REALM China Extension Study

November 23, 2016 updated by: Nanfang Hospital of Southern Medical University

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • First Affiliated Hospital of Beijing University
        • Contact:
      • Beijing, China
      • Chongqing, China
        • Recruiting
        • Southwest Hospital Affiliated the Third Military Medical University
        • Contact:
      • Shanghai, China
        • Recruiting
        • Shanghai Public Health Clinical Center
        • Contact:
      • Shanghai, China
      • Shanghai, China
        • Recruiting
        • Changhai Hospital of the Second Military Medical University of Chinese PLA
        • Contact:
      • Shanghai, China
      • Shanghai, China
        • Recruiting
        • Renji Hospital of Shanghai Jiao Tong University
        • Contact:
      • Shanghai, China
        • Recruiting
        • Shanghai jing 'an district central hospital
        • Contact:
      • Shanghai, China
        • Recruiting
        • Shanghai No.5 People's Hospital
        • Contact:
      • Shenzhen, China
        • Recruiting
        • No.3 people's hospital of shenzhen
        • Contact:
      • Tianjin, China
        • Recruiting
        • Tianjin Third Central Hospital
      • Tianjin, China
        • Recruiting
        • Tianjin Infectious Disease Hospital
        • Contact:
    • Anhui
      • Hefei, Anhui, China
        • Recruiting
        • First Affiliated Hospital of Anhui Medical University
        • Contact:
    • Beijing
      • Beijing, Beijing, China
      • Beijing, Beijing, China
      • Beijing, Beijing, China
        • Recruiting
        • People's Hospital of Beijing University
        • Contact:
      • Beijing, Beijing, China
    • Chongqing
      • Chongqing, Chongqing, China
    • Guangdong
      • Guangzhou, Guangdong, China
      • Guangzhou, Guangdong, China
        • Recruiting
        • Guangzhou No. 8 People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China
        • Recruiting
        • Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
    • Guizhou
      • Guiyang, Guizhou, China
        • Recruiting
        • Affiliated Hospital of Guiyang Medical College
        • Contact:
    • Hainan
      • Haikou, Hainan, China
    • Henan
      • Zhengzhou, Henan, China
        • Recruiting
        • First Affiliated Hospital of Zhengzhou University
        • Contact:
      • Zhengzhou, Henan, China
        • Recruiting
        • Medical Science Research Institute of Henan Province
        • Contact:
      • Zhengzhou, Henan, China
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital of Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
      • Changsha, Hunan, China
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China
      • Nanjing, Jiangsu, China
      • Ningbo, Jiangsu, China
        • Recruiting
        • Ningbo infectious disease hospital
        • Contact:
      • Suzhou, Jiangsu, China
        • Recruiting
        • First Affiliated Hospital of Soochow University
        • Contact:
      • Suzhou, Jiangsu, China
        • Recruiting
        • People's hospital of Jiangsu Province
        • Contact:
    • Jilin
      • Changchun, Jilin, China
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • No.6 People's hospital of Dalian
        • Contact:
      • Shengyang, Liaoning, China
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:
      • Shenyang, Liaoning, China
        • Recruiting
        • No.6 People's hospital of Shenyang
        • Contact:
    • Shaanxi
      • Xi'an, Shaanxi, China
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Xi'an, Shaanxi, China
    • Shandong
      • Jinan Shi, Shandong, China
    • Shanghai
      • Shanghai, Shanghai, China
      • Shanghai, Shanghai, China
        • Recruiting
        • No.85 Hospital of PLA
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • First Affiliated Hospital of Shanxi Medical University
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • The First Affiliated Hospital of Kunming Medical College
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • First Affiliated Hospital of Zhejing University
        • Contact:
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Hangzhou No.6 people's hospital
        • Contact:
      • Taizhou, Zhejiang, China
        • Recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic hepatitis B patients

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All patients
Continuing with marketed anti-HBV or off-treatment in real-life setting
Other: follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Treatment patterns in Study AI463520
Time Frame: year 5
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
year 5

Secondary Outcome Measures

Outcome Measure
Time Frame
Antiviral efficacy endpoints on anti-HBV treatment in Studies AI463080 and AI463520.
Time Frame: year 5
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
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
year 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Collaborators

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

November 23, 2016

First Submitted That Met QC Criteria

November 23, 2016

First Posted (Estimate)

November 29, 2016

Study Record Updates

Last Update Posted (Estimate)

November 29, 2016

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI463520

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B, Chronic

Clinical Trials on follow-up

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe