RecruitingNCT05661786

Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase

Clinical Outcomes of HBeAg-negative Chronic Hepatitis B Patients With Indeterminate Phase: a Multi-center, Prospective, Observational Cohort Study (PILOT)


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

4,500 participants

Start Date

Dec 1, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study follows patients with a specific form of chronic hepatitis B infection — where the virus is active but liver tests look normal — to learn more about their long-term outcomes. The goal is to better understand when these patients might need treatment in the future. **You may be eligible if...** - You are 18 or older - You have had a positive hepatitis B surface antigen test for more than 6 months - You test negative for HBeAg (a viral marker) and positive for anti-HBe antibodies - Your hepatitis B viral load is above 2,000 IU/mL - Your liver enzyme levels (ALT) are consistently normal - Your liver inflammation and scarring are minimal (confirmed by biopsy or imaging) - You have never been treated for hepatitis B **You may NOT be eligible if...** - You have another hepatitis infection (A, C, D, or E) or HIV - You already have liver cirrhosis or liver cancer - You have a history of alcohol abuse or drug abuse - You are pregnant or planning pregnancy - You have uncontrolled diabetes, hypertension, or autoimmune disease - You have had an organ transplant or are being considered for one Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERObservation

Monitor every 6 months

OTHERAntiviral 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

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NCT05661786


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