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

Not Applicable

Recruiting

• Conditions: Certain infectious and parasitic diseases

• Registration Number: KCT0006879
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 January 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15000

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 <2× upper limit of normal (ULN) [ULN of ALT =40 U/L]
5) Never having received HBV treatment, including nucleos(t)ide analogues.

2.Treated 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) Having started HBV treatment with entecavir or tenofovir.

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 <2,000 IU/mL.
5) Patients who have received a liver transplantation or have history or evidence of HCC.
6) Patients with ALT elevation >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.

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HCC occurrence rate by baseline HBV DNA levels

Secondary Outcome Measures

Name	Time	Method
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