Clinical trial NCT01088009: Efficacy Optimizing Research of Lamivudine Therapy
Official title: A Prospective, Randomised, Open-label, Multi-centre Study to Compare Three Chronic Hepatitis B (CHB) Treatment Strategies Over a 2year Period in Chinese HBeAg Positive CHB Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Compensated Chronic Hepatitis B
Keywords: 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: GlaxoSmithKline
First posted: 2010-03-16
Enrollment: 366
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 compare the adefovir early add-on to rescue therapy strategy, and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.


Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-65 years;
* Capable of understanding and signing the informed consent. Willing to comply with the study requirements;
* Serum HBsAg and HBeAg positive at study screening; Documented chronic hepatitis B infection determined by the presence of serum HBsAg for at least 6 months;

Exclusion Criteria:

* History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
* other protocol defined inclusion/exclusion criteria

Primary outcomes:
measure: the proportion of virological breakthrough with confirmed Lamivudine resistant mutants
timeFrame: during 104 weeks study period
Secondary outcomes:
measure: proportion of subjects with hepatitis B virus (HBV) DNA≤300 copies/mL
timeFrame: week 104
measure: Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104
timeFrame: baseline, week 104
measure: The proportion of subjects with ALT normalization at week 104
timeFrame: week 104
measure: The proportion of subjects with HBeAg loss and seroconversion at week 104
timeFrame: week 104
measure: The proportion of subjects with HBsAg loss and seroconversion rates at week 104
timeFrame: week 104
Other outcomes:
Locations:
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: FuZhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: FoShan
country: China
facility: The First People's Hospital of Foshan
state: Guangdong
city: GuangZhou
country: China
facility: Department of infectious disease, Nanfang Hospital
state: Guangdong
city: GuangZhou
country: China
facility: GuangDong Provincial People's hospital
state: Guangdong
city: NanNing
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
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: ChangChun
country: China
facility: First Hospital .Jilin Unniversity
state: Jilin
city: ShenYang
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: HangZhou No.6 People Hospital
state: Zhejiang
city: HangZhou
country: China
facility: The First Affiliated Hospital of College of Medicine ，Zhejiang University
state: Zhejiang
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: JinLin Hou, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xiang KH, Michailidis E, Ding H, Peng YQ, Su MZ, Li Y, Liu XE, Dao Thi VL, Wu XF, Schneider WM, Rice CM, Zhuang H, Li T. Effects of amino acid substitutions in hepatitis B virus surface protein on virion secretion, antigenicity, HBsAg and viral DNA. J Hepatol. 2017 Feb;66(2):288-296. doi: 10.1016/j.jhep.2016.09.005. Epub 2016 Sep 17.