Efficacy Study of Sequential Therapy of Peginterferon Alfa-2a Following Entecavir 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 Entercavir Compared With Peginterferon Alfa-2a Monotherapy in Patient With HBeAg Positive Chronic Hepatitis B.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01220596

Acronym

POTENT

Enrollment

228

Registered

2010-10-14

Start date

2010-06-30

Completion date

2013-06-30

Last updated

2011-07-04

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

Conditions

Hepatitis B, Chronic

Brief summary

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

Interventions

DRUGEntecavir and Pegylated interferon α-2a Sequential Treatment Group

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

DRUGPegylated interferon α-2a Monotreatment Group

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
HBeAg seroconversion	24 weeks after treatment

Secondary

Measure	Time frame
the change of HBsAg titer	24 weeks after treatment
the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml	24 weeks after treatment
The rate of serum HBV DNA < 300 copies	24 weeks after treatment
The rate of ALT normalization	24 weeks after treatment
The rate of HBsAg loss	24 weeks after treatment

Countries

South Korea

Contacts

Primary ContactJoo Hyun Sohn, MD, Ph.D

sonjh@hanyang.ac.kr+82-31-560-2225

Backup ContactDae-Won Jun, MD, Ph.D

noshin@hanyang.ac.kr+82-2-2290-8338

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026