Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538 Part 1)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: peginterferon alfa-2b (PEG2b) (SCH 54031); ribavirin (SCH 18908)
Intervention description: PEG2b 1.5 μg/kg/wk given subcutaneously (once weekly) for 48 weeks.; 15 mg/kg/day for up to 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b; Interferon-alpha
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 107.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The primary objective is to assess the safety, efficacy and tolerability of the combination
      of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C. The secondary
      objective is to measure the multiple-dose pharmacokinetics of PEG-Intron and REBETOL in
      pediatric subjects with chronic hepatitis C.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children age 3-17 years old

          -  Individuals weighing ≤ 90 kg

          -  Previously untreated children with chronic hepatitis C (HCV RNA qPCR plasma positive)

          -  Individuals with any HCV (hepatitis C virus) genotype

          -  Hematology laboratory results of:

               -  Hemoglobin (HGB) ≥ 11 g/dL for females or ≥ 12g/dL for males,

               -  White Blood Cell Count (WBC) ≥ 3,000/mm^3,

               -  Neutrophils ≥ 1,500/mm^3,

               -  Platelets ≥ 100,000/mm^3

          -  Chemistry laboratory results of:

               -  Normal Thyroid Stimulating Hormone (TSH), albumin, creatinine, and Bilirubin,

               -  Antinuclear antibody (ANA) ≤ 1:160,

               -  Fasting Glucose 70-140 mg/dL. Note: If glucose levels are between 116-140 mg/dL
                  or an individual has diabetes, HbA1C must be ≤ 8.5%

          -  Compensated liver disease

          -  Historic or pre-treatment liver biopsy slides available

          -  No significant co-existing psychiatric disease

          -  Those with diabetes, hypertension, or birth prior to 32 weeks gestational age must
             have normal eye exams and retinal photographs (these will be done as part of the study
             before hepatitis C treatment is given)

          -  Patients and partners of patients willing to use adequate contraception during the
             course of the study

          -  Abstain from alcohol and any other illicit drugs

        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