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Clinical trial Recruiting at 5 sites Observational Ages 18 and up

Observing outcomes in patients with chronic hepatitis B in an indeterminate phase

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

Run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · NCT05661786 · Data updated 2026-11-12

This study is trying to learn more about patients with chronic hepatitis B who are in a tricky stage of their illness to see how their condition changes and if they might need treatment.

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment4500 (estimated)
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Academic / other
Locations5 sites (Changzhou, Jiangsu and 4 other locations)
StatusRecruiting
StartedDecember 2022
Main results expectedFebruary 2028
Study endsMay 2028
Registry record updatedDecember 22, 2022
Trial IDNCT05661786 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are treatment-naïve adults aged 18 and older who are HBeAg-negative and have specific HBV DNA and ALT levels.

Probably not a fit

Patients with coexisting liver diseases, cirrhosis, or those with a history of substance abuse may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients with chronic hepatitis B (CHB) who are HBeAg-negative and fall into an indeterminate phase, where their HBV DNA and alanine aminotransferase levels do not clearly fit into established classifications. The study aims to monitor these patients to better understand their disease progression and the potential need for antiviral treatment. By analyzing the clinical outcomes of this specific patient group, the research seeks to improve individual management strategies for chronic hepatitis B. The study will include treatment-naïve patients who meet specific eligibility criteria, ensuring a focused approach to this under-researched phase of CHB.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for patients with chronic hepatitis B in the indeterminate phase, potentially reducing the risk of liver complications.

How similar studies have gone: While there is limited research specifically on the indeterminate phase of chronic hepatitis B, studies on other phases of CHB have shown promising results with antiviral treatments.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Hepatitis B surface antigen (HBsAg) positive over 6 months
2. Age ≥18 years
3. Treatment-naïve
4. HBeAg negative, anti-HBe positive
5. HBV DNA \>2000 IU/mL
6. Persistently normal alanine transaminase (ALT)
7. Liver inflammation \<G2 or A2 and liver fibrosis \<S2 or F2 before enrollment, or liver stiffness \>8 kilopascals (kPa)
8. No family history of liver cirrhosis or hepatocellular carcinoma

Exclusion Criteria:

1. Coinfection with hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus or human immunodeficiency virus;
2. Coexisting of hepatocellular carcinoma and other malignancy, or alpha-fetoprotein \>upper limit of normal at enrollment;
3. Presence of liver cirrhosis;
4. Alcohol abuse within the last year (ethanol: male \>40 g/d, female \>20 g/d; or heavy drinking within 2 weeks before enrollment: ethanol \>80 g/d), or history of drug abuse;
5. Participating in other clinical trials in the last 3 months;
6. Coexisting of autoimmune liver diseases;
7. Pregnant or planned pregnancy in a short term or lactation patients;
8. History of severe heart disease, mental disease;
9. Uncontrolled diabetes, hypertension, thyroid dysfunction, retinopathy, autoimmune diseases;
10. Neutrophil count \<2×10\^9/L and/or platelet count \<100×10\^9/L;
11. History of organ transplantation or preparing for organ transplantation;
12. Using immunosuppressive drugs;
13. Undergone organ transplantation or preparing for organ transplantation;
14. Receiving immunosuppressive agents;
15. Patients thought by the investigators not suitable to participate in this study.

Where it's running

  • The Third Hospital of Changzhou
    Changzhou, Jiangsu, China     Recruiting
  • Huai'an No.4 People's Hospital
    Huai'an, Jiangsu, China     Recruiting
  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
    Nanjing, Jiangsu, China     Recruiting
  • Suqian People's Hospital
    Suqian, Jiangsu, China     Recruiting
  • The Fifth People's Hospital of Suzhou
    Suzhou, Jiangsu, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Chronic Hepatitis B 56The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 59
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.