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Quality of Life in Chronic Hepatitis B Patients Who May Need Treatment Compared With Inactive Patients

Health-Related Quality of Life and Psychological Status in Potential Treatment Candidates and Inactive Chronic Hepatitis B Patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0011585
Enrollment
360
Registered
2026-02-06
Start date
2026-02-16
Completion date
Unknown
Last updated
2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Inje University Haeundae Paik Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults who voluntarily provide written informed consent 2. Patients with chronic hepatitis B confirmed by hepatitis B surface antigen positivity for at least six months 3. Patients who have not received prior antiviral therapy and do not currently meet standard treatment criteria 4. Patients classified as immune-tolerant, HBeAg-positive grey-zone, HBeAg-negative grey-zone, or inactive chronic hepatitis B

Exclusion criteria

Exclusion criteria: 1. Current or previous treatment with antiviral therapy for hepatitis B 2. History of hepatocellular carcinoma 3. History of other malignancies with complete remission for less than one year 4. Decompensated liver cirrhosis, including ascites, variceal bleeding, or hepatic encephalopathy, or Child–Pugh class B or C 5. Concomitant infection with hepatitis C virus (anti-HCV positive or HCV RNA positive) or human immunodeficiency virus 6. History of liver transplantation 7. Significant alcohol consumption defined as =60 g/day for men or =40 g/day for women, or a diagnosis of alcoholic liver disease 8. Unstable or inadequately controlled severe psychiatric disorders, such as major depressive disorder or anxiety disorder 9. Women who are currently pregnant

Design outcomes

Primary

MeasureTime frame
Health-related quality of life assessed using the Chronic Liver Disease Questionnaire (CLDQ) in patients with chronic hepatitis B

Secondary

MeasureTime frame
Levels of depression, anxiety, and psychological stress assessed using standardized questionnaires in patients with chronic hepatitis B;Association between clinical parameters and patient-reported outcomes

Countries

Korea, Republic of

Contacts

Public ContactNae-Yun Heo

Inje University Haeundae Paik Hospital

nyheo@hanmail.net+82-51-797-2436

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 15, 2026