Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)
Hepatitis C, Chronic

About this trial
This is an interventional treatment trial for Hepatitis C, Chronic
Eligibility Criteria
INCLUSION CRITERIA: Previously untreated adults with chronic hepatitis C (hepatitis C virus ribonucleic acid [HCV RNA] quantitative polymerase chain reaction [qPCR] plasma positive) Individuals with HCV genotype 1 (mixed 1a/1b is acceptable) Compensated liver disease Pretreatment liver biopsy slides available Adults aged 18-70 Individuals weighing 88-275 pounds (40-125 kg) Free from substance abuse for past 2 years Those suffering from diabetes and/or hypertension 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 Hematology laboratory results of: Hemoglobin (HGB) ≥ 12 g/dL for females or ≥ 13g/dL for males White Blood Cell Count (WBC) ≥ 3,000/mm^3 Neutrophils ≥ 1,500/mm^3 Platelets ≥ 80,000/mm^3 Chemistry laboratory results of: Normal Thyroid Stimulating Hormone (TSH), albumin, creatinine, and direct bilirubin Antinuclear antibody (ANA) ≤ 1:320 Fasting Glucose 70-140 mg/dL Note: If glucose levels are between 116-140 mg/dL or an individual has diabetes, glycosylated hemoglobin [HbA1C] must be ≤ 8.5% EXCLUSION CRITERIA: Previous hepatitis C treatment Pregnant women or partners of pregnant women Patients or partners of patients who intend to become pregnant any time during the 48 weeks Women who are breastfeeding Individuals with liver disease not caused by hepatitis C Individuals infected with the hepatitis B virus and/or human immunodeficiency virus (HIV) Patients with a history of liver cancer (hepatocellular carcinoma) Known blood disorders such as hemoglobinopathy, coagulopathy, or glucose-6-phosphate dehydrogenase [G6PD] deficiency Body organ transplant Any known or suspected cancer within the past 5 years Individuals who currently use epoetin [EPO], granulocyte colony stimulating factor [G-CSF] and/or granulocyte monocyte colony stimulating factor [GM-CSF] Those having a history of or active clinical gout Individuals who have 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 Current or previous use of lithium or antipsychotic drugs Individuals who currently have or show signs of moderate to severe depression or history of significant psychiatric disorders Patients with clinically significant electrocardiogram (ECG) abnormalities Individuals with serious heart problems such as those who have had a heart attack, uncontrolled high blood pressure, or other heart problems Patients that weigh > 231-275 pounds (105-125 kg) AND have a body mass index (BMI) > 30 AND have 3 or more of the risk factors below: (a) Strong family history of coronary heart disease (CHD) which includes 2 or more first-degree relatives with CHD or family history of early CHD at age < 55 for male relatives or < 65 for female relatives (b) Individuals with abnormal total cholesterol and/or sub fractions (uncontrolled hypercholesterolemia) (c) Diabetes (d) Hypertension (e) Smoking
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Active Comparator
PegIntron 1.5 ug/kg/wk plus REBETOL
PegIntron 1.0 ug/kg/wk plus REBETOL
PEGASYS 180 ug/wk Plus COPEGUS
PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up