Hepatitis B, Chronic
Conditions
Keywords
Chronic Hepatitis B
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
Interventions
OTHERfollow-up
Sponsors
Bristol-Myers Squibb
Nanfang Hospital, Southern Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment patterns in Study AI463520 | 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. | year 5 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Outcome results
None listed