An observational study in Acute-on-Chronic Liver Failure (ACLF), hepatitisB and Treatment, sponsored by Tongji Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Tongji Hospital · Observational
This is an observational study. This study mainly explores the dynamic changes of HBV RNA and HBcrAg during the treatment of HBV-ACLF, as well as the safety of entecavir (ETV), tenofovir alafenamide (TAF) and tenofovir amibufenamide (TMF) during the treatment process, and evaluates the differences in patient prognosis among the three drugs.
NAs drugs play an important role in the treatment of HBV-ACLF. Currently, multiple research results indicate that the use of NAs can significantly improve the prognosis of HBV-ACLF patients, and the rapid decrease in early viral load is closely related to better prognosis. Compared to ETV and TDF, two early marketed NAs drugs, there is limited research on the prognosis and safety of TAF and TMF in HBV-ACLF patients, and head to head studies on the treatment of HBV-ACLF with various commonly used NAs drugs are even rarer. In addition, how novel virological markers change in HBV-ACLF patients after NAs treatment and whether there is a correlation with patient prognosis is also an unexplored topic. Therefore, this study aims to analyze the changes in clinical indicators and viral markers in HBV-ACLF patients during hospitalization, combined with the patient's prognosis, to explore the dynamic changes of novel virological markers during HBV-ACLF treatment, as well as the safety and impact of different NAs drugs on the prognosis of HBV-ACLF treatment.
The research population is CHB patients who have a diagnosis of ACLF according to the diagnostic criteria recommended by the Asian Pacific association for the study of the liver (APASL)
Exclusion Criteria:
HBV-ACLF patients treated with ETV after admission
HBV-ACLF patients treated with TAF after admission
HBV-ACLF patients treated with TMF after admission
60-day survival rate of patients (%)
Survival status of patients 60 days after admission
Time frame: 60 days
24-week HBV DNA negativity rate (%)
HBV DNA negative rate(%) at 24 weeks
Time frame: 24 weeks
Improvement of biochemistry and coagulation function at 2 weeks after admission
Changes in biochemistry and coagulation function of the patients at 2 weeks after admission.
Time frame: 2 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Acute-On-Chronic Liver Failure→
Tongji Hospital