PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)

An Open-label, Randomized Study of PegIntron in the Treatment of HBeAg Positive Chronic Hepatitis B Patients

The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0 microgram (mcg)/kg given once a week for 24 weeks. This study compares dosages of (1) 1.5 mcg/kg once a week for 24 weeks and (2) 1.5 mcg/kg once a week for 48 weeks with the approved dosage. All subjects are followed for 24 weeks after their treatment ends.

Inclusion Criteria:

• Adults with chronic hepatitis B:

  • Serum hepatitis B surface antigen positive for at least 6 months
  • Serum hepatitis B e antigen positive
  • Serum negative for hepatitis B surface and e antibodies
  • Plasma hepatitis B virus deoxyribonucleic acid (DNA) level greater than 20,000 IU/mL
  • Alanine aminotransferase (ALT) 2- to 10-times the upper limit of normal

• Compensated liver disease with certain minimum hematological and serum biochemical criteria

Exclusion Criteria:

• Significant hepatic disease from an etiology other than hepatitis B virus
• Antiviral treatment for hepatitis within previous 6 months
• History of severe psychiatric disease, especially depression
• Unstable or significant cardiovascular disease
• Prolonged exposure to known hepatotoxins such as alcohol or drugs
• Any condition that could interfere with the subject participating in and completing the study