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CompletedNCT07815418Updated Sep 11, 2026

The Relationship Between Novel Virological Indicators and Treatment With Different Nucleotide Analogues and the Prognosis of HBV-ACLF Patients

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

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
235
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Acute-on-Chronic Liver Failure (ACLF)
  • hepatitisB
  • Treatment

Keywords

  • antiviral treatment
  • HBV-ACLF
  • prognosis
03

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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)

Inclusion criteria

  1. Age 18-70;
  2. Hepatitis B surface antigen positive ≥ 6 months;
  3. TBil>5mg/dl or 85 μ mol/L; INR ≥ 1.5 or PTA \< 40%; Clinical manifestation of ascites and/or hepatic encephalopathy within four weeks of onset (According to the diagnostic criteria recommended by the Asian Pacific association for the study of the liver (APASL))

Exclusion criteria

Exclusion Criteria:

  1. Patients with malignant liver tumors and other tumors;
  2. Pregnant or lactating women;
  3. Patients with liver diseases caused by combined hepatitis C virus infection, hepatitis E virus infection, autoimmune hepatitis, poisoning, drug-induced liver damage, acute variceal bleeding, alcoholic liver disease, and genetic metabolic liver disease;
  4. Patients with human immunodeficiency virus infection or other immunodeficiency diseases;
  5. Patients with other organ dysfunction or failure;
  6. Combined using more than one NAs drug
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
235 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • ETV group

    HBV-ACLF patients treated with ETV after admission

  • TAF group

    HBV-ACLF patients treated with TAF after admission

  • TMF group

    HBV-ACLF patients treated with TMF after admission

05

What researchers measure

Primary outcomes

  1. 60-day survival rate of patients (%)

    Survival status of patients 60 days after admission

    Time frame: 60 days

Secondary outcomes

  1. 24-week HBV DNA negativity rate (%)

    HBV DNA negative rate(%) at 24 weeks

    Time frame: 24 weeks

Other outcomes

  1. 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

06

Study locations

1 site
  • Tongji Hospital
    Wuhan, Hubei 430000, China
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07815418
Lead sponsor
Tongji Hospital
Responsible party
Meifang Han (Professor of Department of Infectious Diseases, Tongji Hospital) — Principal investigator
First posted
Sep 11, 2026
Start date
Feb 1, 2022
Primary completion
Apr 1, 2024
Completion
Jul 1, 2026
Last update
Sep 11, 2026

Study contacts

Meifang Han, Doctor
principal investigator · Tongji Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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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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