<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/NCT03282955</url>
  </required_header>
  <id_info>
    <org_study_id>HC-G-H-1403</org_study_id>
    <nct_id>NCT03282955</nct_id>
  </id_info>
  <brief_title>The HOME Study (HPN With OMEGA-3)</brief_title>
  <acronym>HOME</acronym>
  <official_title>A Randomized, Controlled, Double-blind, Multicenter Clinical Trial on Home Parenteral Nutrition Using an Omega-3 Fatty Acid Enriched MCT/LCT Lipid Emulsion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>B. Braun Melsungen AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>B. Braun Melsungen AG</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 trial is to investigate safety and tolerability of an Omega-3-FA-enriched&#xD;
      lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It&#xD;
      is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product)&#xD;
      in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with&#xD;
      regard to liver function.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 8, 2018</start_date>
  <completion_date type="Actual">July 19, 2022</completion_date>
  <primary_completion_date type="Actual">July 19, 2022</primary_completion_date>
  <phase>Phase 4</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of liver function parameters from baseline to visit 2</measure>
    <time_frame>8 weeks</time_frame>
    <description>Changes will be expressed as the sum of the N(0.1)-transformed differences of bilirubin, ALT and AST (visit 2 - baseline).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bilirubin</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alanine transaminase (ALT)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aspartate transaminase (AST)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AST/ALT ratio</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alkaline phosphatase (ALP)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gamma-glutamyl transpeptidase (GGT)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>White blood cells (WBCs)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Red blood cells (RBCs)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin (Hb)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Platelets</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International normalized ratio (INR) (if not possible prothrombin time [PT = Quick-value] is accepted)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activated partial thromboplastin time (aPTT)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematocrit (Hct)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sodium</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cloride</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Potassium</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Calcium</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Magnesium</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phosphate</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum creatinine</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglycerides</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High-density lipoprotein (HDL)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Low-density lipoprotein (LDL)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein (CRP)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>α-Tocopherol/Vitamin E (facultative if routinely assessed)</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatty acid pattern in plasma and RBCs</measure>
    <time_frame>8 weeks</time_frame>
    <description>Fatty acid pattern in plasma and RBCs, triene:tetraene ratio obtained from fatty acid pattern in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BMI</measure>
    <time_frame>8 weeks</time_frame>
    <description>Body mass index</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Patients Requiring Home Parenteral Nutrition</condition>
  <arm_group>
    <arm_group_label>Lipidem</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lipofundin MCT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>i.v. lipid emulsion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lipidem</intervention_name>
    <description>Lipoplus i.v. lipid emulsion for parenteral nutrition</description>
    <arm_group_label>Lipidem</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lipofundin MCT 20%</intervention_name>
    <description>Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition</description>
    <arm_group_label>Lipofundin MCT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  Signed informed consent available&#xD;
&#xD;
          -  Male or female patients ≥ 18 years of age&#xD;
&#xD;
          -  Patients with chronic intestinal failure receiving HPN including lipids in whom the&#xD;
             parenteral macronutrients have not been changed by more than 10% for at least 3 months&#xD;
&#xD;
          -  Patients receiving ≥ 3.0 g lipids/kg body weight per week&#xD;
&#xD;
        Exclusion:&#xD;
&#xD;
          -  Persistent high total bilirubin values in medical history of last 6 months (&gt;&#xD;
             40µmol/l)&#xD;
&#xD;
          -  Patients in whom PN was interrupted for longer than 4 continuous weeks in the&#xD;
             preceding 6 months&#xD;
&#xD;
          -  Patients with history of cancer and anti-cancer treatment within the last 2 years&#xD;
&#xD;
          -  Hypersensitivity to egg, fish, peanut or soya-bean protein or to any of the active&#xD;
             substances or excipients&#xD;
&#xD;
          -  Patients treated in the past or currently with Teduglutide&#xD;
&#xD;
          -  Contraindications to investigational products (if available from medical records)&#xD;
             including:&#xD;
&#xD;
               -  Severe hyperlipidemia, including severe hypertriglyceridaemia (≥1000 mg/dl or&#xD;
                  11.4 mmol/l)&#xD;
&#xD;
               -  Severe coagulopathy&#xD;
&#xD;
               -  Intrahepatic cholestasis&#xD;
&#xD;
               -  Severe hepatic insufficiency&#xD;
&#xD;
               -  Severe renal insufficiency in absence of renal replacement therapy&#xD;
&#xD;
               -  Acute thromboembolic events&#xD;
&#xD;
               -  Fat embolism&#xD;
&#xD;
               -  Aggravating haemorrhagic diatheses&#xD;
&#xD;
               -  Metabolic acidosis&#xD;
&#xD;
          -  General contraindications to parenteral nutrition (if available from medical records)&#xD;
             including:&#xD;
&#xD;
               -  Unstable circulatory status with vital threat (states of collapse and shock)&#xD;
&#xD;
               -  Acute phase of cardiac infarction or stroke&#xD;
&#xD;
               -  Unstable metabolic conditions (e.g. decompensated diabetes mellitus, severe&#xD;
                  sepsis, coma of unknown origin)&#xD;
&#xD;
               -  Inadequate cellular oxygen supply&#xD;
&#xD;
               -  Disturbances of the electrolyte and fluid balance (e.g. hypokalaemia and&#xD;
                  hypotonic dehydration)&#xD;
&#xD;
               -  Acute pulmonary edema&#xD;
&#xD;
               -  Decompensated cardiac insufficiency&#xD;
&#xD;
          -  Positive test for HIV, Hepatitis B or C (from medical history)&#xD;
&#xD;
          -  Known or suspected drug or alcohol abuse&#xD;
&#xD;
          -  Patients who are unwilling or mentally and/or physically unable to adhere to study&#xD;
             procedures&#xD;
&#xD;
          -  Participation in another interventional clinical trial in parallel or within three&#xD;
             months prior to the start of this clinical trial&#xD;
&#xD;
          -  Any medical condition that in the opinion of the investigator might put the subject at&#xD;
             risk or interfere with patients participation For women with childbearing potential&#xD;
             (i.e. females who are not chemically or surgically sterile or females who are not&#xD;
             post-menopausal)&#xD;
&#xD;
          -  Women of childbearing potential tested positive on standard pregnancy test (urine&#xD;
             dipstick)&#xD;
&#xD;
          -  Lactation&#xD;
&#xD;
          -  Women of childbearing potential who do not agree to apply adequate contraception&#xD;
&#xD;
          -  Persons of legal age who are the subject of a legal protection measure or who are&#xD;
             unable to express their consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hôpital Archet 2 - Unité de support nutritionnel</name>
      <address>
        <city>Nice</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospices Civiles de Lyon - Centre hospitalier Lyon Sud</name>
      <address>
        <city>Pierre-Bénite</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Medical and Surgical Science, University of Bologna, Center for Chronic Intestinal Failure, Department of Digestive System, St. Orsola-Malpighi Hospital</name>
      <address>
        <city>Bologna</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radboud university medical center</name>
      <address>
        <city>Nijmegen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanley Dudrick's Memorial Hospital</name>
      <address>
        <city>Skawina</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samodzielny Publiczny Szpital Kliniczny, im. prof. dr W. Orlowskiego, Centrum Medycznego Ksztalcenia Podyplomowego, Oddzial Kliniczny Zywienia i Chirurgii</name>
      <address>
        <city>Warszawa</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wojewódzkim Specjalistycznym Szpitalem im. M. Pirogowa w Łodzi , Oddział Chirurgii Ogólnej i Naczyniowej</name>
      <address>
        <city>Łódź</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS Foundation Trust</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College Hospital London</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Italy</country>
    <country>Netherlands</country>
    <country>Poland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 9, 2022</last_update_submitted>
  <last_update_submitted_qc>September 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03282955
org study id: HC-G-H-1403
nct id: NCT03282955
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the trial is to investigate safety and tolerability of an Omega-3-FA-enriched
      lipid emulsion in adult patients with chronic intestinal failure in need of long-term HPN. It
      is aimed to show non-inferiority of the lipid emulsion Lipidem (investigational test product)
      in comparison to the lipid emulsion Lipofundin MCT (investigational reference product) with
      regard to liver function.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change of liver function parameters from baseline to visit 2
time frame: 8 weeks
description: Changes will be expressed as the sum of the N(0.1)-transformed differences of bilirubin, ALT and AST (visit 2 - baseline).
measure: Bilirubin
time frame: 8 weeks
measure: Alanine transaminase (ALT)
time frame: 8 weeks
measure: Aspartate transaminase (AST)
time frame: 8 weeks
measure: AST/ALT ratio
time frame: 8 weeks
measure: Alkaline phosphatase (ALP)
time frame: 8 weeks
measure: Gamma-glutamyl transpeptidase (GGT)
time frame: 8 weeks
measure: White blood cells (WBCs)
time frame: 8 weeks
measure: Red blood cells (RBCs)
time frame: 8 weeks
measure: Hemoglobin (Hb)
time frame: 8 weeks
measure: Platelets
time frame: 8 weeks
measure: International normalized ratio (INR) (if not possible prothrombin time [PT = Quick-value] is accepted)
time frame: 8 weeks
measure: Activated partial thromboplastin time (aPTT)
time frame: 8 weeks
measure: Hematocrit (Hct)
time frame: 8 weeks
measure: Blood glucose
time frame: 8 weeks
measure: Sodium
time frame: 8 weeks
measure: Cloride
time frame: 8 weeks
measure: Potassium
time frame: 8 weeks
measure: Calcium
time frame: 8 weeks
measure: Magnesium
time frame: 8 weeks
measure: Phosphate
time frame: 8 weeks
measure: Serum creatinine
time frame: 8 weeks
measure: Triglycerides
time frame: 8 weeks
measure: Cholesterol
time frame: 8 weeks
measure: High-density lipoprotein (HDL)
time frame: 8 weeks
measure: Low-density lipoprotein (LDL)
time frame: 8 weeks
measure: C-reactive protein (CRP)
time frame: 8 weeks
measure: α-Tocopherol/Vitamin E (facultative if routinely assessed)
time frame: 8 weeks
measure: Fatty acid pattern in plasma and RBCs
time frame: 8 weeks
description: Fatty acid pattern in plasma and RBCs, triene:tetraene ratio obtained from fatty acid pattern in plasma
measure: Adverse events
time frame: 8 weeks
measure: BMI
time frame: 8 weeks
description: Body mass index
arm group label: Lipidem
arm group type: Experimental
description: i.v. lipid emulsion containing fractionated fish oil (n-3 fatty acid triglycerides)
arm group label: Lipofundin MCT
arm group type: Active Comparator
description: i.v. lipid emulsion
intervention type: Drug
intervention name: Lipidem
description: Lipoplus i.v. lipid emulsion for parenteral nutrition
arm group label: Lipidem
intervention type: Drug
intervention name: Lipofundin MCT 20%
description: Lipofundin MCT 20% i.v. lipid emulsion for parenteral nutrition
arm group label: Lipofundin MCT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Italy
country: Netherlands
country: Poland
country: United Kingdom
responsible party type: Sponsor