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    Summary
    EudraCT Number:2014-003680-38
    Sponsor's Protocol Code Number:HDVitC
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-03-04
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2014-003680-38
    A.3Full title of the trial
    Pharmacokinetics of two different high dose regimes of intravenous vitamin C in critically ill patients
    Farmacokinetiek van twee verschillende hoge doseerregimes van intraveneus vitamine C bij IC patiënten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the way the body absorbs, distributes and gets rid of two different high doses of vitamin C in patients in the intensive care unit
    Studie naar de manier waarop het lichaam twee verschillende hoge doseringen vitamine C opneemt, verdeelt en afvoert bij patiënten die op de intensive care liggen
    A.3.2Name or abbreviated title of the trial where available
    Pharmacokinetics of two different high dose regimes of intravenous vitamin C in critically ill patie
    Farmacokinetiek van twee verschillende hoge doseerregimes van intraveneus vitamine C bij IC patiënte
    A.4.1Sponsor's protocol code numberHDVitC
    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 SponsorVU university medical center
    B.1.3.4CountryNetherlands
    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 supportVU university medical center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU university medical center
    B.5.2Functional name of contact pointREVIVE
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31204443824
    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.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Critically ill patients with trauma or sepsis exhibit a high degree of vitamin C deficiency at ICU admission and vitamin C plasma concentrations decrease even more during the first three days of admission.
    IC patiënten met trauma of sepsis hebben een hoge mate van vitamine C deficiëntie bij opname en de vitamine C spiegels dalen nog verder gedurende de eerste drie dagen van opname.
    E.1.1.1Medical condition in easily understood language
    Critically ill patients with trauma or an infection in their bloodstream have low vitamine C levels. These vitamin C levels will become even lower during the first three days of admission.
    Intensive care (IC) patiënten met trauma of een infectie in hun bloed hebben een tekort aan vitamine C. Gedurende de eerste drie dagen van opname op de IC wordt deze vitamine C voorraad nog lager.
    E.1.1.2Therapeutic area Body processes [G] - Biological Phenomena [G16]
    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
    To determine the pharmacokinetics of two high dose regimens of intravenous vitamin C in critically ill patients, in particular the attained plasma concentration and the fraction retained in the body and excreted in urine.
    De farmacokinetiek bepalen van twee hoge doseerregimes van vitamine C bij IC patiënten, in het bijzonder de verkregen plasma concentraties en de opgenomen fractie vitamine C en uitgescheiden in urine.
    E.2.2Secondary objectives of the trial
    Not applicable
    Niet van toepassing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    >18 years
    Sepsis or SIRS (systemic inflammatory response syndrome), after major surgery or trauma
    Non-neurological sequential organ failure score >6
    Expected length of ICU stay > 96 hours
    Informed consent by patient or legal representative
    >18 jaar
    Sepsis of SIRS (systemic inflammatory response syndrome), na een grote operatie of trauma
    Niet neurologische sequential organ failure (SOFA) score >6
    Verwachte opnameduur op intensive care> 96 uren
    Informed consent door patiënt of wettelijke vertegenwoordiger
    E.4Principal exclusion criteria
    Admission after out of hospital cardiac arrest
    Prior use of supplemental vitamin C in the week before
    Major bleeding
    Pre-existent renal insufficiency defined as an eGFR of < 30 ml/min/1.73 m2 (stadium 4-5)
    Expected need for renal replacement therapy within 48 hours
    Known glucose 6-phosphate dehydrogenase deficiency
    History of urolithiasis or oxalate nephropathy
    Previous use of prolonged high dose vitamin C supplements
    Hemochromatosis
    Opname na reanimatie buiten het ziekenhuis
    Eerder gebruik van vitamine C als supplement in week voor opname
    Grote bloeding
    Bestaande nierinsufficiëntie gedefinieerd als een eGFR of < 30 ml/min/1.73 m2 (stadium 4-5)
    Verwachte behoefte aan niervervangende therapie binnen 48 uur
    Bekende glucose 6-phosphate dehydrogenase deficiëntie
    Urolithiasis of oxalaat nefropathie in de voorgeschiedenis
    Eerder gebruik van hoge doseringenvitamine C supplementen
    Hemochromatose
    E.5 End points
    E.5.1Primary end point(s)
    Plasma concentrations vitamin C
    Fraction of vitamin C excreted in urine in relation to the administered dose
    Clearance (Cl) (ml/min)
    Volume of distribution (Vd) (L)
    Elimination half life (t½) (hours)
    Plasma concentraties vitamine C
    Fractie vitamine C uitgescheiden in urine in relatie tot toegediende dosis
    Klaring (Cl) (ml/min)
    Verdelingsvolume (Vd) (L)
    Halfwaardetijd (t½) (uur)
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 days with blood samples at t<0, t=0, 1, 2, 4, 8, 12, 24, 36, 48, 72 and 96 hours
    5 dagen met bloedmonsters op t<0, t=0, 1, 2, 4, 8, 12, 24, 36, 48, 72 en 96 uur
    E.5.2Secondary end point(s)
    Reactive oxygen species (ROS) activity in blood (CellROX)
    Oxidative damage (F2 isoprostanes)
    Anion gap metabolic acidosis
    Reactive oxygen species (ROS) activiteit in bloed (CellROX)
    Oxidatieve schade (F2 isoprostanes)
    Anion gap metabole acidose
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 days with blood samples at t<0, t=1, 4, 8, 24, 48, 72 and 96
    5 dagen met bloedmonsters op t<0, t=1, 4, 8, 24, 48, 72 en 96
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    andere dosering vitamine C
    other dose of vitamin C
    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
    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 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Critically ill patients admitted to ICU
    IC patiënten
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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 Decision2015-06-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-02-25
    P. End of Trial
    P.End of Trial StatusOngoing
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