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.
Humans
Hepatitis B virus
/ genetics
Alanine Transaminase
/ blood
Antiviral Agents
/ therapeutic use
Hepatitis B, Chronic
/ drug therapy
DNA, Viral
/ blood
Randomized Controlled Trials as Topic
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
Antiviral treatment
Chronic hepatitis B
Negative HBeAg
Normal ALT
Randomized controlled trial
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
03 Oct 2024
03 Oct 2024
Historique:
received:
30
10
2023
accepted:
27
08
2024
medline:
4
10
2024
pubmed:
4
10
2024
entrez:
3
10
2024
Statut:
epublish
Résumé
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. 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. 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. This trial was registered with the Chinese Clinical Trial Registry (ChiCTR2300069391) on 15 March 2023.
Sections du résumé
BACKGROUND
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
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
CONCLUSIONS
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
BACKGROUND
This trial was registered with the Chinese Clinical Trial Registry (ChiCTR2300069391) on 15 March 2023.
Identifiants
pubmed: 39363218
doi: 10.1186/s13063-024-08433-x
pii: 10.1186/s13063-024-08433-x
doi:
Substances chimiques
Alanine Transaminase
EC 2.6.1.2
Antiviral Agents
0
DNA, Viral
0
Hepatitis B e Antigens
0
Biomarkers
0
Nucleosides
0
Types de publication
Journal Article
Clinical Trial Protocol
Langues
eng
Sous-ensembles de citation
IM
Pagination
652Informations de copyright
© 2024. The Author(s).
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