Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C
Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C
The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon
 alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a
 safe and effective treatment for patients with chronic hepatitis C infection as compared to
 patients who receive standard treatment.
The study will include patients who are diagnosed with chronic hepatitis C genotype 1
 infection and who have received no previous interferon or other anti-HCV treatment.
Inclusion Criteria:

 -  Signed patient consent form

 -  Genotype 1 chronic HCV with detectable HCV RNA

 -  No previous treatment for HCV infection

 -  Hepatitis B and human immunodeficiency virus negative at screening visit

 -  Able and willing to follow contraception requirements

 -  Screening laboratory values, test, and physical exam within acceptable ranges

 -  Weight between 40 kg and 125 kg

 -  Proficiency in the use of the external pump infusion system

 Exclusion Criteria:

 -  Current or planned enrollment in another investigational device or drug study

 -  Anticipated inability to complete all clinic visits and comply with study procedures

 -  History of, or any current medical condition, which could impact the safety of the
 subject during the study

 -  Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease,
 or other known liver disease other than HCV

 -  Alcoholism or substance abuse with <6 documented months of sobriety

 -  Known allergy or sensitivity to interferons or ribavirin

 -  Any other condition that, in the opinion of the Investigator, would make the subject
 unsuitable for enrollment or could interfere with the subject participating in and
 completing the study