Clinical trial NCT01529255: EFFORT Extension Study
Official title: A 3-year, Open-label, Multi-center Extension Trial of Telbivudine Therapy for Patients Previously Treated in EFFORT Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Keywords: Chronic Hepatitis B
Compensated Chronic hepatitis B
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Major Science and Technology Special Project of China Eleventh Five-year
name: Novartis
First posted: 2012-02-08
Enrollment: 576
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* Treated with telbivudine or combined with adefovir in EFFORT study
* Patients are willing to participate in the extension study
* Patients provide information consent form

Exclusion Criteria:

* Adjustment of poor compliance by investigators

Primary outcomes:
measure: The difference of percentage of patients achieving HBV DNA< 300copies/mL at week 48 in Group I and Group II
timeFrame: Week 48
Secondary outcomes:
measure: Percentage of patients achieving HBV DNA <300copies/mL at week 156
timeFrame: Week 156
measure: The log10 reduction in HBV DNA from baseline of EFFORT study at week 156
timeFrame: Week 156
measure: Percentage of patients with HBeAg loss or HBeAg seroconversion at week 156
timeFrame: Week 156
measure: Percentage of patients with HBsAg loss or HBsAg seroconversion at week 156
timeFrame: Week 156
measure: The percentage of patients with ALT normalization at week 156
timeFrame: Week 156
measure: Percentage of patients with HBV DNA breakthrough at week 156
timeFrame: Week 156
measure: Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 156
timeFrame: Week 156
measure: sustained response rate of durability of HBeAg seroconversion at week 52 of off-treatment duration
timeFrame: week 52 of off-treatment
measure: percentage of hepatitis flare at week 52 of off-treatment duration
timeFrame: week 52 of off-treatment
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: Guangzhou
country: China
facility: Department of Infectious Disease, Nanfang 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: 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: The First Affiliated Hospital of College of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: The Sixth People's Hospital of Hangzhou
state: Zhejiang
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jinlin Hou, MD
role: PRINCIPAL_INVESTIGATOR
References: