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    Summary
    EudraCT Number:2017-003406-40
    Sponsor's Protocol Code Number:RK2017
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-08-17
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2017-003406-40
    A.3Full title of the trial
    Repetitive blood donations and endurance sport performance: does iron supplementation limit the negative effects on hematological parameters?
    Dons de sang répétés et performance en endurance: est-ce qu’une supplémentation en fer peut limiter les effets négatifs sur les paramètres hématologiques?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Repetitive blood donations and endurance sport performance: does iron supplementation limit the negative effects on hematological parameters?
    Dons de sang répétés et performance en endurance: est-ce qu’une supplémentation en fer peut limiter les effets négatifs sur les paramètres hématologiques?
    A.4.1Sponsor's protocol code numberRK2017
    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 SponsorUniversité catholique de Louvain
    B.1.3.4CountryBelgium
    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 supportRode Kruis Vlanderen
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversité catholique de Louvain
    B.5.2Functional name of contact pointLouise Deldicque
    B.5.3 Address:
    B.5.3.1Street AddressPlace Pierre de Coubertin n°1
    B.5.3.2Town/ cityLouvain-La-Neuve
    B.5.3.3Post code1348
    B.5.3.4CountryBelgium
    B.5.4Telephone number003210474443
    B.5.6E-maillouise.deldicque@uclouvain.be
    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 Losferron
    D.2.1.1.2Name of the Marketing Authorisation holderS.A. GRÜNENTHAL N.V.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Effervescent tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFERROUS GLUCONATE
    D.3.9.1CAS number 299-29-6
    D.3.9.3Other descriptive nameFERROUS GLUCONATE
    D.3.9.4EV Substance CodeSUB13867MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number695
    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 No
    D.IMP: 2
    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 Losferron
    D.2.1.1.2Name of the Marketing Authorisation holderS.A. GRÜNENTHAL N.V.
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 Effervescent tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFERROUS GLUCONATE
    D.3.9.1CAS number 299-29-6
    D.3.9.3Other descriptive nameFERROUS GLUCONATE
    D.3.9.4EV Substance CodeSUB13867MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number173.75
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    healthy subjects moderately active undergoing repeated blood donations
    Sujets sains, modérément actifs, subissant des dons de sang de manière répétée
    E.1.1.1Medical condition in easily understood language
    healthy subjects moderately active undergoing repeated blood donations
    Sujets sains, modérément actifs, subissant des dons de sang de manière répétée
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    We propose to measure the impact of 3 blood donations, interspersed by 3 months, on blood parameters and on performance during a maximal incremental test and to see whether iron supplementation can limit or even reverse the negative effects of donations on blood parameters reflecting iron status.
    L'objectif de cette étude est d'évaluer l'impact de 3 dons de sang, à intervalle de 3 mois, sur les paramètres sanguins et la performance sportif durant un test d'effort maximal et d'étudier si la supplémentation en fer peut limiter les effets négatifs de la donation sur les paramètres sanguins reflétant le statut en fer.
    E.2.2Secondary objectives of the trial
    not applicable
    pas applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age between 18-50 years
    - BMI between 20-28 kg/m2
    - hours sport per week between 1-6
    - good health
    - age entre 18-50 ans
    - IMC entre 20-28 kg/m2
    - 1-6h de sport par semaine
    - bonne santé
    E.4Principal exclusion criteria
    - hematochromatose (coefficient of transferrin saturation >45% and ferritin >300μg/l)
    - iron deficiency (ferritin <12μg/l)
    - iron supplementation
    - nutritional supplements intake (such as vitamins or minerals)
    - hématochromatose (coefficient de saturation de la transferrine >45% et ferritine >300μg/l)
    - déficience en fer (ferritine <12μg/l)
    - supplémentation en fer
    - consommation de compléments alimentaires (vitamines, mineraux,...)
    E.5 End points
    E.5.1Primary end point(s)
    VO2 max
    VO2 max
    E.5.1.1Timepoint(s) of evaluation of this end point
    one week before blood donation and 2 days after, 1 week after, 2 weeks after and 4 weeks after blood donation. This timepoints will be used at each blood donnation (3 in total), with a interval of three months
    une semaine avant le don de sang et 2 jours après, 1 semaine après, 2 semaines après et 4 semaines après le don de sang. Ce schéma sera répété à chaque don de sang (3 au total), avec un intervalle de 3 mois.
    E.5.2Secondary end point(s)
    - haematological parameters: hematocrit, hemoglobin, red blood cells, iron, transferrin, ferritin, erythropoietin, soluble transferrin receptor and hepcidin.
    - hemoglobin mass
    - sport performance during an exercise test: lactate, heart rate
    - paramètres hématologiques: hématocrite, hémoglobine, globules rouges, fer, transferrine, ferritine, érythropoïétine, récepteur soluble de la transferrine et l'hepcidine.
    - la masse de l’hémoglobine
    - performance sportive durant un test d'effort: lactate, rythme cardiaque
    E.5.2.1Timepoint(s) of evaluation of this end point
    one week before blood donation and 2 days after, 1 week after, 2 weeks after and 4 weeks after blood donation. This timepoints will be used at each blood donnation (3 in total), with a interval of three months
    une semaine avant le don de sang et 2 jours après, 1 semaine après, 2 semaines après et 4 semaines après le don de sang. Ce schéma sera répété à chaque don de sang (3 au total), avec un intervalle de 3 mois.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    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 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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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
    the end of the trial is the last visit of the subject, when iron supplement or placebo is finished
    la fin de l'étude est lors de la dernière visite du dernier sujet, quand la supplémentation en fer ou en placebo est terminée
    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 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: 44
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state44
    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
    Rien
    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 Decision2017-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-30
    P. End of Trial
    P.End of Trial StatusCompleted
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