<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/NCT03754400</url>
  </required_header>
  <id_info>
    <org_study_id>ILBS-ACLF-02</org_study_id>
    <nct_id>NCT03754400</nct_id>
  </id_info>
  <brief_title>Efficacy of Albumin Therapy With Standard Medical Treatment (SMT) as Compared to Standard Medical Treatment (SMT) in Improving Patient Survival and Immune Modulation in Patients With Acute on Chronic Liver Failure (ASIA Trial).</brief_title>
  <official_title>A Randomized Controlled Trial of Efficacy of Albumin Therapy With Standard Medical Treatment (SMT) as Compared to Standard Medical Treatment (SMT) in Improving Patient Survival and Immune Modulation in Patients With Acute on Chronic Liver Failure (ASIA Trial).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institute of Liver and Biliary Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institute of Liver and Biliary Sciences, India</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The AIM of the study is to study the efficacy of intravenous albumin and standard medical&#xD;
      treatment as compared to standard medical treatment alone in ameliorating/preventing SIRS and&#xD;
      improving survival at 28 days .The project will be conducted in ILBS from august 2018 to&#xD;
      December 2019Concept is to understand the immunology, pathophysiology and effects of albumin&#xD;
      in the management of ACLF for betterment of the patient's condition and early recovery.&#xD;
&#xD;
      All ACLF patients will be included as per the inclusion and exclusion criteria , after taking&#xD;
      informed consent from the patient or their relatives. Will be evaluated for the possible risk&#xD;
      factors for the development of SIRS/sepsis in ACLF patients and possible beneficial factors&#xD;
      for resolution of SIRS /sepsis in ACLF patients. The effects of albumin administration as per&#xD;
      this protocol versus standard medical treatment alone will be reviewed If patient develops&#xD;
      allergic reactions to albumin, fluid overload, albumin will be stopped and patient will be&#xD;
      treated accordingly to medical condition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 10, 2018</start_date>
  <completion_date type="Anticipated">July 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Transplant free survival in both groups</measure>
    <time_frame>28 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Transplant free survival in both groups.</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence or resolution of infection in both groups</measure>
    <time_frame>7 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence or resolution of infection in both groups</measure>
    <time_frame>14 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence or resolution of infection in both groups</measure>
    <time_frame>28 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participant with development of new organ failure in both groups.</measure>
    <time_frame>7 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participant with development of new organ failure in both groups.</measure>
    <time_frame>14 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participant with development of new organ failure in both groups.</measure>
    <time_frame>28 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events in both groups.</measure>
    <time_frame>28 day</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Acute on Chronic Liver Failure</condition>
  <arm_group>
    <arm_group_label>Albumin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will receive a daily intravenous infusion of 20% Human Albumin Solution (HAS) 40 gram at day 0 (loading dose), Day-1 to day 7, 20 gm daily, then from day 8 to day 28, 20 gm every alternate day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Medical Treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Antibiotics, nutrition and supportive treatment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Albumin</intervention_name>
    <description>All patients will receive a daily intravenous infusion of 20% Human Albumin Solution (HAS) 40 gram at day 0 (loading dose), Day-1 to day 7, 20 gm daily, then from day 8 to day 28, 20 gm every alternate day.</description>
    <arm_group_label>Albumin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Medical Treatment</intervention_name>
    <description>Antibiotics, nutrition and supportive treatment</description>
    <arm_group_label>Albumin</arm_group_label>
    <arm_group_label>Standard Medical Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age &gt;18 years to 65 years&#xD;
&#xD;
          2. ACLF patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who have already received albumin in last 1 week&#xD;
&#xD;
          2. Patients who require albumin like PICD (Paracentesis-Induced Circulatory Dysfunction)&#xD;
&#xD;
             ,SBP (Spontaneous bacterial peritonitis),LVP(large volume&#xD;
             paracentesis),HRS(hepatorenal syndrome)&#xD;
&#xD;
          3. Not given consent&#xD;
&#xD;
          4. Significant cardiopulmonary or structural heart disease/ CKD(chronic kidney diseses)&#xD;
             /volume overload /upper GI bleed.&#xD;
&#xD;
          5. Pregnant/ HIV / HCC &gt;2cm size&#xD;
&#xD;
          6. Alcoholic hepatitis eligible for steroids&#xD;
&#xD;
          7. Previous known allergic/adverse reaction to albumin&#xD;
&#xD;
          8. Any clinical condition which the investigator considers would make the patient&#xD;
             unsuitable for the trial&#xD;
&#xD;
          9. Patients who will receive palliative treatment only during their hospital admission&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Dr Rakesh Jagdish, MD</last_name>
    <phone>01146300000</phone>
    <email>dr.rkj.kapil@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute of Liver &amp; Biliary Sciences</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110070</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>November 17, 2018</study_first_submitted>
  <study_first_submitted_qc>November 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>April 7, 2020</last_update_submitted>
  <last_update_submitted_qc>April 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  </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/NCT03754400
org study id: ILBS-ACLF-02
nct id: NCT03754400
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The AIM of the study is to study the efficacy of intravenous albumin and standard medical
      treatment as compared to standard medical treatment alone in ameliorating/preventing SIRS and
      improving survival at 28 days .The project will be conducted in ILBS from august 2018 to
      December 2019Concept is to understand the immunology, pathophysiology and effects of albumin
      in the management of ACLF for betterment of the patient's condition and early recovery.

      All ACLF patients will be included as per the inclusion and exclusion criteria , after taking
      informed consent from the patient or their relatives. Will be evaluated for the possible risk
      factors for the development of SIRS/sepsis in ACLF patients and possible beneficial factors
      for resolution of SIRS /sepsis in ACLF patients. The effects of albumin administration as per
      this protocol versus standard medical treatment alone will be reviewed If patient develops
      allergic reactions to albumin, fluid overload, albumin will be stopped and patient will be
      treated accordingly to medical condition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Transplant free survival in both groups
time frame: 28 days
measure: Transplant free survival in both groups.
time frame: 7 days
measure: Incidence or resolution of infection in both groups
time frame: 7 day
measure: Incidence or resolution of infection in both groups
time frame: 14 day
measure: Incidence or resolution of infection in both groups
time frame: 28 day
measure: Number of participant with development of new organ failure in both groups.
time frame: 7 day
measure: Number of participant with development of new organ failure in both groups.
time frame: 14 day
measure: Number of participant with development of new organ failure in both groups.
time frame: 28 day
measure: Adverse events in both groups.
time frame: 28 day
arm group label: Albumin
arm group type: Experimental
description: All patients will receive a daily intravenous infusion of 20% Human Albumin Solution (HAS) 40 gram at day 0 (loading dose), Day-1 to day 7, 20 gm daily, then from day 8 to day 28, 20 gm every alternate day.
arm group label: Standard Medical Treatment
arm group type: Active Comparator
description: Antibiotics, nutrition and supportive treatment.
intervention type: Biological
intervention name: Albumin
description: All patients will receive a daily intravenous infusion of 20% Human Albumin Solution (HAS) 40 gram at day 0 (loading dose), Day-1 to day 7, 20 gm daily, then from day 8 to day 28, 20 gm every alternate day.
arm group label: Albumin
intervention type: Other
intervention name: Standard Medical Treatment
description: Antibiotics, nutrition and supportive treatment
arm group label: Albumin
arm group label: Standard Medical Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Dr Rakesh Jagdish, MD
phone: 01146300000
email: dr.rkj.kapil@gmail.com
facility: 
status: Recruiting
country: India
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
sharing ipd: Undecided