REALM China Extension Study
- Conditions
- Hepatitis B, Chronic
- Interventions
- Other: follow-up
- Registration Number
- NCT02974829
- Lead Sponsor
- Nanfang Hospital, Southern Medical University
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 4000
- Patients completed REALM Study in China
- 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.
- Patients who do not provide consent to participate in this study;
- Patients are formally enrolled into any investigational drug clinical trial after the REALM study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description All patients follow-up Continuing with marketed anti-HBV or off-treatment in real-life setting
- Primary Outcome Measures
Name Time Method 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. year 5 Treatment patterns in Study AI463520 year 5
- Secondary Outcome Measures
Name Time Method Antiviral efficacy endpoints on anti-HBV treatment in Studies AI463080 and AI463520. year 5 Multivariate logistic regression models evaluating the relationship between pre-treatment biomarkers and antiviral efficacy endpoints on anti-HBV treatment in Study year 5 Multivariate logistic regression models evaluating the relationship between baseline liver stiffness measurement (LSM) and HBV-related COEs outcomes in Study AI463520. year 5
Trial Locations
- Locations (50)
First Hospital of Jilin Unniversity
🇨🇳Changchun, Jilin, China
No.6 People's hospital of Dalian
🇨🇳Dalian, Liaoning, China
Zhongshan Hospital of Fudan University
🇨🇳Shanghai, China
First Affiliated Hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
302 Military Hospital Of China
🇨🇳Beijing, Beijing, China
Beijing Ditan Hospital
🇨🇳Beijing, Beijing, China
The Second Affiliated of ChongQing University of Medical Science
🇨🇳Chongqing, Chongqing, China
Beijing Friendship Hospital
🇨🇳Beijing, Beijing, China
People's Hospital of Beijing University
🇨🇳Beijing, Beijing, China
GuangZhou No. 8 People's Hospital
🇨🇳Guangzhou, Guangdong, China
Nanfang Hospital
🇨🇳Guangzhou, Guangdong, China
Third Affiliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Affiliated Hospital of Guiyang Medical College
🇨🇳Guiyang, Guizhou, China
People's hospital of Hainan Province
🇨🇳Haikou, Hainan, China
Medical Science Research Institute of Henan Province
🇨🇳Zhengzhou, Henan, China
First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
People's Hospital of Henan Province
🇨🇳Zhengzhou, Henan, China
Tongji Hospital of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
No.81 Hospital of PLA
🇨🇳Nanjing, Jiangsu, China
The second hospital of nanjing
🇨🇳Nanjing, Jiangsu, China
Ningbo infectious disease hospital
🇨🇳Ningbo, Jiangsu, China
First Affiliated Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
People's hospital of Jiangsu Province
🇨🇳Suzhou, Jiangsu, China
ShengJing Hospital of China Medical University
🇨🇳Shengyang, Liaoning, China
No.6 People's hospital of Shenyang
🇨🇳Shenyang, Liaoning, China
Tangdu Hospital
🇨🇳Xi'an, Shaanxi, China
The First Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xi'an, Shaanxi, China
Jinan infectious disease hospital
🇨🇳Jinan Shi, Shandong, China
No.85 Hospital of PLA
🇨🇳Shanghai, Shanghai, China
First Affiliated Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Shanghai Ruijin Hospital
🇨🇳Shanghai, Shanghai, China
The first affiliated hospital of kunming medical college
🇨🇳Kunming, Yunnan, China
West China Hospital of SiChuan University
🇨🇳Chengdu, Sichuan, China
First Affiliated Hospital of Zhejing University
🇨🇳Hangzhou, Zhejiang, China
Hangzhou No.6 people's hospital
🇨🇳Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province
🇨🇳Taizhou, Zhejiang, China
First Affiliated Hospital of Beijing University
🇨🇳Beijing, China
You An Hospital
🇨🇳Beijing, China
Changhai Hospital of the Second Military Medical University of Chinese PLA
🇨🇳Shanghai, China
Southwest Hospital Affiliated the Third Military Medical University
🇨🇳Chongqing, China
Huashan hospital of fudan university
🇨🇳Shanghai, China
Renji Hospital of Shanghai Jiao Tong University
🇨🇳Shanghai, China
Shanghai jing 'an district central hospital
🇨🇳Shanghai, China
Shanghai No.5 People's Hospital
🇨🇳Shanghai, China
Shanghai Public Health Clinical Center
🇨🇳Shanghai, China
No.3 people's hospital of shenzhen
🇨🇳Shenzhen, China
Tianjin infectious disease hospital
🇨🇳Tianjin, China
Tianjin third central hospital
🇨🇳Tianjin, China