Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538 Part 1)

Exclusion Criteria

• •Serum ALT \>10 times the upper limit of normal within the 6 months prior to study
• •Previous hepatitis C treatment
• •Children with liver disease not caused by hepatitis C
• •Most recent liver biopsy is normal
• •Individuals infected with the hepatitis B virus and/or human immunodeficiency virus (HIV)
• •Known blood disorders such as hemoglobinopathy, coagulopathy, or G6PD deficiency
• •Known immunodeficiency disorders requiring immunoglobulin therapy
• •Body organ transplant
• •Any known or suspected cancer within the past 5 years
• •Children with chronic pulmonary disease
• •Individuals who have a medical condition that would likely require systemic steroids
• •Those with a history of central nervous system (CNS) trauma or seizure disorders
• •Individuals with pre-existing psychiatric disorders including but not limited to moderate to severe depression
• •Current or previous use of lithium or antipsychotic drugs
• •Patients with clinically significant electrocardiogram (ECG) abnormalities and/or significant cardiovascular dysfunction (e.g., angina, congestive heart failure, recent myocardial infarction, uncontrolled hypertension, significant arrhythmia, cardiac sequelae from Kawasaki disease, cardiomyopathy, and/or history of congenital heart disease)
• •Insulin-dependent diabetes mellitus or poorly controlled non-insulin dependent diabetes mellitus
• •Immunologically mediated disease (e.g., inflammatory bowel disease \[Crohn's disease, ulcerative colitis\], rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, or symptomatic thyroid disorder)
• •History of substance abuse, including alcohol (e.g., binge drinking, blackouts), intravenous drugs and inhaled drugs
• •Subjects who have a history of pregnancy or who are pregnant and/or breast feeding. Subjects who intend to become pregnant during the study period. Subjects with partners who intend to become pregnant during the study period
• •Subjects with clinically significant retinal abnormalities such as known retinopathy of prematurity or other retinopathies