3E Extension Study
3E Ex
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
1 other identifier
interventional
600
1 country
28
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Mar 2013
Longer than P75 for phase_4
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 14, 2013
CompletedFirst Posted
Study publicly available on registry
April 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJune 19, 2014
June 1, 2014
3.3 years
April 14, 2013
June 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentages of patients achieving HBV DNA< 300copies/mL at week 144
Week 144
Secondary Outcomes (4)
Percentages of patients achieving HBV DNA <300copies/mL at week 48/96
Week 48 & 96
The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144
Week 48 & 96 &144
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.
Week 48 & 96 & 144
Percentage of patients with ALT normalization at week 48/96/144
Week 48 & 96 & 144
Study Arms (1)
Treatment group
OTHERInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Subjects who could not compliance with the protocol judged by investigators
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
302 Military Hospital Of China
Beijing, Beijing Municipality, China
Beijing Ditan Hospita
Beijing, Beijing Municipality, China
Beijing Friendship Hospital Attached To The Capital Medical University
Beijing, Beijing Municipality, China
BeiJing YouAn Hospital ,Capital Medical University
Beijing, Beijing Municipality, China
Department of infectious disease, First Hospital of Peking University
Beijing, Beijing Municipality, China
People's Hospital Under Beijnig University
Beijing, Beijing Municipality, China
The Second Affiliated of ChongQing University of Medical Science
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Department of Infectious Disease, Nanfang Hospital
Guangzhou, Guangdong, China
GuangDong Provincial People's hospital
Guangzhou, Guangdong, China
No. 8 People's Hospital In GuangZhou
Guangzhou, Guangdong, China
The Third Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital Central-South Univrsity
Changsha, Hunan, China
No.81 Hospital of PLA
Nanjing, Jiangsu, China
First Hospital .Jilin Unniversity
Changchun, Jilin, China
ShengJing Hospital of China Medical University
Shengyang, Liaoning, China
JiNan Infectious Diseases Hospital
Jinan, Shandong, China
Changhai Hospital affiliated to Second Military Medical University
Shanghai, Shanghai Municipality, China
Huashan Hospital，Fudan University
Shanghai, Shanghai Municipality, China
No.85 Hospital of PLA
Shanghai, Shanghai Municipality, China
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
Tangdu Hospital
XiAn, Shanxi, China
West China Hospital.SiChuan University
Chengdu, Sichuan, China
HangZhou No.6 People Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2013
First Posted
April 18, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2016
Study Completion
December 1, 2016
Last Updated
June 19, 2014
Record last verified: 2014-06