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    Summary
    EudraCT Number:2015-000849-23
    Sponsor's Protocol Code Number:HC-G-H-1403
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-04-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-000849-23
    A.3Full title of the trial
    A RANDOMIZED, CONTROLLED, DOUBLE-BLIND, MULTICENTER CLINICAL TRIAL ON HOME PARENTERAL NUTRITION USING AN OMEGA-3 FATTY ACID ENRICHED MCT/LCT LIPID EMULSION
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to investigate safety and efficacy of an Omega-3-fatty acid triglycerides (“fish-oil”) enriched lipid emulsion in comparison to a lipid emulsion not containing “fish-oil” in home parenteral nutrition in adults
    A.3.2Name or abbreviated title of the trial where available
    The HOME Study (HPN WITH OMEGA-3)
    A.4.1Sponsor's protocol code numberHC-G-H-1403
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorB. Braun Melsungen AG
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportB. Braun Melsungen AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAMS Advanced Medical Services GmbH
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressAm Exerzierplatz 2
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post code68167
    B.5.3.4CountryGermany
    B.5.4Telephone number+4962170095100
    B.5.5Fax number+4962170095140
    B.5.6E-mailoperations@ams-europe.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Lipidem, 200 mg/ml, emulsion for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Melsungen AG
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Emulsion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOmega-3-acid triglycerides
    D.3.9.3Other descriptive nameOMEGA-3-ACID TRIGLYCERIDES
    D.3.9.4EV Substance CodeSUB12189MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMEDIUM-CHAIN TRIGLYCERIDES BP
    D.3.9.3Other descriptive nameMEDIUM-CHAIN TRIGLYCERIDES BP
    D.3.9.4EV Substance CodeSUB179016
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSOYA-BEAN OIL REFINED
    D.3.9.3Other descriptive nameSOYA-BEAN OIL REFINED
    D.3.9.4EV Substance CodeSUB12326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Lipofundin MCT/LCT 20% (100 mg/ml + 100 mg/ml) emulsion for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderB. Braun Melsungen AG
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Emulsion for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMEDIUM-CHAIN TRIGLYCERIDES BP
    D.3.9.3Other descriptive nameMEDIUM-CHAIN TRIGLYCERIDES BP
    D.3.9.4EV Substance CodeSUB179016
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSOYA-BEAN OIL REFINED
    D.3.9.3Other descriptive nameSOYA-BEAN OIL REFINED
    D.3.9.4EV Substance CodeSUB12326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic intestinal failure
    E.1.1.1Medical condition in easily understood language
    Reduction of the gut function below the minimum absorption capability that is required to maintain health and/or growth
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10017947
    E.1.2Term Gastrointestinal disorders
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study 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.
    E.2.2Secondary objectives of the trial
    Secondary objective is the further evaluation of safety and efficacy of the lipid emulsion.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title: Modulation of hepatic steatosis by intravenous fish-oil enriched lipid emulsion in patients with intestinal failure associated liver disease

    Protocol V 1, dated 30.01.2017

    Related objectives:

    Main exploratory endpoint
    Quantification of hepatic fat content (HTCG,%) by proton magnetic resonance spectroscopy (1H-MRS) prior to (baseline) and at visit 2, after average 8 weeks of supplementation with fish oil enriched lipid emulsion (Lipoplus®) compared to patients who receive LCT/MCT lipid emulsion (Lipofundin MCT/LCT® 20%) as part of their parenteral nutrition.

    Additional exploratory endpoints with regards to liver steatosis
    -HTCG assessed by computer aided ultrasound (CAUS) compared to 1H-MRS at baseline and at visit 2
    -Liver fat unsaturation index (UI) at baseline and at visit 2

    Exploratory endpoints with regards to liver fibrosis
    -Evaluate liver stiffness using transient elastography (Fibroscan) at baseline and at visit 2
    -Evaluate enhanced liver fibrosis (ELF) score at baseline and at visit 2

    E.3Principal inclusion criteria
    1. Signed informed consent available
    2. Male or female patients ≥ 18 years of age
    3. Patients with chronic intestinal failure receiving HPN including lipids in whom
    the parenteral macronutrients have not been changed by more than 10% for
    at least 3 months
    4. Patients receiving ≥ 3.0 g lipids/kg body weight per week
    E.4Principal exclusion criteria
    1. Persistent high total bilirubin values in medical history of the last 6 months
    (> 40μmol/l)
    2. Patients in whom PN was interrupted for longer than 4 continuous weeks in
    the preceding 6 months
    3. Patients with history of cancer and anti-cancer treatment within the last
    2 years
    4. Hypersensitivity to egg, fish, peanut or soya-bean protein or to any of the active
    substances or excipients
    5. Patients treated in the past or currently with Teduglutide
    6. Contraindications to investigational products (if available from medical
    records) including:
    - Severe hyperlipidemia, including severe hypertriglyceridaemia (≥ 1000
    mg/dl or 11.4 mmol/l)
    - Severe coagulopathy
    - Intrahepatic cholestasis
    - Severe hepatic insufficiency
    - Severe renal insufficiency in absence of renal replacement therapy
    - Acute thromboembolic events
    - Fat embolism
    - Aggravating haemorrhagic diatheses
    - Metabolic acidosis
    7. General contraindications to parenteral nutrition (if available from medical
    records) including:
    - Unstable circulatory status with vital threat (states of collapse and shock)
    - Acute phase of cardiac infarction or stroke
    - Unstable metabolic conditions (e.g. decompensated diabetes mellitus,
    severe sepsis, coma of unknown origin)
    - Inadequate cellular oxygen supply
    - Disturbances of the electrolyte and fluid balance (e.g. hypokalaemia and
    hypotonic dehydration)
    - Acute pulmonary edema
    - Decompensated cardiac insufficiency
    8. Positive test for HIV, Hepatitis B or C (from medical history)
    9. Known or suspected drug or alcohol abuse
    10. Patients who are unwilling or mentally and/or physically unable to adhere to
    study procedures
    11. Participation in another interventional clinical trial in parallel or within three
    months prior to the start of this clinical trial
    12. Any medical condition that in the opinion of the investigator might put the
    subject at risk or interfere with patients participation
    For women with childbearing potential (i.e. females who are not chemically or
    surgically sterile or females who are not post-menopausal)
    13. Women of childbearing potential tested positive on standard pregnancy test
    (urine dipstick)
    14. Lactation
    15. Women of childbearing potential who do not agree to apply adequate
    contraception
    16. Persons of legal age who are the subject of a legal protection
    measure or who are unable to express their consent.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is the change of liver function
    parameters defined as the sum of the N(0,1)-transformed differences in
    bilirubin, Alanine transaminase (ALT) and Aspartate transaminase (AST)
    from baseline to visit 2.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint is visit 2 which is normally conducted after 8 weeks - allowed tolerance range from this is -3 days up to + 2 weeks.
    E.5.2Secondary end point(s)
    Secondary objective is the further evaluation of safety and efficacy and other parameters of the lipid emulsion.

    Safety
    * Hepatic function
    - Bilirubin
    - Alanine transaminase (ALT)
    - Aspartate transaminase (AST)
    - AST/ALT ratio*
    - Alkaline phosphatase (ALP)
    - Gamma-glutamyl transpeptidase (GGT)

    * Blood count and coagulation
    - White blood cells (WBCs)
    - Red blood cells (RBCs)
    - Hemoglobin (Hb)
    - Hematocrit (Hct)
    - Platelets
    - International normalized ratio (INR) (if not possible
    prothrombin time [PT = Quick-value] is accepted)
    - Activated partial thromboplastin time (aPTT)

    * Other biochemical parameters
    - Blood glucose
    - Electrolytes (Na, Cl, K, Ca, Mg, P)
    - Serum creatinin
    - Triglycerides
    - Cholesterol
    - High-density lipoprotein (HDL)
    - Low-density lipoprotein (LDL)
    - C-reactive protein (CRP)
    - α-Tocopherol/Vitamin E (facultative if routinely assessed)
    - Triene:tetraene ratio* obtained from fatty acid pattern in
    plasma

    *Adverse events (AEs)

    Efficacy
    - Fatty acid pattern in plasma and RBCs [% of FA] (only at baseline and at visit 2)
    - BMI [kg/m2]*

    Other variables
    * Demographic data
    - Age
    - Gender
    - Ethnic origin
    - Body height
    - Body weight

    * Anamnesis
    - Medical history relevant with regard to HPN
    - Pathological classification of IF
    - Underlying disease
    - Concomitant disease(s)
    - Ongoing medications
    - Lipid emulsion(s) during the last 6 months
    - Anamnestic peculiarities

    * Physical examination
    * Vital signs
    * Body weight change*
    * Quality of life (EQ-5DTM)
    * Concomitant medication
    * Energy requirements
    * PN regimen prescription
    * Treatment compliance*
    * Intake of oily fish meals
    * Study termination
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints are visit 1 which is normally conducted 4 weeks after start of IP infusion (allowed tolerance - 3 days up to + 2 weeks) and visit 2 which is normally conducted 4 weeks after visit 1 (allowed tolerance - 3 days up to + 2 weeks).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability.
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the final visit no IP must be administered. The treatment will continue according to the decision of the physician with a regularly used lipid emulsion.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-04-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-19
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