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

Not Applicable

• Conditions: Hepatitis B
• Interventions: Drug: Entecavir; Drug: Peginterferon alfa-2a

• Registration Number: NCT01599130
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2012-05
• Study First Submitted: 2012-05-08
• Study First Submitted QC: 2012-05-14
• Last Update Submitted: 2012-05-14
• Study First Posted: 2012-05-15
• Last Update Posted: 2012-05-15
• Study Start: 2012-07
• Primary Completion: 2014-04
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
entecavir	Entecavir	patients continue to use entecavir
peg-interferon	Peginterferon alfa-2a	patients switch to sequential peg-interferon α-2a

Primary Outcome Measures

Name	Time	Method
HBeAg sericonversion rate	72 weeks

Secondary Outcome Measures

Name	Time	Method
HBeAg loss rate	72 weeks
HBeAg quantification dynamic change	72 weeks
HBsAg loss rate	72 weeks
HBsAg seroconversion rate	72 weeks
HBsAg quantification dynamic change	72 weeks
ALT normalization rate	72 weeks

Trial Locations

Locations (1)

The Third Affliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China