Efficacy study of sequential therapy of Peginterferon alfa-2a (Pegasys(TM)) following Entecavir compared with Peginterferon alfa-2a monotherapy in patient with chronic hepatitis B

A randomized, multi center, phase IIIb open-label study to evaluate the efficacy of sequential therapy of Peginterferon alfa-2a(Pegasys(TM)) following Entecavir compared with Peginterferon alfa-2a monotherapy in patient with HBeAg positive chronic hepatitis B

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CRIS

Registry ID

KCT0000042

Enrollment

228

Registered

2010-10-08

Start date

2010-06-10

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Generic/Brand name: Pegylated interferon a-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for 48 weeks Generic/Brand name: Entecavir/Baraclude(TM), 0.5mg, oral administration, onc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Chronic hepatitis B patients with HBeAg positive, HBsAg positive, HBV DNA > 100,000 copies/ml, anti-HBs negative, serum ALT exceeding 2 X ULN but less than 10 X ULN.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
HBeAg seroconversion	—

Secondary

Measure	Time frame
the change of HBsAg titer;the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml;The rate of serum HBV DNA < 300 copie;The rate of ALT normalization;The rate of HBsAg loss	—

Countries

Korea, Republic of

Contacts

Public ContactDae-won Jun

Hanyang University Seoul Hospital

Outcome results