This is an open-label, randomized, safety, tolerability, dose-finding, PK/PD, and preliminary efficacy study of subcutaneous Hanferon™ in combination with ribavirin(RBV) in treatment-naïve subjects with genotype 1 hepatitis C.
The primary objective of this study is to evaluate the safety and tolerability of ascending doses of Hanferon™ in combination with ribavirin (RBV). The secondary objective of this study is to define the PK and PD of ascending doses of Hanferon™ in combination with ribavirin(RBV). The exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy in combination with ribavirin(RBV).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
SC, Weekly
SC Weekly
Oral administration (The daily dose of ribavirin(RBV) was 1000mg for subjects weighing \< 75 kg or 1200 mg for subjects weighing ≥ 75 kg)
Unnamed facility
Los Angeles, California, United States
Unnamed facility
National City, California, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Atlanta, Georgia, United States
HCV RNA level
Time frame: Week 4
Proportion of patients who reach RVR
Time frame: Week 4
PK & PD
Time frame: Weeks 0 and 3
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Unnamed facility
Lexington, Kentucky, United States
Unnamed facility
New Orleans, Louisiana, United States