576
Participants
Start Date
August 31, 2011
Primary Completion Date
August 31, 2015
Study Completion Date
December 31, 2015
telbivudine (ROADMAP)
"Patients will receive oral telbivudine 600mg, daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily~Stopping rules:~The participants who achieve HBeAg seroconversion and HBV DNA\<300copies/ml with over 12 months consolidation treatment in EFFORT study will discontinue treatment.~The participants who don't meet the rules above will continue their previous treatment and follow up at the interval of 12 weeks until they finish the 156 weeks therapy or achieve the stopping rules.~Follow up： The participants who stopped treatment will follow up at the interval of 12 weeks for 52 weeks. Of these patients, if they have confirmed virologic relapse during follow-up period, they will be excluded from the trial."
Telbivudine (Standard of Care)
"Patients will receive oral telbivudine 600mg, daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily~Stopping rules:~The participants who achieve HBeAg seroconversion and HBV DNA\<300copies/ml with over 12 months consolidation treatment in EFFORT study will discontinue treatment.~The participants who don't meet the rules above will continue their previous treatment and follow up at the interval of 12 weeks until they finish the 156 weeks therapy or achieve the stopping rules.~Follow up： The participants who stopped treatment will follow up at the interval of 12 weeks for 52 weeks. Of these patients, if they have confirmed virologic relapse during follow-up period, they will be excluded from the trial."
302 Military Hospital Of China, Beijing
Beijing Ditan Hospita, Beijing
Beijing Friendship Hospital Attached To The Capital Medical University, Beijing
BeiJing YouAn Hospital ,Capital Medical University, Beijing
Department of Infectious Disease, First Hospital of Peking University, Beijing
People's Hospital Under Beijnig University, Beijing
The Second Affiliated of ChongQing University of Medical Science, Chongqing
Department of Infectious Disease, Nanfang Hospital, Guangzhou
No. 8 People's Hospital In GuangZhou, Guangzhou
The Third Hospital of Sun Yat-Sen University, Guangzhou
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan
Xiangya Hospital Central-South Univrsity, Changsha
No.81 Hospital of PLA, Nanjing
First Hospital .Jilin Unniversity, Changchun
ShengJing Hospital of China Medical University, Shengyang
JiNan Infectious Diseases Hospital, Jinan
Changhai Hospital affiliated to Second Military Medical University, Shanghai
Huashan Hospital，Fudan University, Shanghai
No.85 Hospital of PLA, Shanghai
Shanghai Ruijin Hospital, Shanghai
Tangdu Hospital, Xian
West China Hospital.SiChuan University, Chengdu
The First Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou
The Sixth People's Hospital of Hangzhou, Hangzhou
Collaborators (1)
Major Science and Technology Special Project of China Eleventh Five-year
OTHER
Novartis
INDUSTRY
Nanfang Hospital, Southern Medical University
OTHER