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

Last updated: November 26, 2024
Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatitis

Liver Disorders

Primary Biliary Cholangitis

Treatment

Tenofovir Alafenamide

Entecavir

Tenofovir Disoproxil Fumarate

Clinical Study ID

NCT03920618
PL6
  • Ages 12-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: Tenofovir Alafenamide
Phase:
Study Start date:
February 21, 2019
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Third Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong 510630
    China

    Active - Recruiting

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