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Completed

NCT Number: NCT07815418

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tongji Hospital

Wuhan, Hubei, 430000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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))

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 60 days

    Survival status of patients 60 days after admission

Secondary outcomes

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

    Time frame: 24 weeks

    HBV DNA negative rate(%) at 24 weeks

Other outcomes

  1. Improvement of biochemistry and coagulation function at 2 weeks after admission

    Time frame: 2 weeks

    Changes in biochemistry and coagulation function of the patients at 2 weeks after admission.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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