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)
302 Military Hospital Of China
🇨🇳Beijing, Beijing, China
Beijing Ditan Hospita
🇨🇳Beijing, Beijing, China
Beijing Friendship Hospital Attached To The Capital Medical University
🇨🇳Beijing, Beijing, China
BeiJing YouAn Hospital ,Capital Medical University
🇨🇳Beijing, Beijing, China
Department of infectious disease, First Hospital of Peking University
🇨🇳Beijing, Beijing, China
People's Hospital Under Beijnig University
🇨🇳Beijing, Beijing, China
The Second Affiliated of ChongQing University of Medical Science
🇨🇳Chongqing, Chongqing, 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
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