<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/NCT03801577</url>
  </required_header>
  <id_info>
    <org_study_id>CTN01019401</org_study_id>
    <nct_id>NCT03801577</nct_id>
  </id_info>
  <brief_title>Hepaxa Management of Non-alcoholic Fatty Liver Disease</brief_title>
  <official_title>Hepaxa Management of Non-Alcoholic Fatty Liver Disease (NAFLD): A Real-world Pilot Study Observing Effects of Nutritional Management With Hepaxa in Subjects With Liver Steatosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BASF AS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BASF AS</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>
      This study measures the steatosis in patients With fatty livers as determined by CAP score&#xD;
      from a fibroscan assessment. The study attempts to determine the effect of using the Medical&#xD;
      Food Hepaxa in a Clinical setting Close to real-world use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects With fatty liver are given Hepaxa for 6 months. Fibroscan CAP measurements are taken&#xD;
      at 3 monthly intervals. Subjects consent to Collection of data from approximately 6 months&#xD;
      prior to use of Hepaxa. Patients unresponsive to life style recommendations given as standard&#xD;
      practice will be enrolled.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">October 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Subjects are screened for eligibility and on consent, historical data from liver fat measurements With CAP scores, will be collected from the previous 6 months. Only subjects With no, or poor response to lifestyle recommendations will be enrolled.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change in liver fat content (hepatic steatosis) from baseline to end of study</measure>
    <time_frame>6 months</time_frame>
    <description>Liver fat will be measured using the &quot;Controlled Attenuation Parameter&quot; from the ultrasound based Fibroscan machine</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in liver function test: aspartate aminotransferase (AST) from baseline (IU/L) to end of study</measure>
    <time_frame>6 months</time_frame>
    <description>Blood test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the liver function test: alanine aminotransferase (ALT) from baseline (IU/L) to end of study</measure>
    <time_frame>6 months</time_frame>
    <description>Blood test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the liver function test: gamma glutamyltransferase (GGT) from baseline (IU/L) to end of study</measure>
    <time_frame>6 months</time_frame>
    <description>Blood test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Level of plasma triglycerides from baseline to end of study</measure>
    <time_frame>6 months</time_frame>
    <description>Blood test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight from baseline to end of study</measure>
    <time_frame>6 months</time_frame>
    <description>Blood test</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Exploratory outcome. Stratification of effect Hepaxa using FLI score</measure>
    <time_frame>6 months</time_frame>
    <description>The fatty liver index score will be used to stratify patients for analysis of effect of Hepaxa</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Non-Alcoholic Fatty Liver Disease</condition>
  <condition>Non Alcoholic Fatty Liver</condition>
  <condition>NASH - Nonalcoholic Steatohepatitis</condition>
  <arm_group>
    <arm_group_label>Hepaxa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will receive Hepaxa according to standard use (4 capsules daily over a 6 month period)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Hepaxa</intervention_name>
    <description>High concentrate EPA and DHA</description>
    <arm_group_label>Hepaxa</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men or women, ≥18 years of age.&#xD;
&#xD;
          2. Suspicion of NAFLD&#xD;
&#xD;
          3. Able to understand and cooperate with study procedures, and have signed a written&#xD;
             informed consent prior to any study procedures.&#xD;
&#xD;
          4. CAP score at -6 months and at inclusion of &gt;268&#xD;
&#xD;
          5. A fibroscan elastography score &lt;9 Kpa (Advanced Fibrosis)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Other causes of liver inflammation including Hepatitis A, B or C, HIV, confirmed or&#xD;
             suspected cirrhosis, Wilson's disease, autoimmune hepatitis, hemochromatosis,&#xD;
             alcoholic steatohepatitis, pancreatitis, or prescription medications known to cause&#xD;
             liver damage, or known to be hepatotoxic.&#xD;
&#xD;
          2. Significant weight loss (&gt; 5% body weight) or rapid weight loss (&gt;1.6 kg/week), within&#xD;
             six months of screening.&#xD;
&#xD;
          3. Individuals taking prescription or supplemental omega-3 fatty acids.&#xD;
&#xD;
          4. Has a condition the Investigator believes would interfere with the evaluation of the&#xD;
             subject, or may put the subject at undue risk during the course of the study,&#xD;
             including potentially abnormal lab results, due to a traumatic event.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reed Hogan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GI Associates and Endoscopy Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GI Associates and Endoscopy Center</name>
      <address>
        <city>Flowood</city>
        <state>Mississippi</state>
        <zip>39232</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Nick Childers</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>January 10, 2019</last_update_submitted>
  <last_update_submitted_qc>January 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>omega-3</keyword>
  <keyword>nafld</keyword>
  <keyword>nafl</keyword>
  <keyword>nash</keyword>
  <keyword>medical food</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Only anonymized data will be shared With the Sponsor. The study protocol and report may be shared, and presented as Scientific posters and peer-reviewed articles.</ipd_description>
  </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/NCT03801577
org study id: CTN01019401
nct id: NCT03801577
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study measures the steatosis in patients With fatty livers as determined by CAP score
      from a fibroscan assessment. The study attempts to determine the effect of using the Medical
      Food Hepaxa in a Clinical setting Close to real-world use.
Subjects With fatty liver are given Hepaxa for 6 months. Fibroscan CAP measurements are taken
      at 3 monthly intervals. Subjects consent to Collection of data from approximately 6 months
      prior to use of Hepaxa. Patients unresponsive to life style recommendations given as standard
      practice will be enrolled.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Subjects are screened for eligibility and on consent, historical data from liver fat measurements With CAP scores, will be collected from the previous 6 months. Only subjects With no, or poor response to lifestyle recommendations will be enrolled.
primary purpose: Treatment
masking: None (Open Label)
measure: The change in liver fat content (hepatic steatosis) from baseline to end of study
time frame: 6 months
description: Liver fat will be measured using the "Controlled Attenuation Parameter" from the ultrasound based Fibroscan machine
measure: Change in liver function test: aspartate aminotransferase (AST) from baseline (IU/L) to end of study
time frame: 6 months
description: Blood test
measure: Change in the liver function test: alanine aminotransferase (ALT) from baseline (IU/L) to end of study
time frame: 6 months
description: Blood test
measure: Change in the liver function test: gamma glutamyltransferase (GGT) from baseline (IU/L) to end of study
time frame: 6 months
description: Blood test
measure: Change in Level of plasma triglycerides from baseline to end of study
time frame: 6 months
description: Blood test
measure: Change in weight from baseline to end of study
time frame: 6 months
description: Blood test
measure: Exploratory outcome. Stratification of effect Hepaxa using FLI score
time frame: 6 months
description: The fatty liver index score will be used to stratify patients for analysis of effect of Hepaxa
arm group label: Hepaxa
arm group type: Experimental
description: Subjects will receive Hepaxa according to standard use (4 capsules daily over a 6 month period)
intervention type: Dietary Supplement
intervention name: Hepaxa
description: High concentrate EPA and DHA
arm group label: Hepaxa
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Reed Hogan, MD
role: Principal Investigator
affiliation: GI Associates and Endoscopy Center
facility: 
contact: 
country: United States
responsible party type: Sponsor
mesh term: Liver Diseases
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: No
ipd description: Only anonymized data will be shared With the Sponsor. The study protocol and report may be shared, and presented as Scientific posters and peer-reviewed articles.