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NCT Number: NCT03920618

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

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.

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Key information

Conditions

Hepatitis B Acute-On-Chronic Liver Failure Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatic Insufficiency Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Liver Failure Liver Failure, Acute Virus Diseases

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location status: Recruiting

Location contact

Liang Peng, Doctor

CONTACT

[email protected]

+8613533978874

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Entecavir

Drug

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

Other names: Baraclude

Tenofovir disoproxil fumarate

Drug

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

Other names: Viread

Tenofovir alafenamide

Drug

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

Other names: Vemlidy

Primary outcomes

  1. Survival rate in the follow-up

    Time frame: 144 week

    Whether patients will survive after treatment is observed in the follow-up.

Secondary outcomes

  1. Model for end-stage liver disease (MELD) score is recorded after treatment

    Time frame: 0 week, 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week

    The calculation of model for end-stage liver disease (MELD) score is: R=0.378ln[serum total bilirubin (mg/dl)]+1.12ln(prothrombin time international normalized ratio)+0.95ln[serum creatinin(mg/dl)]+0.64. The higher the MELD score, the higher the mortality rate. MELD score is recorded after treatment.

  2. Ratio of patients with undetectable hepatitis b virus DNA after treatment

    Time frame: 4 week, 8 week, 12 week, 24 week, 48 week, 72 week,144 week

    Hepatitis b virus DNA would be tested to know the ratio of patients with undetectable hepatitis b virus DNA at 7 time points after treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Liang Peng, Doctor

CONTACT

[email protected]

+8613533978874

Wenxiong Xu, Doctor

CONTACT

[email protected]

+8613760783281

Sponsors and collaborators

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Other

Registry information

Official study title

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

Acronym: HBV

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2019
Registry last updated
Nov 29, 2024

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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