RecruitingNot ApplicableNCT03920618

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

Study on Three Types of Nucleotide/Nucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure


Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Enrollment

150 participants

Start Date

Feb 21, 2019

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 12 YearsMax Age: 65 Years

Inclusion Criteria5

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

Exclusion Criteria9

  • Other active liver diseases;
  • Hepatocellular carcinoma or other malignancy;
  • Pregnancy or lactation;
  • Human immunodeficiency virus infection or congenital immune deficiency diseases;
  • Severe diabetes, autoimmune diseases;
  • Other important organ dysfunctions;
  • Using glucocorticoid;
  • Patients can not follow-up;
  • Investigator considering inappropriate.

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Interventions

DRUGEntecavir

Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.

DRUGTenofovir Disoproxil Fumarate

Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.

DRUGTenofovir Alafenamide

Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.


Locations(1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT03920618


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