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

NCT07815418 | Completed

• 1 other identifier: TJ-202403051
• Study Type: observational
• Target: 235
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

antiviral treatment; HBV-ACLF; prognosis

Outcome Measures

Primary Outcomes (1)

• 60-day survival rate of patients (%)

  Survival status of patients 60 days after admission

  60 days

Secondary Outcomes (1)

• 24-week HBV DNA negativity rate (%)

  24 weeks

Other Outcomes (1)

• Improvement of biochemistry and coagulation function at 2 weeks after admission

  2 weeks

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Age 18-70;
• Hepatitis B surface antigen positive ≥ 6 months;
• 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))

You may not qualify if:

• Patients with malignant liver tumors and other tumors;
• Pregnant or lactating women;
• 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;
• Patients with human immunodeficiency virus infection or other immunodeficiency diseases;
• Patients with other organ dysfunction or failure;
• Combined using more than one NAs drug

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430000, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Officials

• Meifang Han, Doctor

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Department of Infectious Diseases

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: February 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-08

Locations

CN (1)