REALM China Extension Study
A 5-Year Follow-up Study of Subjects Who Completed REALM-China Study
1 other identifier
observational
4,000
1 country
50
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 23, 2016
CompletedFirst Posted
Study publicly available on registry
November 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedNovember 29, 2016
November 1, 2016
5.7 years
November 23, 2016
November 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Treatment patterns in Study AI463520
year 5
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
Secondary Outcomes (3)
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
Study Arms (1)
All patients
Continuing with marketed anti-HBV or off-treatment in real-life setting
Interventions
Eligibility Criteria
Chronic hepatitis B patients
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
302 Military Hospital Of China
Beijing, Beijing Municipality, China
Beijing Ditan Hospital
Beijing, Beijing Municipality, China
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
People's Hospital of Beijing University
Beijing, Beijing Municipality, China
The Second Affiliated of ChongQing University of Medical Science
Chongqing, Chongqing Municipality, 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
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Medical Science Research Institute of Henan Province
Zhengzhou, Henan, China
People's Hospital of Henan Province
Zhengzhou, Henan, China
Tongji Hospital of Huazhong University of Science and Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Xiangya Hospital 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
First Hospital of Jilin Unniversity
Changchun, Jilin, China
No.6 People's hospital of Dalian
Dalian, Liaoning, 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, Shandong, China
No.85 Hospital of PLA
Shanghai, Shanghai Municipality, China
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
West China Hospital of SiChuan University
Chengdu, Sichuan, China
The first affiliated hospital of kunming medical college
Kunming, Yunnan, 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
Southwest Hospital Affiliated the Third Military Medical University
Chongqing, China
Changhai Hospital of the Second Military Medical University of Chinese PLA
Shanghai, 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
Zhongshan Hospital of Fudan University
Shanghai, China
No.3 people's hospital of shenzhen
Shenzhen, China
Tianjin infectious disease hospital
Tianjin, China
Tianjin third central hospital
Tianjin, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2016
First Posted
November 29, 2016
Study Start
May 1, 2016
Primary Completion
January 1, 2022
Last Updated
November 29, 2016
Record last verified: 2016-11