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New treatment criteria for chronic hepatitis B without considering alanine aminotransferase levels to prevent hepatocellular carcinoma

New treatment criteria for chronic hepatitis B without considering alanine aminotransferase levels to prevent hepatocellular carcinoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0006879
Enrollment
15000
Registered
2021-12-30
Start date
2021-12-20
Completion date
Unknown
Last updated
2022-01-11

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

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Untreated CHB Patient Cohort 1) Adult male or female patients over 20 years of age. 2) Having serum hepatitis B surface antigens for >6 months 3) Never having any evidence of liver cirrhosis, radiologically, clinically, or both. 4) Serum ALT levels at baseline 6 months. 3) Never having any evidence of liver cirrhosis, radiologically, clinically, or both. 4) Having started HBV treatment with entecavir or tenofovir.

Exclusion criteria

Exclusion criteria: 1. Untreated CHB Patient Cohort 1) Patients with evidence of HCV infection, HDV infection or HIV infection. 2) Patients with prior antiviral treatment, malignancy, or immunosuppressive agents. 3) Insufficient medical records. 4) Patients with ALT levels at baseline >1× ULN and HBV DNA 2× ULN during the initial 1 year of follow-up. 7) Patients who were followed up less than a year. 2.Treated CHB Patient Cohort 1) Patients with evidence of HCV infection, HDV infection, or HIV infection. 2) Patients with prior antiviral treatment, malignancy, or immunosuppressive agents. 3) Insufficient medical records. 4) Patients who have received a liver transplantation or have history or evidence of HCC. 5) Patients who were followed up less than a year.

Design outcomes

Primary

MeasureTime frame
HCC occurrence rate by baseline HBV DNA levels

Secondary

MeasureTime frame
HCC occurrence rate by baseline HBV DNA levels in untreated non-cirrhotic CHB patients;HCC occurrence rate by baseline HBV DNA levels in treated non-cirrhotic CHB patients

Countries

Korea, Republic of

Contacts

Public ContactGi-Ae Kim

KyungHee University Medical Center

antiankle@hanmail.net+82-2-958-1665

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026