Hepatitis B, ChronicNCT02974829
REALM China Extension Study
An observational study of Hepatitis B, Chronic, run by Nanfang Hospital, Southern Medical University at 50 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- follow-up
- How many people
- 4,000 participants
- Where
- 50 sitesChina
- Study dates
- May 2016to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chronic hepatitis B patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
China50 sites, 50 recruiting
- Recruiting
302 Military Hospital Of China
Beijing, Beijing Municipality
Jinghua Hu, hjh@medmail.com.cn
- Recruiting
Beijing Ditan Hospital
Beijing, Beijing Municipality
Jun Cheng, jun.cheng.ditan@gmail.com
- Recruiting
Beijing Friendship Hospital
Beijing, Beijing Municipality
Hong Ma, mahongmd@aliyun.com
- Recruiting
People's Hospital of Beijing University
Beijing, Beijing Municipality
Lai Wei, MD, weelai@163.com
- Recruiting
First Affiliated Hospital of Beijing University
Beijing
Xiaoyuan Xu, xiaoyuanxu6@163.com
- Recruiting
You An Hospital
Beijing
Zhongping Duan, duan2517@sohu.com
- Recruiting
First Hospital of Jilin Unniversity
Changchun, Jilin
Junqi Niu, junqiniu@aliyun.com
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Yongfang Jiang, jiangyongfang@hotmail.com
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan
Deming Tan, dmt3008@163.com
- Recruiting
West China Hospital of SiChuan University
Chengdu, Sichuan
Hong Tang, htang6198@hotmail.com
- Recruiting
The Second Affiliated of ChongQing University of Medical Science
Chongqing, Chongqing Municipality
Hong Ren, renhong0531@vip.sina.com.cn
- Recruiting
Southwest Hospital Affiliated the Third Military Medical University
Chongqing
Jijun Zhou, 13883088455@139.com
- Recruiting
No.6 People's hospital of Dalian
Dalian, Liaoning
Gongchen Wang, wgc8602@sohu.com
- Recruiting
GuangZhou No. 8 People's Hospital
Guangzhou, Guangdong
Min Xu, gz8hxm@126.com
- Recruiting
Nanfang Hospital
Guangzhou, Guangdong
Jinlin Hou, jlhousmu@163.com
- Recruiting
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong
Dongying Xie, xdy-gz@163.com
- Recruiting
Affiliated Hospital of Guiyang Medical College
Guiyang, Guizhou
Mingliang Cheng, chengml@21cn.com
- Recruiting
People's hospital of Hainan Province
Haikou, Hainan
Feng Lin, lin_fenghn@aliyun.com
- Recruiting
First Affiliated Hospital of Zhejing University
Hangzhou, Zhejiang
Qi Xia, xiaqi1980@163.com
- Recruiting
Hangzhou No.6 people's hospital
Hangzhou, Zhejiang
Huimin Liu, 1557585971@qq.com
- Recruiting
First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Huafa Yin, yhf163.good@163.com
- Recruiting
Jinan infectious disease hospital
Jinan, Shandong
Qiang Li, doctorliqiang@aliyun.com
- Recruiting
The first affiliated hospital of kunming medical college
Kunming, Yunnan
Wu Li, liwukm@qq.com
- Recruiting
No.81 Hospital of PLA
Nanjing, Jiangsu
Maorong Wang, maorongwang@126.com
- Recruiting
The second hospital of nanjing
Nanjing, Jiangsu
Wei Zhao, zhaohong6401@sina.com
- Recruiting
Ningbo infectious disease hospital
Ningbo, Jiangsu
Hao Ying, yinghao66@126.com
- Recruiting
No.85 Hospital of PLA
Shanghai, Shanghai Municipality
Chengwei Chen, ccw2@163.com
- Recruiting
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality
Qing Xie, xieqingrjh@163.com
- Recruiting
Changhai Hospital of the Second Military Medical University of Chinese PLA
Shanghai
Chengzhong Li, leo_lee66@126.com
- Recruiting
Huashan hospital of fudan university
Shanghai
Wenhong Zhang, zhangwenhong@fudan.edu.cn
- Recruiting
Renji Hospital of Shanghai Jiao Tong University
Shanghai
Yimin Mao, maoym11968@163.com
- Recruiting
Shanghai jing 'an district central hospital
Shanghai
Hong Wang, 13501762950@163.com
- Recruiting
Shanghai No.5 People's Hospital
Shanghai
Desheng Xie, deshengxie@163.com
- Recruiting
Shanghai Public Health Clinical Center
Shanghai
Jiefei Wang, wjf_sm@126.com
- Recruiting
Zhongshan Hospital of Fudan University
Shanghai
Shuncai Zhang, doctorzhangsc@163.com
- Recruiting
ShengJing Hospital of China Medical University
Shengyang, Liaoning
Xiaoguang Dou, guang40@163.com
- Recruiting
No.6 People's hospital of Shenyang
Shenyang, Liaoning
Mingxiang Zhang, zmx6511@126.com
- Recruiting
No.3 people's hospital of shenzhen
Shenzhen
Feijian Ao, szaofj@163.com
- Recruiting
First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Jianhe Gan, ganjianhe@aliyun.com
- Recruiting
People's hospital of Jiangsu Province
Suzhou, Jiangsu
Donghui Zhou, dr-zhou@vip.sina.com
- Recruiting
First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi
Longfeng Zhao, zhaolf006@163.com
- Recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang
Huazhong Chen, docchz@126.com
- Recruiting
Tianjin infectious disease hospital
Tianjin
Yuqiang Mi, yuqiangmi68@163.com
- Recruiting
Tianjin third central hospital
Tianjin
Tao Han, hantaomd@126.com
- Recruiting
Tongji Hospital of Huazhong University of Science and Technology
Wuhan, Hubei
Zhengang Zhang, zhangzhg@126.com
- Recruiting
Tangdu Hospital
Xi'an, Shaanxi
Jianqi Lian, lianjq@fmmu.edu.cn
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
Shumei Lin, linshumei123@126.com
- Recruiting
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Zujiang Yu, johnyuem@zzu.edu.cn
- Recruiting
Medical Science Research Institute of Henan Province
Zhengzhou, Henan
Aimin Sun, aiminsunzz@163.com
- Recruiting
People's Hospital of Henan Province
Zhengzhou, Henan
Jia Shang, shangjia666@126.com
About this study
Official title: A 5-Year Follow-up Study of Subjects Who Completed REALM-China Study
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
- Conditions
- Hepatitis B, Chronic
- Being tested
- follow-up
- Keywords
- Chronic Hepatitis B
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
follow-upOther
| Study group | Role | What they receive |
|---|---|---|
| All patients | Continuing with marketed anti-HBV or off-treatment in real-life setting Receives: Other: follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment patterns in Study AI463520
Measured: 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.
Measured: year 5
Secondary outcomes (3)
Antiviral efficacy endpoints on anti-HBV treatment in Studies AI463080 and AI463520.
Measured: year 5
Multivariate logistic regression models evaluating the relationship between pre-treatment biomarkers and antiviral efficacy endpoints on anti-HBV treatment in Study
Measured: year 5
Multivariate logistic regression models evaluating the relationship between baseline liver stiffness measurement (LSM) and HBV-related COEs outcomes in Study AI463520.
Measured: year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974829
- Sponsor's protocol ID
- AI463520
- Status last verified
- Nov 2016
- First submitted
- 23 Nov 2016
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 5-Year Follow-up Study of Subjects Who Completed REALM-China Study
- ClinicalTrials.gov ID
- NCT02974829
- Acronym / sponsor ID
- AI463520
- Conditions
- Hepatitis B, Chronic
- Keywords
- Chronic Hepatitis B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- May 2016
- Primary completion
- Jan 2022 (estimated)
- First posted
- 29 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | – | Other: follow-upContinuing with marketed anti-HBV or off-treatment in real-life setting |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chronic hepatitis B patients
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| follow-up | Other | All patients |
Primary outcome
Treatment patterns in Study AI463520
Time frame: 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.
Time frame: year 5
3 secondary outcomes
Antiviral efficacy endpoints on anti-HBV treatment in Studies AI463080 and AI463520.
Time frame: year 5
Multivariate logistic regression models evaluating the relationship between pre-treatment biomarkers and antiviral efficacy endpoints on anti-HBV treatment in Study
Time frame: year 5
Multivariate logistic regression models evaluating the relationship between baseline liver stiffness measurement (LSM) and HBV-related COEs outcomes in Study AI463520.
Time frame: year 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic, run by Nanfang Hospital, Southern Medical University at 50 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment patterns in Study AI463520 (time frame: year 5). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.