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Study identifier: NCT05661786 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase

Condition: Chronic Hepatitis b  ·  Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

PhaseN/A
Planned participants4500
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Chao Wu, M.D., Ph.D  ·  86-25-83105890  ·  dr.wu@nju.edu.cn

Rui Huang, M.D., Ph.D  ·  doctor_hr@126.com

Always discuss trial participation with your own doctor first.

Locations (5)

The Third Hospital of ChangzhouChangzhou, Jiangsu, ChinaRecruiting
Huai'an No.4 People's HospitalHuai'an, Jiangsu, ChinaRecruiting
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical SchoolNanjing, Jiangsu, ChinaRecruiting
Suqian People's HospitalSuqian, Jiangsu, ChinaRecruiting
The Fifth People's Hospital of SuzhouSuzhou, Jiangsu, ChinaRecruiting

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Source record: clinicaltrials.gov/study/NCT05661786