NCT03281265

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,178

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
Last Updated

January 23, 2018

Status Verified

July 1, 2017

Enrollment Period

5.2 years

First QC Date

September 11, 2017

Last Update Submit

January 19, 2018

Conditions

Liver Failure, Acute on ChronicLiver Injury

Keywords

pre-acute-on-chronic liver failurehepatitis B

Outcome Measures

Primary Outcomes (2)

  • 28-day ACLF progression

    progressed to EASL defined ACLF

    28-day

  • 28-day mortality

    death within 28-day

    28-day

Secondary Outcomes (1)

  • 90-day mortality

    90-day

Interventions

standard treatmentOTHER

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with HBV-related compensated liver disease and acute liver injury or decompensation.

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute-On-Chronic Liver FailureHepatitis B

Condition Hierarchy (Ancestors)

Liver Failure, AcuteLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

January 1, 2012

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

January 23, 2018

Record last verified: 2017-07