Chronic Viral HepatitisNCT05117541
Social-environmental, Psychosocial, Behavioral, Clinical and Biological Drivers of Disparities in Liver Disease Progression Among Korean American With Chronic Hepatitis B Infection
An observational study of Chronic Viral Hepatitis and Hepatitis B Infection, run by Thomas Jefferson University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Viral Hepatitis, Hepatitis B Infection
- What is being tested?
- Interview, Biospecimen Collection and Electronic Health Record Review
- Type of treatment
- Surgery or procedure
- How many people
- 365 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2021to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Bio-psycho-social Drivers of Disparities in Liver Disease Progression Among Korean Americans With 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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.
- Conditions
- Chronic Viral Hepatitis, Hepatitis B Infection
- Being tested
- Interview, Biospecimen Collection, Electronic Health Record Review
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Participate in interviews
Biospecimen CollectionProcedure or surgery
Undergo collection of hair samples
Electronic Health Record ReviewOther
Medical records are reviewed
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Interview; Procedure: Biospecimen Collection; Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: At end of treatment
Secondary outcomes (1)
Change in hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels
Measured: Baseline to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start2 Aug 2021
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Viral HepatitisStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hee-Soon Juon, PhD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117541
- Sponsor's protocol ID
- 21F.415
- Other IDs
- JT 17047, R01DK125541
- Status last verified
- Apr 2026
- First submitted
- 21 Sep 2021
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bio-psycho-social Drivers of Disparities in Liver Disease Progression Among Korean Americans With Hepatitis B Infection
- ClinicalTrials.gov ID
- NCT05117541
- Acronym / sponsor ID
- 21F.415
- Conditions
- Chronic Viral Hepatitis, Hepatitis B Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 2 Aug 2021 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 11 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (interview, biospecimen collection) | – | Other: Interview, Procedure: Biospecimen Collection, Other: Electronic Health Record ReviewPatients 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewParticipate in interviews | Other | Observational (interview, biospecimen collection) |
| Biospecimen CollectionUndergo collection of hair samples | Procedure or surgery | Observational (interview, biospecimen collection) |
| Electronic Health Record ReviewMedical records are reviewed | Other | Observational (interview, biospecimen collection) |
Primary outcome
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
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).
1 secondary outcome
Change in hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels
Time frame: Baseline to 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hee-Soon Juon, PhD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Viral Hepatitis and Hepatitis B Infection, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Chronic hepatitis B (CHB) phenotype (time frame: At start of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.