Outcomes of HBeAg-Negative Chronic Hepatitis B Patients With Indeterminate Phase A Multi-Center Prospective Observational Study

What this Trial Is About

Chronic hepatitis B virus HBV infection is a significant global health concern. Researchers are investigating the clinical outcomes of patients with chronic hepatitis B CHB who are negative for hepatitis B e antigen HBeAg and fall into an indeterminate phase, meaning their blood test results do not clearly fit into the usual CHB phases. This study aims to understand the health progression of these patients, whose outcomes are not well known, which can help improve individual patient management. Participants are divided into two groups one group will be observed with regular monitoring every six months, and the other group will receive first-line antiviral treatments such as entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide, tenofovir amibufenamide, or peginterferon. The study is a prospective, observational cohort design conducted across multiple centers, aiming to follow patients over a long period. During the study, participants will have regular assessments to track key outcomes including the occurrence of liver cancer hepatocellular carcinoma and the clearance rate of hepatitis B surface antigen HBsAg over 240 weeks about 4.5 years. Researchers will monitor liver health, viral levels, and other clinical markers to understand disease progression. The study is led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School and will continue until May 2028.

Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase