<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03281265</url>
  </required_header>
  <id_info>
    <org_study_id>002</org_study_id>
    <nct_id>NCT03281265</nct_id>
  </id_info>
  <brief_title>A Retrospective Multicenter Study of HBV-related Pre-acute-on-chronic Liver Failure in China</brief_title>
  <official_title>A Retrospective Multicenter Study of HBV-related Pre-acute-on-chronic Liver Failure in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nanfang Hospital, Southern Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The definition and diagnostic criteria of Acute-on-chronic liver failure (ACLF) has been well&#xD;
      established by EASL CANONIC study. However, patients with high risk to develop ACLF has not&#xD;
      been determined, yet. The aim of current study is to establish a preliminary pre-ACLF&#xD;
      definition, and to demonstrate the corresponding risk factors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Actual">February 28, 2017</completion_date>
  <primary_completion_date type="Actual">February 28, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>28-day ACLF progression</measure>
    <time_frame>28-day</time_frame>
    <description>progressed to EASL defined ACLF</description>
  </primary_outcome>
  <primary_outcome>
    <measure>28-day mortality</measure>
    <time_frame>28-day</time_frame>
    <description>death within 28-day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>90-day mortality</measure>
    <time_frame>90-day</time_frame>
    <description>death within 90-day</description>
  </secondary_outcome>
  <enrollment type="Actual">1178</enrollment>
  <condition>Liver Failure, Acute on Chronic</condition>
  <condition>Liver Injury</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard treatment</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with HBV-related compensated liver disease and acute liver injury or&#xD;
        decompensation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Chronic hepatitis B virus infection;&#xD;
&#xD;
          2. Any of the followings: Alanine aminotransferase (ALT)≥3 upper limit of laboratory&#xD;
             reference (ULN); Aspartate aminotransferase (AST)≥3 ULN; Serum bilirubin≥2 ULN; Acute&#xD;
             decompensation (ascites, hepatic encephalopathy, variceal hemorrhage and/or bacterial&#xD;
             infections)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous decompensation;&#xD;
&#xD;
          2. those who had hepatocellular carcinoma or other types of malignancies;&#xD;
&#xD;
          3. those who combined with severe chronic extra-hepatic disease;&#xD;
&#xD;
          4. pregnant;&#xD;
&#xD;
          5. received liver transplantation or kidney transplantation before or after admission;&#xD;
&#xD;
          6. readmission;&#xD;
&#xD;
          7. death within 24 hours.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>January 19, 2018</last_update_submitted>
  <last_update_submitted_qc>January 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pre-acute-on-chronic liver failure</keyword>
  <keyword>hepatitis B</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Failure</mesh_term>
    <mesh_term>Hepatic Insufficiency</mesh_term>
    <mesh_term>End Stage Liver Disease</mesh_term>
    <mesh_term>Acute-On-Chronic Liver Failure</mesh_term>
    <mesh_term>Liver Failure, Acute</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03281265
org study id: 002
nct id: NCT03281265
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
observational model: Cohort
time perspective: Retrospective
measure: 28-day ACLF progression
time frame: 28-day
description: progressed to EASL defined ACLF
measure: 28-day mortality
time frame: 28-day
description: death within 28-day
measure: 90-day mortality
time frame: 90-day
description: death within 90-day
intervention type: Other
intervention name: standard treatment
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
responsible party type: Sponsor
mesh term: Liver Failure
mesh term: Hepatic Insufficiency
mesh term: End Stage Liver Disease
mesh term: Acute-On-Chronic Liver Failure
mesh term: Liver Failure, Acute
sharing ipd: Undecided