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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07815418

Enrollment

235

Registered

2026-09-11

Start date

2022-02-01

Completion date

2026-07-01

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

antiviral treatment, HBV-ACLF, prognosis

Brief 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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

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

Design outcomes

Primary

Measure	Time frame	Description
60-day survival rate of patients (%)	60 days	Survival status of patients 60 days after admission

Secondary

Measure	Time frame	Description
24-week HBV DNA negativity rate (%)	24 weeks	HBV DNA negative rate(%) at 24 weeks

Countries

China

Contacts

PRINCIPAL_INVESTIGATORMeifang Han, Doctor

Tongji Hospital

Outcome results