3E Extension Study
- Conditions
- Chronic Hepatitis B
- Interventions
- Drug: oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
- Registration Number
- NCT01834508
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
- 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.
- Subjects who could not compliance with the protocol judged by investigators
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment group oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks -
- Primary Outcome Measures
Name Time Method Percentages of patients achieving HBV DNA< 300copies/mL at week 144 Week 144
- Secondary Outcome Measures
Name Time Method 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 Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 Week 48 & 96
Trial Locations
- Locations (28)
Beijing Ditan Hospita
π¨π³Beijing, Beijing, China
First Hospital .Jilin Unniversity
π¨π³Changchun, Jilin, China
ShengJing Hospital of China Medical University
π¨π³Shengyang, Liaoning, China
Shanghai Ruijin Hospital
π¨π³Shanghai, Shanghai, China
302 Military Hospital Of China
π¨π³Beijing, Beijing, China
BeiJing YouAn Hospital ,Capital Medical University
π¨π³Beijing, Beijing, China
Beijing Friendship Hospital Attached To The Capital Medical University
π¨π³Beijing, Beijing, China
Department of infectious disease, First Hospital of Peking University
π¨π³Beijing, Beijing, China
People's Hospital Under Beijnig University
π¨π³Beijing, Beijing, China
The Second Affiliated of ChongQing University of Medical Science
π¨π³Chongqing, Chongqing, China
The First Affiliated Hospital of Fujian Medical University
π¨π³FuZhou, Fujian, China
The First People's Hospital of Foshan
π¨π³FoShan, Guangdong, China
Department of Infectious Disease, Nanfang Hospital
π¨π³Guangzhou, Guangdong, China
GuangDong Provincial People's hospital
π¨π³GuangZhou, Guangdong, China
The Third Hospital of Sun Yat-Sen University
π¨π³Guangzhou, Guangdong, China
Xiangya Hospital Central-South Univrsity
π¨π³Changsha, Hunan, China
First Affiliated Hospital of Guangxi Medical University
π¨π³NanNing, Guangxi, China
No. 8 People's Hospital In GuangZhou
π¨π³Guangzhou, Guangdong, China
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
π¨π³Wuhan, Hubei, China
Huashan HospitalοΌFudan University
π¨π³Shanghai, Shanghai, China
JiNan Infectious Diseases Hospital
π¨π³Jinan, Shandong, China
Changhai Hospital affiliated to Second Military Medical University
π¨π³Shanghai, Shanghai, China
Tangdu Hospital
π¨π³XiAn, Shanxi, China
No.81 Hospital of PLA
π¨π³Nanjing, Jiangsu, China
No.85 Hospital of PLA
π¨π³Shanghai, Shanghai, China
West China Hospital.SiChuan University
π¨π³Chengdu, Sichuan, China
HangZhou No.6 People Hospital
π¨π³Hangzhou, Zhejiang, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
π¨π³Hangzhou, Zhejiang, China