24 weeks after last planned dose of study drug (SVR24) after
at least 1 prior course of Peg-IFN/RBV therapy of standard duration and had a
documented undetectable HCV RNA level at the planned end of treatment of at least
42-week duration
- Subjects have IL28B CC genotype determined during screening
- Subjects have genotype 1 chronic hepatitis C and laboratory evidence of HCV infection
for at least 6 months, defined by (1) documented HCV serology test at least 6 months
before the first screening visit demonstrating the presence of anti-HCV antibody, or
(2) documented presence of HCV RNA by a sensitive and specific assay at least 6
months before the first screening visit, or (3) documented histologic evidence of
chronic hepatitis C demonstrated by fibrosis on a standardized histologic grading
system at least 6 months before the first screening visit. If only inflammation is
present in the liver histologic report, then 6 months of laboratory evidence is
required
Exclusion Criteria:
- Subjects have received previous treatment with telaprevir or any other protease
inhibitor(s) for chronic hepatitis C
- Subjects who did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV
therapy of standard duration and never achieved undetectable HCV RNA while on
treatment
- Subjects have evidence of hepatic decompensation
- Subjects have evidence of cirrhosis
- Subjects have diagnosed or suspected hepatocellular carcinoma
- Subjects have any other cause of significant liver disease in addition to hepatitis
C, which may include but is not limited to malignancy with hepatic involvement,
hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis,
hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary
cirrhosis. Steatosis is allowed if clinically asymptomatic
Linz 4010, Austria
Vienna 1090, Austria
Vienna 1160, Austria
Berlin 10969, Germany
Dusseldorf 40237, Germany
Frankfurt 60590, Germany
Hamburg 20099, Germany
Hannover 30625, Germany
Koeln 50937, Germany
Leipzig 4103, Germany
Munich 81377, Germany
Haifa 31096, Israel
Haifa 34362, Israel
Israel, Jerusalem 91120, Israel
Nazareth 16100, Israel
Petah Tikva 49100, Israel
Tel Hashomer 52621, Israel
Bialystok 16-540, Poland
Czeladz 41-250, Poland
Myslowice 41-400, Poland
Wroclaw 50-220, Poland
Birmingham, Alabama 35209, United States
Birmingham, Alabama 35294, United States
Calgary, Alberta T2N 4Z6, Canada
Edmonton, Alberta T5M 1J7, Canada
Edmonton, Alberta T6G 2X8, Canada
Phoenix, Arizona 85054, United States
Vancouver, British Columbia V6T 1Z3, Canada
La Jolla, California 93037, United States
Los Angeles, California 90027, United States
California, Los Angeles, California 90048, United States
Sacramento, California 95817, United States
San Diego, California 92103, United States
San Diego, California 92105, United States
San Diego, California 92154, United States
California, San Francisco, California 94115, United States
Farmington, Connecticut 06030, United States
New Haven, Connecticut 06511, United States
Bradenton, Florida 34209, United States
Gainesville, Florida 32224, United States
Jacksonville, Florida 32224, United States
Jacksonville, Florida 32256, United States
Orlando, Florida 32803, United States
Atlanta, Georgia 30308, United States
Marietta, Georgia 30060, United States
Honolulu, Hawaii 96817, United States
Chicago, Illinois 60612, United States
Chicago, Illinois 60611, United States
Winnipeg, Manitoba R3E 3P4, Canada
Baltimore, Maryland 21202, United States
Baltimore, Maryland 21287, United States
Columbia, Maryland 21045, United States
Boston, Massachusetts 02215, United States
Brockton, Massachusetts 02302, United States
Burlington, Massachusetts 01805, United States
Worcester, Massachusetts 01605, United States
Novi, Michigan 48202, United States
Kansas City, Missouri 64131, United States
Lebanon, New Hampshire 03756, United States
Egg Harbor Township, New Jersey 08234, United States
Vineland, New Jersey 08360, United States
Flushing, New York 11355, United States
Manhasset, New York 10030, United States
New York, New York 10003, United States
New York, New York 10021, United States
New York, New York 10029, United States
Chapel Hill, North Carolina 27599, United States
Charlotte, North Carolina 28203, United States
Durham, North Carolina 27710, United States
Toronto, Ontario M5G 2N2, Canada
Toronto, Ontario M5T 2S8, Canada
Pennsylvania, Hershey, Pennsylvania 17033, United States
Arlington, Texas 76012, United States
Houston, Texas 77030, United States
San Antonio, Texas 78215, United States
Virginia, Fairfax, Virginia 22031, United States
Falls Church, Virginia 22042, United States
Norfolk, Virginia 23502, United States
Richmond, Virginia 23249, United States
Seattle, Washington 98101, United States
Madison, Wisconsin 53715, United States
Madison, Wisconsin 53792, United States
Milwaukee, Wisconsin 53226, United States