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Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Summary
Chronic hepatitis B virus (HBV) infection remains a global public health burden around the world. Investigating the disease process of chronic hepatitis B (CHB) is essential to individual management in clinical practice. According to American Association for the Study of Liver Diseases (AASLD) 2018 Hepatitis B Guidance, CHB can be classified into four phases: immune-tolerant CHB, HBeAg-positive immune active CHB, inactive CHB and hepatitis B e antigen (HBeAg)-negative immune active CHB. Antiviral therapy is recommended in patients with HBeAg-positive or -negative immune active CHB patients to reduce the incidence of liver cirrhosis and hepatocellular carcinoma, while periodic monitoring is recommended for inactive carrier and immune-tolerant CHB patients. However, a substantial proportion of patients fall into an indeterminate phase whose serum HBV DNA and alanine aminotransferase levels do not fit well into these well-described phases. Most of CHB patients with indeterminate phase are HBeAg negative. However, the clinical outcomes of these patients remain unclear. Therefore, the purpose of this study is to investigate the clinical outcomes of HBeAg-negative chronic hepatitis B patients with indeterminate phase.
Official title: Clinical Outcomes of HBeAg-negative Chronic Hepatitis B Patients With Indeterminate Phase: a Multi-center, Prospective, Observational Cohort Study (PILOT)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
4500
Start Date
2022-12
Completion Date
2028-05
Last Updated
2022-12-22
Healthy Volunteers
No
Conditions
Interventions
Observation
Monitor every 6 months
Antiviral treatment
Receive first-line antiviral treatment, including entecavir, tenofovir disoproxil fumarate, tenofovir alafenamide, tenofovir amibufenamide or peginterferon
Locations (5)
The Third Hospital of Changzhou
Changzhou, Jiangsu, China
Huai'an No.4 People's Hospital
Huai'an, Jiangsu, China
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Suqian People's Hospital
Suqian, Jiangsu, China
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu, China