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

NCT05117541 | Completed

• 3 other identifiers: 21F.415JT 17047R01DK125541
• Study Type: observational
• Target: 365
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Viral Hepatitis; Hepatitis B Infection

Outcome Measures

Primary Outcomes (2)

• 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

  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).

  At end of treatment

Secondary Outcomes (1)

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

  Baseline to 10 years

Study Arms (1)

Observational (interview, biospecimen collection)

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

Interventions

Interview OTHER

Participate in interviews

Observational (interview, biospecimen collection)

Biospecimen Collection PROCEDURE

Undergo collection of hair samples

Observational (interview, biospecimen collection)

Electronic Health Record Review OTHER

Medical records are reviewed

Observational (interview, biospecimen collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Hee-Soon Juon, PhD

  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: November 11, 2021
• Study Start: August 2, 2021
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (1)