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

May 14, 2012 updated by: Gao zhiliang, Sun Yat-sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • The Third Affliated Hospital of Sun Yat-sen University
        • Contact:
        • Contact:
          • Phone Number: +862085253333
        • Principal Investigator:
          • Zhiliang Gao, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: entecavir
patients continue to use entecavir
Drug: Entecavir
entecavir 0.5mg per day
Other Names:
  • Baraclude
Experimental: peg-interferon
patients switch to sequential peg-interferon α-2a
Drug: Peginterferon alfa-2a
Peginterferon alfa-2a 180ug per week
Other Names:
  • Pagasys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HBeAg sericonversion rate
Time Frame: 72 weeks
72 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
HBeAg loss rate
Time Frame: 72 weeks
72 weeks
HBeAg quantification dynamic change
Time Frame: 72 weeks
72 weeks
HBsAg loss rate
Time Frame: 72 weeks
72 weeks
HBsAg seroconversion rate
Time Frame: 72 weeks
72 weeks
HBsAg quantification dynamic change
Time Frame: 72 weeks
72 weeks
ALT normalization rate
Time Frame: 72 weeks
72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Zhiliang Gao, The Third Affliated Hospital of Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

May 8, 2012

First Submitted That Met QC Criteria

May 14, 2012

First Posted (Estimate)

May 15, 2012

Study Record Updates

Last Update Posted (Estimate)

May 15, 2012

Last Update Submitted That Met QC Criteria

May 14, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zhangyufeng

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B

Clinical Trials on Entecavir

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Arab Emirates

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe