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3E Extension Study (3E Ex)

Primary Purpose

Chronic Hepatitis B

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Experienced Treatment

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who completed the EXPLORE or EXCEL studies, or subjects with hepatitis flare after treatment withdrawal in EFFORT study.
  • Subjects who are willing to participate the extension study.

Exclusion Criteria:

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

Sites / Locations

  • 302 Military Hospital Of China
  • Beijing Ditan Hospita
  • Beijing Friendship Hospital Attached To The Capital Medical University
  • BeiJing YouAn Hospital ,Capital Medical University
  • Department of infectious disease, First Hospital of Peking University
  • People's Hospital Under Beijnig University
  • The Second Affiliated of ChongQing University of Medical Science
  • The First Affiliated Hospital of Fujian Medical University
  • The First People's Hospital of Foshan
  • Department of Infectious Disease, Nanfang Hospital
  • GuangDong Provincial People's hospital
  • No. 8 People's Hospital In GuangZhou
  • The Third Hospital of Sun Yat-Sen University
  • First Affiliated Hospital of Guangxi Medical University
  • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
  • Xiangya Hospital Central-South Univrsity
  • No.81 Hospital of PLA
  • First Hospital .Jilin Unniversity
  • ShengJing Hospital of China Medical University
  • JiNan Infectious Diseases Hospital
  • Changhai Hospital affiliated to Second Military Medical University
  • Huashan Hospital，Fudan University
  • No.85 Hospital of PLA
  • Shanghai Ruijin Hospital
  • Tangdu Hospital
  • West China Hospital.SiChuan University
  • HangZhou No.6 People Hospital
  • The First Affiliated Hospital of College of Medicine, Zhejiang University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment group

Arm Description

Outcomes

Primary Outcome Measures

Percentages of patients achieving HBV DNA< 300copies/mL at week 144

Secondary Outcome Measures

Percentages of patients achieving HBV DNA <300copies/mL at week 48/96
The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.
Percentage of patients with ALT normalization at week 48/96/144

Full Information

First Posted
April 14, 2013
Last Updated
June 17, 2014
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Major Science and Technology Special Project of China 12th Five-year
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1. Study Identification

Unique Protocol Identification Number
NCT01834508
Brief Title
3E Extension Study
Acronym
3E Ex
Official Title
A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Plus Adefovir Combination Treatment for Patients Previously Treated in EXPLORE, EXCEL and EFFORT Ex Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Major Science and Technology Special Project of China 12th Five-year

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
Keywords
Experienced Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
Primary Outcome Measure Information:
Title
Percentages of patients achieving HBV DNA< 300copies/mL at week 144
Time Frame
Week 144
Secondary Outcome Measure Information:
Title
Percentages of patients achieving HBV DNA <300copies/mL at week 48/96
Time Frame
Week 48 & 96
Title
The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144
Time Frame
Week 48 & 96 &144
Title
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.
Time Frame
Week 48 & 96 & 144
Title
Percentage of patients with ALT normalization at week 48/96/144
Time Frame
Week 48 & 96 & 144

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who completed the EXPLORE or EXCEL studies, or subjects with hepatitis flare after treatment withdrawal in EFFORT study. Subjects who are willing to participate the extension study. Exclusion Criteria: Subjects who could not compliance with the protocol judged by investigators
Facility Information:
Facility Name
302 Military Hospital Of China
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Ditan Hospita
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Friendship Hospital Attached To The Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
BeiJing YouAn Hospital ,Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Department of infectious disease, First Hospital of Peking University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
People's Hospital Under Beijnig University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The Second Affiliated of ChongQing University of Medical Science
City
Chongqing
State/Province
Chongqing
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University
City
FuZhou
State/Province
Fujian
Country
China
Facility Name
The First People's Hospital of Foshan
City
FoShan
State/Province
Guangdong
Country
China
Facility Name
Department of Infectious Disease, Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
GuangDong Provincial People's hospital
City
GuangZhou
State/Province
Guangdong
Country
China
Facility Name
No. 8 People's Hospital In GuangZhou
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
The Third Hospital of Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
Country
China
Facility Name
First Affiliated Hospital of Guangxi Medical University
City
NanNing
State/Province
Guangxi
Country
China
Facility Name
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Xiangya Hospital Central-South Univrsity
City
Changsha
State/Province
Hunan
Country
China
Facility Name
No.81 Hospital of PLA
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
First Hospital .Jilin Unniversity
City
Changchun
State/Province
Jilin
Country
China
Facility Name
ShengJing Hospital of China Medical University
City
Shengyang
State/Province
Liaoning
Country
China
Facility Name
JiNan Infectious Diseases Hospital
City
Jinan
State/Province
Shandong
Country
China
Facility Name
Changhai Hospital affiliated to Second Military Medical University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Huashan Hospital，Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
No.85 Hospital of PLA
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tangdu Hospital
City
XiAn
State/Province
Shanxi
Country
China
Facility Name
West China Hospital.SiChuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
HangZhou No.6 People Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China

12. IPD Sharing Statement

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3E Extension Study

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