REALM China Extension Study

Hepatitis B, Chronic Clinical Trial

Official title:

A 5-Year Follow-up Study of Subjects Who Completed REALM-China Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02974829
• Other study ID #: AI463520
• Status: Recruiting
• Phase: N/A
• First received: November 23, 2016
• Last updated: November 23, 2016
• Start date: May 2016

Study information

• Verified date: November 2016
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Other:
• follow-up

Locations

Country	Name	City	State
China	302 Military Hospital Of China	Beijing	Beijing
China	Beijing Ditan Hospital	Beijing	Beijing
China	Beijing Friendship Hospital	Beijing	Beijing
China	First Affiliated Hospital of Beijing University	Beijing
China	People's Hospital of Beijing University	Beijing	Beijing
China	You An Hospital	Beijing
China	First Hospital of Jilin Unniversity	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital of SiChuan University	Chengdu	Sichuan
China	Southwest Hospital Affiliated the Third Military Medical University	Chongqing
China	The Second Affiliated of ChongQing University of Medical Science	Chongqing	Chongqing
China	No.6 People's hospital of Dalian	Dalian	Liaoning
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 Zhejing University	Hangzhou	Zhejiang
China	Hangzhou No.6 people's hospital	Hangzhou	Zhejiang
China	First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Jinan infectious disease hospital	Jinan Shi	Shandong
China	The first affiliated hospital of kunming medical college	Kunming	Yunnan
China	No.81 Hospital of PLA	Nanjing	Jiangsu
China	The second hospital of nanjing	Nanjing	Jiangsu
China	Ningbo infectious disease hospital	Ningbo	Jiangsu
China	Changhai Hospital of the Second Military Medical University of Chinese PLA	Shanghai
China	Huashan hospital of fudan university	Shanghai
China	No.85 Hospital of PLA	Shanghai	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	Shanghai Ruijin Hospital	Shanghai	Shanghai
China	Zhongshan Hospital of Fudan University	Shanghai
China	ShengJing Hospital of China Medical University	Shengyang	Liaoning
China	No.6 People's hospital of Shenyang	Shenyang	Liaoning
China	No.3 people's hospital of shenzhen	Shenzhen
China	First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	People's hospital of Jiangsu Province	Suzhou	Jiangsu
China	First Affiliated Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	Tianjin infectious disease hospital	Tianjin
China	Tianjin third central hospital	Tianjin
China	Tongji Hospital of Huazhong University of Science and Technology	Wuhan	Hubei
China	Tangdu Hospital	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
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

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment patterns in Study AI463520		year 5	No
Primary	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	No
Secondary	Antiviral efficacy endpoints on anti-HBV treatment in Studies AI463080 and AI463520.		year 5	No
Secondary	Multivariate logistic regression models evaluating the relationship between pre-treatment biomarkers and antiviral efficacy endpoints on anti-HBV treatment in Study		year 5	No
Secondary	Multivariate logistic regression models evaluating the relationship between baseline liver stiffness measurement (LSM) and HBV-related COEs outcomes in Study AI463520.		year 5	No