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

Hepatitis B Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05117541
• Other study ID #: 21F.415
• Status: Active, not recruiting
• Start date: August 2, 2021
• Est. completion date: March 30, 2026

Study information

• Verified date: November 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 365
• Est. completion date: March 30, 2026
• Est. primary completion date: March 30, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Disease Progression
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B Infection
• Infections
• Liver Diseases

Intervention

Other:
• Interview
Participate in interviews

Procedure:
• Biospecimen Collection
Undergo collection of hair samples

Other:
• Electronic Health Record Review
Medical records are reviewed

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels		Baseline to 10 years