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

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

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 type: Observational
• Enrollment: 4500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Academic / other)
• Locations: 5 sites (Changzhou, Jiangsu and 4 other locations)
• Trial ID: NCT05661786 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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

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 performed: 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.

Eligibility 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 this trial is running

Changzhou, Jiangsu and 4 other locations

• 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

• Study coordinator: Chao Wu, M.D., Ph.D

Conditions Chronic Hepatitis b; Chronic hepatitis b; Indeterminate phase; hepatitis B surface antigen clearance; Hepatocellular carcinoma; Antiviral treatment