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Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase

Recruitingn/aAges 18 Years - anyAllThe Affiliated Nanjing Drum Tower Hospital of Nan…
NCT05661786 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Observation
  • Antiviral treatment
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Where

5 sites
The Third Hospital of Changzhou
Changzhou, China
Huai'an No.4 People's Hospital
Huai'an, China
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
Suqian People's Hospital
Suqian, China
The Fifth People's Hospital of Suzhou
Suzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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