1. To characterize the tolerability profile of subcutaneous (SC) CPG 10101 alone, with pegylated interferon, ribavirin or both pegylated interferon and ribavirin when administered weekly for twelve weeks in relapsed HCV positive subjects. 2. To assess the effect of subcutaneous (SC) CPG 10101 alone, with pegylated interferon, ribavirin or both pegylated interferon and ribavirin on serum Hepatitis C Virus (HCV) RNA concentrations
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
91
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Chicago, Illinois, United States
Pfizer Investigational Site
Indianapolis, Indiana, United States
Adverse events, vital signs, clinical and laboratory parameters, physical exam, ECG
Time frame: 16wks
Serum HCV RNA concentrations: Serum HCV concentrations over time to baseline
Time frame: 12wks
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CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks
Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks
CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks
Pfizer Investigational Site
Detroit, Michigan, United States
Pfizer Investigational Site
Kansas City, Missouri, United States
Pfizer Investigational Site
New York, New York, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Hershey, Pennsylvania, United States
Pfizer Investigational Site
Charleston, South Carolina, United States
Pfizer Investigational Site
Jackson, Tennessee, United States
...and 3 more locations