EFFORT Extension Study
- Conditions
- Hepatitis B, Chronic
- Interventions
- Registration Number
- NCT01529255
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- Brief Summary
* The purpose of this study is to to prove that the long-term efficacy of strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.
* To evaluate the off-treatment durability of HBeAg seroconversion in patients who discontinued treatment due to sustained HBeAg seroconversion and HBV DNA\<300copies/ml with over 12 months consolidation treatment
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 576
- Treated with telbivudine or combined with adefovir in EFFORT study
- Patients are willing to participate in the extension study
- Patients provide information consent form
- Adjustment of poor compliance by investigators
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ROADMAP telbivudine (ROADMAP) - SOC (Standard of Care) Telbivudine (Standard of Care) -
- Primary Outcome Measures
Name Time Method The difference of percentage of patients achieving HBV DNA< 300copies/mL at week 48 in Group I and Group II Week 48
- Secondary Outcome Measures
Name Time Method Percentage of patients achieving HBV DNA <300copies/mL at week 156 Week 156 The log10 reduction in HBV DNA from baseline of EFFORT study at week 156 Week 156 Percentage of patients with HBeAg loss or HBeAg seroconversion at week 156 Week 156 Percentage of patients with HBsAg loss or HBsAg seroconversion at week 156 Week 156 The percentage of patients with ALT normalization at week 156 Week 156 Percentage of patients with HBV DNA breakthrough at week 156 Week 156 Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 156 Week 156 sustained response rate of durability of HBeAg seroconversion at week 52 of off-treatment duration week 52 of off-treatment percentage of hepatitis flare at week 52 of off-treatment duration week 52 of off-treatment
Trial Locations
- Locations (24)
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
Department of Infectious Disease, Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
The Sixth People's Hospital of Hangzhou
🇨🇳Hangzhou, Zhejiang, China
Tangdu Hospital
🇨🇳Xian, Shanxi, China
302 Military Hospital Of China
🇨🇳Beijing, Beijing, China
No. 8 People's Hospital In GuangZhou
🇨🇳Guangzhou, Guangdong, China
The Third Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, Guangdong, China
No.81 Hospital of PLA
🇨🇳Nanjing, Jiangsu, 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
First Hospital .Jilin Unniversity
🇨🇳Changchun, Jilin, China
ShengJing Hospital of China Medical University
🇨🇳Shengyang, Liaoning, China
JiNan Infectious Diseases Hospital
🇨🇳Jinan, Shandong, China
No.85 Hospital of PLA
🇨🇳Shanghai, Shanghai, China
Changhai Hospital affiliated to Second Military Medical University
🇨🇳Shanghai, Shanghai, China
Huashan Hospital，Fudan University
🇨🇳Shanghai, Shanghai, China
West China Hospital.SiChuan University
🇨🇳Chengdu, Sichuan, China
Shanghai Ruijin Hospital
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of College of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China