Clinical Outcomes of HBeAg-negative CHB Patients With Indeterminate Phase

Last updated: December 21, 2022
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis

Hepatitis B

Liver Disorders

Treatment

N/A

Clinical Study ID

NCT05661786
NJDTID-2201
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 liverstiffness >8 kilopascals (kPa)
  8. No family history of liver cirrhosis or hepatocellular carcinoma

Exclusion

Exclusion Criteria:

  1. Coinfection with hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis Evirus 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 heavydrinking 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, autoimmunediseases;
  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.

Study Design

Total Participants: 4500
Study Start date:
December 01, 2022
Estimated Completion Date:
May 31, 2028

Connect with a study center

  • The Third Hospital of Changzhou

    Changzhou, Jiangsu 213001
    China

    Active - Recruiting

  • Huai'an No.4 People's Hospital

    Huai'an, Jiangsu 223300
    China

    Active - Recruiting

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

  • Suqian People's Hospital

    Suqian, Jiangsu 223800
    China

    Active - Recruiting

  • The Fifth People's Hospital of Suzhou

    Suzhou, Jiangsu 215007
    China

    Active - Recruiting

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