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Completed

NCT Number: NCT05117541

Social-environmental, Psychosocial, Behavioral, Clinical and Biological Drivers of Disparities in Liver Disease Progression Among Korean American With Chronic Hepatitis B Infection

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provide signed and dated informed consent form
  • Willing to comply with all study procedures and be available for the duration of the study
  • Korean-American male or female, age over 18 and older
  • CHB Patients who have lab and medical record data (including hepatitis B virus [HBV] deoxyribonucleic acid [DNA] viral load, hepatitis B virus e Antigen [HBeAg] status, and liver enzyme values) exist from 2015 or before

Exclusion criteria

  • Patients who have received a diagnosis of HCC, although they may have been diagnosed with cirrhosis
  • Patients who have been diagnosed with other viral infections (hepatitis C virus [HCV], human immunodeficiency virus [HIV], etc.)
  • Patients who have total baldness

Treatment and study plan

interview

Other

Participate in interviews

Biospecimen Collection

Procedure

Undergo collection of hair samples

Electronic Health Record Review

Other

Medical records are reviewed

Primary outcomes

  1. Change Chronic hepatitis B (CHB) phenotype

    Time frame: At start of treatment

    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

  2. Change Liver disease severity

    Time frame: At end of treatment

    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).

Secondary outcomes

  1. Change in hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels

    Time frame: Baseline to 10 years

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Bio-psycho-social Drivers of Disparities in Liver Disease Progression Among Korean Americans With Hepatitis B Infection

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 11, 2021
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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