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

Liver Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03281265
• Other study ID #: 002
• Status: Completed
• Phase: N/A
• First received: September 11, 2017
• Last updated: January 19, 2018
• Start date: January 1, 2012
• Est. completion date: February 28, 2017

Study information

• Verified date: July 2017
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1178
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Liver Failure
• Liver Failure, Acute
• Liver Failure, Acute on Chronic
• Liver Injury

Intervention

Other:
• standard treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day ACLF progression	progressed to EASL defined ACLF	28-day
Primary	28-day mortality	death within 28-day	28-day
Secondary	90-day mortality	death within 90-day	90-day