REALM China Extension Study

• Conditions: Hepatitis B, Chronic

• Registration Number: NCT02974829
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Status Verified: 2016-11
• Study First Submitted: 2016-11-23
• Study First Submitted QC: 2016-11-23
• Last Update Submitted: 2016-11-23
• Study First Posted: 2016-11-29
• Last Update Posted: 2016-11-29
• Primary Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
Treatment patterns in Study AI463520	year 5

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (50)

First Affiliated Hospital of Anhui Medical University; 🇨🇳 Hefei, Anhui, China

302 Military Hospital Of China; 🇨🇳 Beijing, Beijing, China

Beijing Ditan Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China

People's Hospital of Beijing University; 🇨🇳 Beijing, Beijing, China

The Second Affiliated of ChongQing University of Medical Science; 🇨🇳 Chongqing, Chongqing, 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

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