Clinical trial NCT01834508: 3E Extension Study
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Chronic Hepatitis B
Keywords: Experienced Treatment
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Major Science and Technology Special Project of China 12th Five-year
First posted: 2013-04-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentages of patients achieving HBV DNA< 300copies/mL at week 144
timeFrame: Week 144
Secondary outcomes:
measure: Percentages of patients achieving HBV DNA <300copies/mL at week 48/96
timeFrame: Week 48 & 96
measure: The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144
timeFrame: Week 48 & 96 &144
measure: Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.
timeFrame: Week 48 & 96 & 144
measure: Percentage of patients with ALT normalization at week 48/96/144
timeFrame: Week 48 & 96 & 144
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 Military Hospital Of China
state: Beijing
city: Beijing
country: China
facility: Beijing Ditan Hospita
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital Attached To The Capital Medical University
state: Beijing
city: Beijing
country: China
facility: BeiJing YouAn Hospital ,Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Department of infectious disease, First Hospital of Peking University
state: Beijing
city: Beijing
country: China
facility: People's Hospital Under Beijnig University
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated of ChongQing University of Medical Science
state: Chongqing
city: FuZhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: FoShan
country: China
facility: The First People's Hospital of Foshan
state: Guangdong
city: Guangzhou
country: China
facility: Department of Infectious Disease, Nanfang Hospital
state: Guangdong
city: GuangZhou
country: China
facility: GuangDong Provincial People's hospital
state: Guangdong
city: Guangzhou
country: China
facility: No. 8 People's Hospital In GuangZhou
state: Guangdong
city: Guangzhou
country: China
facility: The Third Hospital of Sun Yat-Sen University
state: Guangdong
city: NanNing
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central-South Univrsity
state: Hunan
city: Nanjing
country: China
facility: No.81 Hospital of PLA
state: Jiangsu
city: Changchun
country: China
facility: First Hospital .Jilin Unniversity
state: Jilin
city: Shengyang
country: China
facility: ShengJing Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: JiNan Infectious Diseases Hospital
state: Shandong
city: Shanghai
country: China
facility: Changhai Hospital affiliated to Second Military Medical University
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital，Fudan University
state: Shanghai
city: Shanghai
country: China
facility: No.85 Hospital of PLA
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
city: XiAn
country: China
facility: Tangdu Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital.SiChuan University
state: Sichuan
city: Hangzhou
country: China
facility: HangZhou No.6 People Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: