A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, PK/PD, and Preliminary Efficacy Study of SC Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
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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 RBV. The exploratory objective of this study is to make a preliminary assessment of Hanferon™ efficacy in combination with RBV.
Condition or disease
Chronic Hepatitis C InfectionGenotype 1
Drug: recombinant variant of interferon-alpha 2bDrug: Peginterferon alfa-2a
A Phase 1b/2a, Open-label,Randomized, Safety, Tolerability, Dose Finding, Pharmacokinetic/Pharmacodynamic, and Preliminary Efficacy Study of Subcutaneous Hanferon™ in Combination With Ribavirin in Treatment-naïve Subjects With Genotype 1 Hepatitis C
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of chronic hepatitis C genotype 1a or 1b
Male or female aged 18 to 65 years, inclusive
Compensated liver disease without evidence of cirrhosis
No evidence of type 1 or 2 diabetes mellitus, lipodystrophy or polycystic ovary syndrome
No history or presence of autoimmune or lymphoproliferative disease or hemoglobinopathies
Stable medication doses for 1 month for the chronic disease if subjects have chronic diseases, including but not limited to hypertension and dyslipidemia
History of previous treatment of hepatitis C
Currently use medication for psychiatric illness including depression, suicidal ideation, and psychosis
History or presence of chronic liver disease
History of drug or alcohol abuse within the past year
Evidence of active illicit drug use
Clinically significant abnormal electrocardiogram (ECG) or rhythm strip
Female subject who has a positive urine pregnancy test or who is lactating