An observational study in Chronic Viral Hepatitis and Hepatitis B Infection, sponsored by Thomas Jefferson University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Thomas Jefferson University · Observational
This study explores how psychosocial factors (e.g., chronic stress, depression) may lead to liver disease progression such as liver cirrhosis or liver cancer among Korean American chronic hepatitis B infection patients. Gathering health information over time from Korean Americans with chronic hepatitis B infection may help doctors find better methods of treatment and on-going care.
PRIMARY OBJECTIVES:
I. To estimate the prevalence of chronic hepatitis B (CHB) phenotype and liver disease severity at enrollment visit, and model how multiple social-environmental, psychosocial, behavioral, clinical and biological attributes are associated with variation in CHB phenotype and disease severity.
II. To identify how these same attributes are associated with disease progression over time.
SECONDARY OBJECTIVE:
I. To examine the moderating effects of these multi-level factors on the relationship between liver disease progression and adverse liver disease outcome (e.g., hepatocellular carcinoma [HCC]), as well as mediating effects of liver disease progression on the relationship between psychosocial factors and liver cancer or death.
EXPLORATORY OBJECTIVE:
I. Using an explanatory mixed methods approach, to understand the care-seeking behaviors, and dynamics of care, within an ethnically concordant liver disease care model, and how these factors may have both direct and mediational effects on adherence, treatment effectiveness, and adverse disease outcomes.
OUTLINE:
Patients participate in interviews over 20-40 minutes and undergo collection of hair samples at baseline and 18-24 months. Patients' medical records are also reviewed.
1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.
This study's enrollment of 365 is close to the median of 390 across 407 observational studies indexed under Hepatitis B.
Browse Hepatitis B studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Korean American patients with chronic hepatitis B infection at Liver Disease Prevention Center, Thomas Jefferson University Hospital (TJUH) or Asian Pacific Liver Center (APLC), Coalition of Inclusive Medicine
Exclusion Criteria:
Patients participate in interviews over 20-40 minutes and undergo collection of hair samples at baseline and 18-24 months. Patients' medical records are also reviewed.
Other: Interview · Procedure: Biospecimen Collection · Other: Electronic Health Record Review
Participate in interviews
Undergo collection of hair samples
Medical records are reviewed
Change Chronic hepatitis B (CHB) phenotype
Categorized as follows: 1) immune tolerant, 2) immune active with hepatitis B virus e antigen (HBeAg)(+), 3) immune active with HBeAg(-), and 4) inactive carrier, with patients not fitting into one of these four phenotypes classified as 5) indeterminant. Phenotype at study enrollment will be calculated
Time frame: At start of treatment
Change Liver disease severity
Will be estimated using fibrosis 4 (FIB-4) (a parameter calculated using alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\] values, platelet count and age) and APRI (AST to platelet ratios).
Time frame: At end of treatment
Change in hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels
Time frame: Baseline to 10 years
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Thomas Jefferson University