CClinicalTrials.gg
Sign In
Status unknownNCT02974829Updated Nov 29, 2016

REALM China Extension Study

An observational study in Hepatitis B, Chronic, sponsored by Nanfang Hospital, Southern Medical University. Status unknown at 50 sites in China. Per ClinicalTrials.gov, last updated 2016-11-29.

Sponsored by Nanfang Hospital, Southern Medical University · Observational

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,000
Sex
All
01

Study 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

02

Conditions studied

  • Hepatitis B, Chronic

Keywords

  • Chronic Hepatitis B
03

In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's planned enrollment of 4,000 is above the median of 390 across 407 observational studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Chronic hepatitis B patients

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • All patients

    Continuing with marketed anti-HBV or off-treatment in real-life setting

    Other: follow-up

Interventions

  • Otherfollow-up
06

What researchers measure

Primary outcomes

  1. Treatment patterns in Study AI463520

    Time frame: year 5

  2. 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

Secondary outcomes

  1. Antiviral efficacy endpoints on anti-HBV treatment in Studies AI463080 and AI463520.

    Time frame: year 5

  2. 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

  3. 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

07

Study locations

50 of 50 sites recruiting
  • First Affiliated Hospital of Anhui Medical University
    Hefei, Anhui, China
    Recruiting
  • 302 Military Hospital Of China
    Beijing, Beijing, China
    Recruiting
  • Beijing Ditan Hospital
    Beijing, Beijing, China
    Recruiting
  • Beijing Friendship Hospital
    Beijing, Beijing, China
    Recruiting
  • People's Hospital of Beijing University
    Beijing, Beijing, China
    Recruiting
  • The Second Affiliated of ChongQing University of Medical Science
    Chongqing, Chongqing, China
    Recruiting
  • GuangZhou No. 8 People's Hospital
    Guangzhou, Guangdong, China
    Recruiting
  • Nanfang Hospital
    Guangzhou, Guangdong, China
    Recruiting
  • Third Affiliated Hospital of Sun Yat-sen University
    Guangzhou, Guangdong, China
    Recruiting
  • Affiliated Hospital of Guiyang Medical College
    Guiyang, Guizhou, China
    Recruiting
  • People's hospital of Hainan Province
    Haikou, Hainan, China
    Recruiting
  • First Affiliated Hospital of Zhengzhou University
    Zhengzhou, Henan, China
    Recruiting
  • Medical Science Research Institute of Henan Province
    Zhengzhou, Henan, China
    Recruiting
  • People's Hospital of Henan Province
    Zhengzhou, Henan, China
    Recruiting
  • Tongji Hospital of Huazhong University of Science and Technology
    Wuhan, Hubei, China
    Recruiting
  • The Second Xiangya Hospital of Central South University
    Changsha, Hunan, China
    Recruiting
  • Xiangya Hospital Central South University
    Changsha, Hunan, China
    Recruiting
  • No.81 Hospital of PLA
    Nanjing, Jiangsu, China
    Recruiting
  • The second hospital of nanjing
    Nanjing, Jiangsu, China
    Recruiting
  • Ningbo infectious disease hospital
    Ningbo, Jiangsu, China
    Recruiting
  • First Affiliated Hospital of Soochow University
    Suzhou, Jiangsu, China
    Recruiting
  • People's hospital of Jiangsu Province
    Suzhou, Jiangsu, China
    Recruiting
  • First Hospital of Jilin Unniversity
    Changchun, Jilin, China
    Recruiting
  • No.6 People's hospital of Dalian
    Dalian, Liaoning, China
    Recruiting
  • ShengJing Hospital of China Medical University
    Shengyang, Liaoning, China
    Recruiting
  • No.6 People's hospital of Shenyang
    Shenyang, Liaoning, China
    Recruiting
  • Tangdu Hospital
    Xi'an, Shaanxi, China
    Recruiting
  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi, China
    Recruiting
  • Jinan infectious disease hospital
    Jinan Shi, Shandong, China
    Recruiting
  • No.85 Hospital of PLA
    Shanghai, Shanghai, China
    Recruiting
  • Shanghai Ruijin Hospital
    Shanghai, Shanghai, China
    Recruiting
  • First Affiliated Hospital of Shanxi Medical University
    Taiyuan, Shanxi, China
    Recruiting
  • West China Hospital of SiChuan University
    Chengdu, Sichuan, China
    Recruiting
  • The first affiliated hospital of kunming medical college
    Kunming, Yunnan, China
    Recruiting
  • First Affiliated Hospital of Zhejing University
    Hangzhou, Zhejiang, China
    Recruiting
  • Hangzhou No.6 people's hospital
    Hangzhou, Zhejiang, China
    Recruiting
  • Taizhou Hospital of Zhejiang Province
    Taizhou, Zhejiang, China
    Recruiting
  • First Affiliated Hospital of Beijing University
    Beijing, China
    Recruiting
  • You An Hospital
    Beijing, China
    Recruiting
  • Southwest Hospital Affiliated the Third Military Medical University
    Chongqing, China
    Recruiting
  • Changhai Hospital of the Second Military Medical University of Chinese PLA
    Shanghai, China
    Recruiting
  • Huashan hospital of fudan university
    Shanghai, China
    Recruiting
  • Renji Hospital of Shanghai Jiao Tong University
    Shanghai, China
    Recruiting
  • Shanghai jing 'an district central hospital
    Shanghai, China
    Recruiting
  • Shanghai No.5 People's Hospital
    Shanghai, China
    Recruiting
  • Shanghai Public Health Clinical Center
    Shanghai, China
    Recruiting
  • Zhongshan Hospital of Fudan University
    Shanghai, China
    Recruiting
  • No.3 people's hospital of shenzhen
    Shenzhen, China
    Recruiting
  • Tianjin infectious disease hospital
    Tianjin, China
    Recruiting
  • Tianjin third central hospital
    Tianjin, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02974829
Lead sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Nov 29, 2016
Start date
May 2016
Primary completion
Jan 2022 (estimated)
Last update
Nov 29, 2016

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hepatitis B→

Other studies from this sponsor

Nanfang Hospital, Southern Medical University

Start the discussion