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

Hanyang University

Status and phase

Unknown

Phase 3

Conditions

Hepatitis B, Chronic

Treatments

Drug: Pegylated interferon α-2a Monotreatment Group

Drug: Entecavir and Pegylated interferon α-2a Sequential Treatment Group

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01220596

ML25206

Details and patient eligibility

About

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

Enrollment

228 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

228 participants in 2 patient groups

Sequential therapy

Experimental group

Description:

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

Treatment:

Drug: Entecavir and Pegylated interferon α-2a Sequential Treatment Group

Peginterferon alfa-2a monotherapy

Active Comparator group

Description:

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

Treatment:

Drug: Pegylated interferon α-2a Monotreatment Group