Efficacy Optimizing Extension Study of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy (Dragon-Ex)

June 17, 2014 updated by: Nanfang Hospital of Southern Medical University

A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Therapy for Patients Previously Treated in Dragon Study

The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 4

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
    • Beijing
      • Beijing, Beijing, China
        • Beijing Ditan Hospital
      • Beijing, Beijing, China
        • Beijing Friendship Hospital Attached to the Capital Medical University
      • Beijing, Beijing, China
        • Department of infectious disease, First Hospital of Peking University
      • Beijing, Beijing, China
        • People'S Hospital Under Beijnig University
    • Fujian
      • FuZhou, Fujian, China
        • The First Affiliated Hospital of Fujian Medical University
    • Guangdong
      • FoShan, Guangdong, China
        • The First People's Hospital of Foshan
      • GuangZhou, Guangdong, China
        • Guangdong Provincial People's Hospital
      • Guangzhou, Guangdong, China
        • Department of Infectious Disease, Nanfang Hospital
    • Guangxi
      • NanNing, Guangxi, China
        • First Affiliated Hospital of Guangxi Medical University
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
    • Hunan
      • Changsha, Hunan, China
        • Xiangya Hospital Central-South Univrsity
    • Jilin
      • Changchun, Jilin, China
        • First Hospital .Jilin Unniversity
    • Liaoning
      • Shengyang, Liaoning, China
        • Shengjing Hospital of China Medical University
    • Shanghai
      • Shanghai, Shanghai, China
        • Changhai Hospital Affiliated to Second Military Medical University
      • Shanghai, Shanghai, China
        • Huashan Hospital,Fudan University
      • Shanghai, Shanghai, China
        • Shanghai Ruijin Hospital

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 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects who completed the 104-week Dragon study.
  • Subjects who are willing to participate the extension study.

Exclusion Criteria:

  • Subjects who could not compliance with the protocol judged by investigators

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: Group I
oral entecavir 1mg daily and adefovir 10mg daily for 144 weeks
Drug: Entecavir, Adefovir
Active Comparator: Group II
oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
Drug: Entecavir, Adefovir

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group
Time Frame: Week 144
Week 144

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.
Time Frame: Week 48 & 96 & 144
Week 48 & 96 & 144
Percentage of patients with ALT normalization at week 48/96/144
Time Frame: Week 48 & 96 & 144
Week 48 & 96 & 144
Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group.
Time Frame: Week 48 & 96
Week 48 & 96
The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144.
Time Frame: Week 48 & 96 &144
Week 48 & 96 &144

Collaborators and Investigators

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

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

Major Science and Technology Special Project of China Eleventh Five-year

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2013

Primary Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (Estimate)

April 11, 2013

Study Record Updates

Last Update Posted (Estimate)

June 19, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOH-06

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.

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