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Completed

NCT Number: NCT03281265

A Retrospective Multicenter Study of HBV-related Pre-acute-on-chronic Liver Failure in China

The definition and diagnostic criteria of Acute-on-chronic liver failure (ACLF) has been well established by EASL CANONIC study. However, patients with high risk to develop ACLF has not been determined, yet. The aim of current study is to establish a preliminary pre-ACLF definition, and to demonstrate the corresponding risk factors.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

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

Inclusion criteria

  • Chronic hepatitis B virus infection;
  • Any of the followings: Alanine aminotransferase (ALT)≥3 upper limit of laboratory reference (ULN); Aspartate aminotransferase (AST)≥3 ULN; Serum bilirubin≥2 ULN; Acute decompensation (ascites, hepatic encephalopathy, variceal hemorrhage and/or bacterial infections)

Exclusion criteria

  • Previous decompensation;
  • those who had hepatocellular carcinoma or other types of malignancies;
  • those who combined with severe chronic extra-hepatic disease;
  • pregnant;
  • received liver transplantation or kidney transplantation before or after admission;
  • readmission;
  • death within 24 hours.

Treatment and study plan

standard treatment

Other

Primary outcomes

  1. 28-day ACLF progression

    Time frame: 28-day

    progressed to EASL defined ACLF

  2. 28-day mortality

    Time frame: 28-day

    death within 28-day

Secondary outcomes

  1. 90-day mortality

    Time frame: 90-day

    death within 90-day

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Sep 13, 2017
Registry last updated
Jan 23, 2018

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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