Nucleos(t)ide analogs to treat patients with positive hepatitis B virus deoxyribonucleic acid and normal alanine transaminase: protocol for an open-label single-center randomized parallel controlled trial.

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  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
    • Publication Information:
      Original Publication: [London] : BioMed Central, 2006-
    • Subject Terms:
      Hepatitis B virus*/genetics ; Hepatitis B virus*/drug effects ; Alanine Transaminase*/blood ; Antiviral Agents*/therapeutic use ; Antiviral Agents*/adverse effects ; Hepatitis B, Chronic*/drug therapy ; Hepatitis B, Chronic*/virology ; Hepatitis B, Chronic*/blood ; DNA, Viral*/blood ; Randomized Controlled Trials as Topic*; Humans ; Adult ; Treatment Outcome ; China ; Quality of Life ; Male ; Middle Aged ; Female ; Hepatitis B e Antigens/blood ; Young Adult ; Biomarkers/blood ; Nucleosides/therapeutic use ; Time Factors ; Viral Load
    • Abstract:
      Background: Direct high-quality evidence remains absent on the benefits of HBeAg-negative chronic hepatitis B patients (CHB) with normal alanine transaminase (ALT) and positive HBV DNA after nucleos(t)ide analogs (NAs) treatment.
      Methods: This is a single-center, open-label, randomized parallel controlled trial with a follow-up duration of 96 weeks. An estimated 300 patients will be recruited at West China Hospital of Sichuan University, China. After stratified by serum HBV DNA (< 2000 vs. ≥ 2000 IU/ml), eligible patients will be randomized (allocation ratio 1:1) to receive either antiviral therapy (the treatment group) or regular examination alone (the control group). The primary outcomes are rates of virological response and changes in the levels of serum HBV pregenomic RNA (pgRNA) and scores of health-related qualities of life.
      Discussion: This randomized controlled trial focuses on HBeAg-negative patients with normal ALT, including those of the inactive carrier phase and the grey zone, whose antiviral treatment remains controversial. Additionally, a health-related quality of life scale is introduced to comprehensively estimate the benefit of antiviral treatment apart from virological response and adverse liver events. Meaningfully, the study findings will provide high-quality and direct evidence for optimal clinical management in such populations.
      Trial Registration: This trial was registered with the Chinese Clinical Trial Registry (ChiCTR2300069391) on 15 March 2023.
      (© 2024. The Author(s).)
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    • Contributed Indexing:
      Keywords: Antiviral treatment; Chronic hepatitis B; Negative HBeAg; Normal ALT; Randomized controlled trial
    • Accession Number:
      EC 2.6.1.2 (Alanine Transaminase)
      0 (Antiviral Agents)
      0 (DNA, Viral)
      0 (Hepatitis B e Antigens)
      0 (Biomarkers)
      0 (Nucleosides)
    • Publication Date:
      Date Created: 20241003 Date Completed: 20241004 Latest Revision: 20241006
    • Publication Date:
      20241006
    • Accession Number:
      PMC11448396
    • Accession Number:
      10.1186/s13063-024-08433-x
    • Accession Number:
      39363218