Efficacy Study of Sequential Therapy of Peginterferon Alfa-2a Following Entecavir in Patient With Chronic Hepatitis B.

Phase 3UnknownNCT01220596

Hanyang University228 enrolled

Overview

Evaluate the safety and efficacy of Peginterferon alfa-2a following Entecavir compared with Peginterferon alfa-2a monotherapy in patient with HBeAg positive chronic hepatitis B. * Increased HBeAg seroconversion rate * Increased HBsAg loss rate * To define the best treatment condition for chronic HBV hepatitis patients

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

228

Conditions

Hepatitis B, Chronic

Interventions

Entecavir and Pegylated interferon α-2a Sequential Treatment GroupDRUG

Entecavir/Baraclude(TM), 0.5mg, oral administration, once daily, for the first 12 weeks Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, from week 4 to 52 for 48 weeks

Pegylated interferon α-2a Monotreatment GroupDRUG

Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic hepatitis B patients with HBeAg positive, HBsAg positive, HBV DNA \> 100,000 copies/ml and anti-HBs negative, serum ALT exceeding 2 X ULN but less than 10 X ULN. Exclusion Criteria: * Patient infected concurrently with HCV, HDV and HIV or patient with a history of antiviral treatment for Hepatitis B or patient with hepatic decompensation.

Locations (20)

Dong-A University Medical Center

Busan, Busan, South Korea