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

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Peginterferon alfa-2b; Ribavirin

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