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Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF

Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF

Recruiting
12-65 years
All
Phase N/A

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Overview

This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV-related acute-on-chronic liver failure.

Description

Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate in China. Nucleotide/nucleoside analogues are used for anti-virus treatment in these patients. Entecavir, Tenofovir Disoproxil Fumarate and Tenofovir Alafenamide are first line drug in China. But there still lacks of data of Tenofovir Alafenamide in treatment of HBV related ACLF. This study is to investigate the clinical efficacy of three types of nucleotide/nucleoside analogues in treatment of HBV related ACLF.

Eligibility

Inclusion Criteria:

  1. Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
  2. Age from 12 to 65 years old;
  3. Serum total bilirubin level > 10 times upper limit of normal;
  4. Prothrombin time activity < 40% or prothrombin time international ratio > 1.5;
  5. Do not receive nucleotide/nucleoside analogues treatment in the past half year.

Exclusion Criteria:

  1. Other active liver diseases;
  2. Hepatocellular carcinoma or other malignancy;
  3. Pregnancy or lactation;
  4. Human immunodeficiency virus infection or congenital immune deficiency diseases;
  5. Severe diabetes, autoimmune diseases;
  6. Other important organ dysfunctions;
  7. Using glucocorticoid;
  8. Patients can not follow-up;
  9. Investigator considering inappropriate.

Study details
    Hepatitis B
    Acute-On-Chronic Liver Failure

NCT03920618

Third Affiliated Hospital, Sun Yat-Sen University

21 October 2025

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