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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03281265
Enrollment
1178
Registered
2017-09-13
Start date
2012-01-01
Completion date
2017-02-28
Last updated
2018-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Failure, Acute on Chronic, Liver Injury

Keywords

pre-acute-on-chronic liver failure, hepatitis B

Brief summary

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.

Interventions

OTHERstandard treatment

Sponsors

Nanfang Hospital, Southern Medical University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years

Inclusion criteria

1. Chronic hepatitis B virus infection; 2. 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

1. Previous decompensation; 2. those who had hepatocellular carcinoma or other types of malignancies; 3. those who combined with severe chronic extra-hepatic disease; 4. pregnant; 5. received liver transplantation or kidney transplantation before or after admission; 6. readmission; 7. death within 24 hours.

Design outcomes

Primary

MeasureTime frameDescription
28-day ACLF progression28-dayprogressed to EASL defined ACLF
28-day mortality28-daydeath within 28-day

Secondary

MeasureTime frameDescription
90-day mortality90-daydeath within 90-day

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026