Efficacy of Peg-interferon α-2a in Hepatitis B Patients Treated by Entecavir Without HBeAg Loss

The Efficacy of Peg-interferon α-2a in HBeAg (+) Chronic Hepatitis B Patients Who Have Been Treated by Entecavir for 48 Weeks But Without HBeAg Loss

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01599130

Enrollment

Registered

2012-05-15

Start date

2012-07-31

Completion date

2014-04-30

Last updated

2012-05-15

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

Conditions

Hepatitis B

Keywords

Hepatitis B, sequential peg-interferon-2a to entecavir

Brief summary

For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In the investigators study, patients were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

Detailed description

For HBeAg positive hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In our study, patients without HBeAg loss to 48 weeks entecavir treatment were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

Interventions

DRUGEntecavir

entecavir 0.5mg per day

DRUGPeginterferon alfa-2a

Peginterferon alfa-2a 180ug per week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Age between 18 and 50 years old * HBsAg(+) and HBeAg(+) for over 6 months before entecavir treatment * Treated by entacavir for 48 weeks with HBeAg seroconversion

Exclusion criteria

* Pregnant women * Decompensated liver disease * Combination infection of HCV, HAV, or HEV * Combination infection of HIV * Any contraindication of interferon α

Design outcomes

Primary

Measure	Time frame
HBeAg sericonversion rate	72 weeks

Secondary

Measure	Time frame
HBeAg quantification dynamic change	72 weeks
HBsAg loss rate	72 weeks
HBeAg loss rate	72 weeks
HBsAg quantification dynamic change	72 weeks
ALT normalization rate	72 weeks
HBsAg seroconversion rate	72 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026