Peginterferon Dose Evaluations for Previously Untreated Subjects With Chronic Hepatitis C Infected With Genotype 1 (Study P03471)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: PegIntron (peginterferon alfa-2b; SCH 54031); PegIntron (peginterferon alfa-2b; SCH 54031); REBETOL (ribavirin; SCH 18908); PEGASYS (peginterferon alfa-2a); COPEGUS (ribavirin)
Intervention description: 1.5 ug/kg/week subcutaneously (SC) for 48 weeks; 1.0 ug/kg/week SC for 48 weeks; weight based dose 800-1400 mg/day orally (PO) for 48 weeks; 180 ug/week SC administered for 48 weeks; 1000-1200 mg/day PO for 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha; Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4469.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The objective is to compare the safety and efficacy of the following three treatment regimens
      in previously untreated adult subjects with chronic hepatitis C infected with Genotype 1: (1)
      PegIntron 1.5 µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); (2)
      PegIntron 1µg/kg/wk in combination with weight based REBETOL (800-1400 mg/day); and (3)
      PEGASYS 180 µg/wk plus COPEGUS 1000-1200 mg/day.
    

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