Clinical trial NCT02974829: REALM China Extension Study
Official title: A 5-Year Follow-up Study of Subjects Who Completed REALM-China Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B, Chronic
Keywords: Chronic Hepatitis B
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2016-11-29
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chronic hepatitis B patients

Brief summary: The purpose of this study is to conduct an investigator initiated observational study to continue to follow up the China subset of study participants for another 5 years after they complete participation in the REALM Study


Eligibility criteria: Inclusion Criteria:

1. Patients completed REALM Study in China
2. Patients willing to sign the consent to continue anti-viral treatment or post-treatment follow up, and agree his/her legacy data and blood/liver histology samples collected in REALM Study may be used for the analyses planned for this new study.

Exclusion Criteria:

1. Patients who do not provide consent to participate in this study;
2. Patients are formally enrolled into any investigational drug clinical trial after the REALM study.

Primary outcomes:
measure: Treatment patterns in Study AI463520
timeFrame: year 5
measure: Incidence rates of hepatitis B virus (HBV)-related clinical outcome events (COEs), such as non-hepatocellular carcinoma (HCC) HBV progression, HCC, and liver-related mortality, in Studies AI463080 and AI463520 combined, and in Study AI463520.
timeFrame: year 5
Secondary outcomes:
measure: Antiviral efficacy endpoints on anti-HBV treatment in Studies AI463080 and AI463520.
timeFrame: year 5
measure: Multivariate logistic regression models evaluating the relationship between pre-treatment biomarkers and antiviral efficacy endpoints on anti-HBV treatment in Study
timeFrame: year 5
measure: Multivariate logistic regression models evaluating the relationship between baseline liver stiffness measurement (LSM) and HBV-related COEs outcomes in Study AI463520.
timeFrame: year 5
Other outcomes:
Locations:
city: Hefei
country: China
facility: First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: 302 Military Hospital Of China
state: Beijing
city: Beijing
country: China
facility: Beijing Ditan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: People's Hospital of Beijing University
state: Beijing
city: Chongqing
country: China
facility: The Second Affiliated of ChongQing University of Medical Science
state: Chongqing
city: Guangzhou
country: China
facility: GuangZhou No. 8 People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guiyang
country: China
facility: Affiliated Hospital of Guiyang Medical College
state: Guizhou
city: Haikou
country: China
facility: People's hospital of Hainan Province
state: Hainan
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Medical Science Research Institute of Henan Province
state: Henan
city: Zhengzhou
country: China
facility: People's Hospital of Henan Province
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital of Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Nanjing
country: China
facility: No.81 Hospital of PLA
state: Jiangsu
city: Nanjing
country: China
facility: The second hospital of nanjing
state: Jiangsu
city: Ningbo
country: China
facility: Ningbo infectious disease hospital
state: Jiangsu
city: Suzhou
country: China
facility: First Affiliated Hospital of Soochow University
state: Jiangsu
city: Suzhou
country: China
facility: People's hospital of Jiangsu Province
state: Jiangsu
city: Changchun
country: China
facility: First Hospital of Jilin Unniversity
state: Jilin
city: Dalian
country: China
facility: No.6 People's hospital of Dalian
state: Liaoning
city: Shengyang
country: China
facility: ShengJing Hospital of China Medical University
state: Liaoning
city: Shenyang
country: China
facility: No.6 People's hospital of Shenyang
state: Liaoning
city: Xi'an
country: China
facility: Tangdu Hospital
state: Shaanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan Shi
country: China
facility: Jinan infectious disease hospital
state: Shandong
city: Shanghai
country: China
facility: No.85 Hospital of PLA
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
city: Taiyuan
country: China
facility: First Affiliated Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of SiChuan University
state: Sichuan
city: Kunming
country: China
facility: The first affiliated hospital of kunming medical college
state: Yunnan
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejing University
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou No.6 people's hospital
state: Zhejiang
city: Taizhou
country: China
facility: Taizhou Hospital of Zhejiang Province
state: Zhejiang
city: Beijing
country: China
facility: First Affiliated Hospital of Beijing University
city: Beijing
country: China
facility: You An Hospital
city: Chongqing
country: China
facility: Southwest Hospital Affiliated the Third Military Medical University
city: Shanghai
country: China
facility: Changhai Hospital of the Second Military Medical University of Chinese PLA
city: Shanghai
country: China
facility: Huashan hospital of fudan university
city: Shanghai
country: China
facility: Renji Hospital of Shanghai Jiao Tong University
city: Shanghai
country: China
facility: Shanghai jing 'an district central hospital
city: Shanghai
country: China
facility: Shanghai No.5 People's Hospital
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
city: Shanghai
country: China
facility: Zhongshan Hospital of Fudan University
city: Shenzhen
country: China
facility: No.3 people's hospital of shenzhen
city: Tianjin
country: China
facility: Tianjin infectious disease hospital
city: Tianjin
country: China
facility: Tianjin third central hospital
Study officials:
References: