Treatment, Randomized, Double-Blind, Placebo Controlled, Safety/Efficacy Study
Inclusion Criteria:
Male or female patients who are at least 5 years up to 18 years of age
HCV (Hepatitis C virus) RNA positive present on 2 tests separated by at least 6 months
Chronic liver disease, consistent with chronic hepatitis C infection diagnosed on a liver biopsy obtained within the past 24 months
Signed informed consent/assent from the legal guardian/patient and willingness of the legal guardian/patient to follow the requirements of the study
Able to swallow a pill the size of a "tic tac"
Exclusion Criteria:
Any prior treatment with Interferon or Ribavirin
Treatment with any investigational drug less than 6 weeks prior to the first dose of study drug
Positive test at study entry for active Hepatitis A, Hepatitis B, or HIV
A medical condition associated with chronic liver disease other than HCV
Severe liver disease such as yellow jaundice or bleeding from varices
Autoimmune disease
Major depression
Chronic pulmonary or cardiac disease
Thyroid disease poorly controlled on prescribed medications.
Poorly controlled diabetes
Solid organ or bone marrow transplantation
Severe retinopathy
Bleeding disorder
Active or suspected cancer
Severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
Sexually active females of child-bearing potential (defined as age 10 years and older) and sexually active males who are not practicing two forms of effective contraception during treatment and during the 6 months after treatment has been concluded
Females who are pregnant or males whose female partners are pregnant
Active substance abuse
A sibling and/or any other child living in the same household, or sharing the same primary caregiver, enrolled in the study.
