Study on Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients will receive Peginterferon alfa-2a according to the standard medical practice but the observation period is 12 weeks

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Collaborator: Roche Pharma AG
• Treatments: Interferon-alpha; Interferons; Peginterferon alfa-2a

Criteria

Inclusion Criteria:

• History of HBsAg positive for more than 6 months

• HBeAg-positive or HBeAg-negative within 8 weeks

• Serum AST or ALT ≥ 80 IU/L

• HBe-Ag positive patients: Serum HBV DNA ≥ 1.0 X 10^5 copies/mL (or 20,000 IU/mL)

• HBeAg-negative patients: serum HBV DNA ≥ 1.0 X 10^4 copies/mL(or 2,000 IU/mL)

Exclusion Criteria:

• History of antiviral therapy for Chronic hepatitis B within 6 months of study enrollment

• Prior treatment of interferon

• Presence of viral coinfections (hepatitis C, hepatitis delta, or human immunodeficiency virus)

• Other chronic liver disease or decompensated liver disease

• platelet<90,000/mm3 or absolute neutrophil count < 1,500 mm3

• Pregnant or lactating woman

• History of Organ transplantation

• Treatment with immunosuppressive/immunomodulatory agents within 6 months prior to study entry