Prognostic Relevance of Fatty Liver Disease for Patients With Chronic Hepatitis B
Conditions: Fatty Liver, Chronic Hepatitis b
Sponsor: Mahidol University

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Cover Page: 
 
Study Title: Prognostic Relevance of Fatty Liver Disease for Patients with Chronic Hepatitis B 
Short Title: Steatohepatitis in Chronic Hepatitis B 
 
Date: December 31st, 2021.  
NCT number: not available. 
    
 
 
 
 
 
 
 
 
 
 
 
 
 

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Study Protocol: 
 
Project title: Prognostic Relevance of Fatty Liver Disease for Patients with Chronic Hepatitis B 
 
Project summary: Fatty liver disease is increasingly recognized in patients with chronic hepatitis 
B (CHB). Whether concurrent fatty liver disease affects the long-term outcomes of CHB is unclear. 
The investigators will perform a longitudinal study to investigate the prognostic relevance of 
concurrent fatty liver disease for patients with CHB receiving antiviral therapy. 
 
Project description:  
Rationale: Fatty liver disease has become more prevalent in individuals with CHB, owing to the 
obesity epidemic. The coexistence of CHB and fatty liver disease, particularly the histologic 
phenotype of steatohepatitis, can augment liver damage and increase the risk of liver fibrosis. 
However, there are limited data on the impact of fatty liver disease on clinical outcomes (e.g., 
cirrhotic complications, hepatocellular carcinoma, need for liver transplantation, and all-cause 
death) during comprehensive treatment for CHB. 
 
Objectives: To determine the long-term effect of concurrent fatty liver disease, particularly a 
histologic phenotype of steatohepatitis on all-cause mortality and liver-related complications in 
patients with CHB receiving antiviral therapy at the Faculty of Medicine Siriraj Hospital, Mahidol 
University, Bangkok, Thailand. 
 
Methodology: Retrospective analysis of a prospectively collected database of 408 patients with 
chronic HBV infection who underwent a liver biopsy for therapeutic decision in initiating antiviral 
therapy between 2002 and 2008 at Siriraj Hospital, Bangkok, Thailand. 
 
Data management and analysis: Prospectively generated liver database that collates clinical, 
biochemical, and pathological data regarding chronic HBV infection and fatty liver disease. In 
addition, associated serological results, radiological reports, and patient follow-up/outcomes will 

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be also reported. Variables will be documented from the date of liver biopsy until either the study 
outcomes (death, liver transplantation, or liver-related complications), loss of follow-up, or the 
end of the study period.  
Statistical analyses will be done using SPSS version 18.0. Quantitative variables will be compared 
between groups using standard parametric or non-parametric tests, and qualitative variables will 
be compared using the Chi-squared test. The cumulative probabilities of mortality or liver 
transplantation and liver-related complications will be estimated by the Kaplan-Meier method 
and compared by the log-rank test. Hazard ratios and 95% confidence interval estimates for the 
outcomes will be calculated by Cox proportional hazard models.  
 
Ethical considerations: This study is approved by the Institutional Review Board and is conducted 
in accordance with the Declaration of Helsinki. 
 
Gender issues: None 
 
References 
 
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