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

Yonsei University

Status and phase: Unknown; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: Peginterferon alfa-2a

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02822547

ML29378

Details and patient eligibility

About

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

Enrollment: 253 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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253 participants in 1 patient group

Peginterferon alfa-2a

Experimental group

Treatment:

Drug: Peginterferon alfa-2a