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    Summary
    EudraCT Number:2015-001614-94
    Sponsor's Protocol Code Number:15-PP-03
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-07-24
    Trial 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 ConcernedFrance - ANSM
    A.2EudraCT number2015-001614-94
    A.3Full title of the trial
    Hepatoprotective role of SMOFlipid® used in short-term parenteral nutrition in an Onco-Hematology Pediatric Population, pilot study
    Etude pilote du rôle hépatoprotecteur des SMOFlipid® en nutrition parentérale de courte durée chez des enfants suivis en Onco-Hématologie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hepatoprotective role of SMOFlipid® used in short-term parenteral nutrition in an Onco-Hematology Pediatric Population, pilot study
    Etude pilote du rôle hépatoprotecteur des SMOFlipid® en nutrition parentérale de courte durée chez des enfants suivis en Onco-Hématologie.
    A.3.2Name or abbreviated title of the trial where available
    SMOFPILOT
    A.4.1Sponsor's protocol code number15-PP-03
    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 SponsorCentre Hospitalier Universitaire de Nice
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCentre Hospitalier Universitaire de Nice
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier Universitaire de Nice
    B.5.2Functional name of contact pointLANDES
    B.5.3 Address:
    B.5.3.1Street Address4, avenue Reine Victoria
    B.5.3.2Town/ cityNice
    B.5.3.3Post code06000
    B.5.3.4CountryFrance
    B.5.4Telephone number+33492034126
    B.5.5Fax number+33492034075
    B.5.6E-maillandes.c@chu-nice.fr
    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 SMOFLIPID
    D.2.1.1.2Name of the Marketing Authorisation holderFRESENIUS KABI FRANCE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 IMPParenteral use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    D.3.11.13.1Other medicinal product typeacides gras essentiels et acides gras oméga 3
    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 MEDIALIPIDE
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRE B BRAUN MEDICAL
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 IMPParenteral use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 Yes
    D.3.11.13.1Other medicinal product typeacides gras essentiels
    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
    parenteral nutrition in an Onco-Hematology Pediatric Population
    E.1.1.1Medical condition in easily understood language
    parenteral nutrition in an Onco-Hematology Pediatric Population
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLT
    E.1.2Classification code 10065877
    E.1.2Term Dietary and nutritional therapies
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    to evaluate the impact of the use of SMOFlipid® in parenteral nutrition on early occurrence of cholestasis compared with Médialipides in a short-term use of parenteral nutrition in an Onco-Hematology pediatric population.
    Evaluer l’impact sur l’apparition précoce d’une cholestase d’une NP à base de SMOFlipid® versus Médialipides® dans la NP à court terme chez le patient d’Onco-hématologie pédiatrique.
    E.2.2Secondary objectives of the trial
    To assess the impact on hepatic function laboratory tests, tolerance to lipids, number of infectious episodes, and the impact on inflammatory proteins
    évaluer l’impact sur le bilan hépatique, la tolérance lipidique, le nombre d’épisodes infectieux, l’impact sur les protéines de l’inflammation.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    0-18 years
    Solid Tumors, hematological malignancies
    Requiring parenteral nutrition during at least 5 days
    With a central catheter
    With a normal hepatic function test
    Enfant de 0 à 18 ans
    Enfant raité pour une hémopathie ou une tumeur solide
    Nécessitant une NP d’au moins 5 jours
    Porteur d’un cathéter central (KTc)
    Avec un bilan hépatique normal
    E.4Principal exclusion criteria
    Liver function tests disrupted
    Patient with an infectious syndrome at the time of inclusion
    Patient with a tumor or liver metastases
    Patient with against-indication to the use of lipid emulsions
    Bilan hépatique perturbé
    Patient présentant un syndrome infectieux au moment de l’inclusion
    Patient présentant une tumeur ou des métastases hépatiques
    Patient présentant une contre-indication à l’utilisation des émulsions lipidiques
    E.5 End points
    E.5.1Primary end point(s)
    dosage of γGT in UI/l
    Dosage des γGT, potentiel marqueur précoce de cholestase, en UI/l
    E.5.1.1Timepoint(s) of evaluation of this end point
    D0, D5, D7
    J0, J5, J+7
    E.5.2Secondary end point(s)
    asat, alat, PAL, LDH, total bilirubin
    CRP, IL-6
    Triglycerids
    Digestive tolerance (vomiting)
    Infectious episodes (numbers, duration)
    Nutritionnal status (Albumin, weight, BMI)
    Tolérance hépatique évaluée par le dosage des marqueurs hépatiques Transaminases ASAT ALAT; PAL ; LDH ; Bilirubinémie totale.
    Impact nutritionnel évalué par l’Albuminémie, le dosage de la Pré Albumine et Gain pondéral estimé par le poids et l’IMC, une seule balance par chambre et non interchangeable
    Tolérance lipidique évaluée par le dosage des triglycérides : à jeun, 1 heure après la fin de la NP.
    Effet immunomodulateur évalué sur le dosage de la CRP
    Tolérance clinique : vomissement
    Risque infectieux : nombre et durée d’épisodes fébriles
    E.5.2.1Timepoint(s) of evaluation of this end point
    D0, D5, D7
    J0, J5, J+7
    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 No
    E.6.4Safety No
    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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 30
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 2
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 4
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 12
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 12
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under age incapable of giving consent personally
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    None
    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 Decision2015-06-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-10-18
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