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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

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

Criteria

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