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    Summary
    EudraCT Number:2019-000730-19
    Sponsor's Protocol Code Number:DC2019ROCKIES1
    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:2020-03-05
    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 number2019-000730-19
    A.3Full title of the trial
    A phase 4, monocenter, prospective, randomized, placebo-controlled, double-blind, cross-over mechanistic intervention trial to assess effect of 4-week Ertugliflozin (SGLT-2 inhibitor) therapy on renal (cortical and medullary) oxygenation as determined by BOLD-MRI (R2*) and renal (cortical and medullary) oxygen consumption as determined by positron emission tomography (PET) using ¹¹C-acetate in patients with type 2 diabetes mellitus and healthy controls.
    Een fase 4, monocenter, prospectief, gerandomiseerd, placebo-gecontroleerd, dubbelblind, cross-over, mechanistisch interventie onderzoek naar de effecten van 4 weken Ertugliflozine (SGLT-2 remmer) behandeling op renale (corticale en medullaire) oxygenatie als beoordeeld op BOLD-MRI (R2*) en renaal (corticaal en medullair) zuurstof verbruik als beoordeeld op PET-CT in patienten met type 2 diabetes mellitus ten opzichte van gezonde controles.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of SGLT-2 inhibitors (antihyperglycemic agent) on renal tissue oxygen saturation and oxygen and oxygen consumption in patients with type 2 diabetes mellitus.
    Het efffect van SGLT2-remmers (bloedsuiker verlagend medicament) op het zuurstof niveau en zuurstof verbruik van de nier in patienten met diabetes mellitus type 2.
    A.3.2Name or abbreviated title of the trial where available
    Renal Oxygenation, Consumption and hemodynamic Kinetics in DIabetes 2: Ertugliflozin Study (ROCKIES)
    Renale zuurstOf Consumptie en hemodynamieK in dIabetes: een Ertugliflozine Studie (ROCKIES)
    A.4.1Sponsor's protocol code numberDC2019ROCKIES1
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1231-6807
    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 SponsorAmsterdam Univeristy Medical Center - Vu Univeristy 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 support Merck sharp & dohme (MSD)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam Univeristy Medical Center - Vu Univeristy Medical Center
    B.5.2Functional name of contact pointDaniel van Raalte
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31(0)204440534
    B.5.6E-maild.vanraalte@vumc.nl
    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 Steglatro (ertugliflozin)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Film-coated 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 INNERTUGLIFLOZIN
    D.3.9.1CAS number 1210344-57-2
    D.3.9.4EV Substance CodeSUB182716
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 placeboFilm-coated tablet
    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
    Type 2 Diabetes Mellitus
    Type 2 Diabetes Mellitus
    E.1.1.1Medical condition in easily understood language
    Diabetes
    Diabetes
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    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 investigate the effect of 4-week treatment with SGLT-2 inhibitor ertugliflozin 15mg QD on renal (separated as cortical and medullar) oxygenation meausured by BOLD-MRI (R2*).
    Onderzoek naar het effect van 4-weken behandeling met SGLT-2 remmer Ertugliflozine 15mg 1dd1 op renale (corticale en medullaire) oxygenatie gemeten met BOLD-MRI (R2*).
    E.2.2Secondary objectives of the trial
    • Renal oxygen consumption as determined by positron emission tomography -scan using ¹¹C-acetate (compartement
    model parameter k2)
    • Renal hemodynamics (GFR/ ERPF)
    • Filtration Fraction
    • Estimated glomerular pressure, resistance of the afferent and efferent arteriole (by using the Gomez formulae and the iohexol- and PAH-derived renal physiology parameters).
    • Renal efficiency measured as amount of sodium reabsorption relative to oxygen consumption
    • Renal cortical blood flow
    • Renal arterial blood flow measured by ASL and DCE-MRI
    • 24-hour sodium and glucose excretion after 2 days (acute response) and 4 weeks (chronic response)
    • Renal tubular function
    • Renal damage markers
    • Inflammatory profile
    • Changes in plasma energy substrates
    • Changes in erythropoietin levels
    • Insulin sensitivity and beta-cell function during an oral glucose tolerance test
    • Peripheral insulin extraction and total arterial insulin extraction
    • Energy expenditure
    • Renale zuurstof consumptie gemeten door positron emissie tomografie (PET)/CT scan met gebruik van ¹¹C-acetate (compartement
    model parameter k2).
    • Renale hemodynamiek (GFR/ ERPF)
    • Filtratie Fractie
    • Geschatte glomerulaire druk, en weerstand van de afferente- en efferente arteriool (met gebruik van de Gomez formulae)
    • Renale efficientie gemeten als hoeveelheid natriumreabsorptie ten opzichte van zuurstofconsumptie
    • Renaal corticale doorbloeding
    • Renale arteriele doorbloeding gemeten door ASL en DCE-MRI
    • 24-uurs zout en glucose excretie na 2 dagen (acute respons) en 4 weken (chronische respons)
    • Renale tubulaire functie
    • Renale schademarkers
    • Inflammatoir profiel
    • Verandering in erythropoietine (EPO) niveau
    • Veranderingen in plasma energie substraten
    • Insuline sensitiviteit en Beta-cel functie gedurende een orale glucose tolerantie test (OGTT)
    • Perifere insuline extractie en totale arteriele insuline extractie
    • Energie verbruik
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Group 1: patients with diabetes
     Provision of signed and dated, written informed consent prior to any study specific procedures.
     Caucasian*; female or male aged ≥18 years and <80 years. Females must be post-menopausal (defined as FSH>31U/L).
     Type 2 diabetes mellitus since at least 3 years with HbA1c ≥ 6.5% (≥57mmol/mol) and <10% (<94mmol/mol)
     An appropriate stable dose of metformin and/or sulfonylurea as glucose-lowering therapy for the last 12 weeks
     Maximum tolerated antihypertensive dose of an ARB for at least 6 weeks prior to randomization.
     eGFR 60-90 ml/min/1.73m²
     BMI ≥25 kg/m²
    * In order to increase homogeneity

    Group 2: age-mathed and eGFR-matched non-diabetic controls
     Provision of signed and dated, written informed consent prior to any study specific procedures.
     Caucasian*; female or male aged ≥18 years and <80 years. Females must be post-menopausal (defined as FSH>31U/L).
     Normal glucose tolerance at screening as confirmed by OGTT
     Maximum tolerated antihypertensive dose of an ARB for at least 6 weeks prior to randomization.
     eGFR 60-90 ml/min/1.73m²
     BMI ≥25 kg/m²
    * In order to increase homogeneity
    Groep 1: patienten met diabetes
     Getekend en gedateerd toestemmingsformulier voorafgaand aan studie specifieke procedures.
     Kaukasisch*; vrouw of man in de leeftijd van ≥18 jaar en <80 jaar. Vrouwen moeten post-menopauzaal zijn (gedefinieerd als een FSH >31U/L).
     Type 2 diabetes mellitus sinds ten minste 3 jaar met HbA1c ≥ 6.5% (≥57mmol/mol) en <10% (<94mmol/mol)
     Een gepaste stabiele dosis van metformine en/of een sulfonylureum derivaat als glucose-verlagende therapie voor de laatste 12 weken
     Maximum getolereerde antihypertensieve dosis van een ARB voor ten minste 6 weken voorafgaand aan de randomizatie
     eGFR 60-90 ml/min/1.73m²
     BMI ≥25 kg/m²
    * Ter bevordering van homogeniteit

    Groep 2: op leeftijd- en eGFR gematchte non-diabetische controle participanten
     Getekend en gedateerd toestemmingsformulier voorafgaand aan studie specifieke procedures.
     Kaukasisch*; vrouw of man in de leeftijd van ≥18 jaar en <80 jaar. Vrouwen moeten post-menopauzaal zijn (gedefinieerd als een FSH >31U/L).
     Ongestoorde glucose tolerantie ten tijde van de screening zoals bevestigd door een OGTT
     Maximum getolereerde antihypertensieve dosis van een ARB voor ten minste 6 weken voorafgaand aan de randomizatie
     eGFR 60-90 ml/min/1.73m²
     BMI ≥25 kg/m²
    * Ter bevordering van homogeniteit
    E.4Principal exclusion criteria
    Group 1: Type 2 diabetes patients
     Involvement in the planning and/or conduction of another study
     Previous participation in another clinical study with an investigational product during the last 3 months
     Diagnosis of type 1 diabetes mellitus
     CKD defined as eGFR<60 ml/min/1.73m² or macro-albuminuria (defined as UACR>30 mg/mol)
     Cardiovascular disease event in the last 6 months prior to enrollment as assessed by the investigator: myocardial infarction, cardiac surgery or revascularization (CABG/PTCA), unstable angina, heart failure, transient ischemic attack (TIA) or significant cerebrovascular disease, unstable or previously undiagnosed arrhythmia.
     Current/chronic use of the following medication: thiazolidinediones, GLP-1 receptor agonists, DPP-4 inhibitors, SGLT-2 inhibitors, oral glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), immune suppressants, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs), diuretics, and monoamine oxidase inhibitors.
     Pre-menopausal women
     Current urinary tract infection or active nephritis
     History of ketoacidosis
     History of allergy/hypersensitivity to any of the test agents.
     Contra-indication for MRI
     Any other condition that prevents participation as judged by investigator.

    Group 2: Age-matched and eGFR matched non-diabetic controls
     Involvement in the planning and/or conduction of another study
     Previous participation in another clinical study with an investigational product during the last 3 months
     CKD defined as eGFR<60 ml/min/1.73m² or macro-albuminuria (defined as UACR>30 mg/mmol)
     Cardiovascular disease event in the last 6 months prior to enrollment as assessed by the investigator: myocardial infarction, cardiac surgery or revascularization (CABG/PTCA), unstable angina, heart failure, transient ischemic attack (TIA) or significant cerebrovascular disease, unstable or previously undiagnosed arrhythmia.
     Current/chronic use of the following medication: oral glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), immune suppressants, chemotherapeutics, antipsychotics, tricyclic antidepressants (TCAs), diuretics, and monoamine oxidase inhibitors.
     Pre-menopausal women
     Current urinary tract infection or active nephritis
     History of ketoacidosis
     History of allergy/hypersensitivity to any of the test agents.
     Contra-indication for MRI
     Any other condition that prevents participation as judged by investigator.
    Groep 1: Patienten met type 2 diabetes
     Betrokkenheid bij de planning en /of uitvoering van een andere studie
     Eerdere participatie in een andere klinische studie met een onderzoeksproduct investigational product in de laatste 3 maanden
     Diagnose van type 1 diabetes mellitus
     CKD gedefinieerd als eGFR<60 ml/min/1.73m² of macro-albuminurie (gedefinieerd als UACR>30 mg/mmol)
     Een cardiovasculair ziekte incident in de laatste 6 maanden voorafgaand aan deelname zoals beoordeeld door de onderzoeker: hartinfarct, cardiale chirurgie of revascularisatie (CABG/PTCA), onstabiele angina, hartfalen, transient ischemic attack (TIA) of andere significante cerebrovasculair ziekte, onstabiele of eerder ongediagnosticeerde aritmie.
     Huidig/chronisch gebruik van de volgende medicatie: thiazolidinediones, GLP-1 receptor agonisten, DPP-4 remmers, SGLT-2 remmers, orale glucocorticoiden, non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppressiva, chemotherapeutice, antipsychotica, tricyclic antidepressiva (TCAs), diuretica, en monoamine oxidase remmers.
     Pre-menopauzale vrouwen
     Huidige urineweginfectie of actieve nefritis
     Geschiedenis van ketoacidosis
     Geschiedenis van allergie/hypersensitiviteit voor een van de test agents
     Contraindicatie voor de MRI
     Elke andere conditie die studiedeelname verhinderd zoals beoordeeld door de onderzoeker.

    Groep 2: gezonde controles die gematcht zijn op leeftijd en nierfunctie
     Betrokkenheid bij de planning en /of uitvoering van een andere studie
     Eerdere participatie in een andere klinische studie met een onderzoeksproduct investigational product in de laatste 3 maanden
     CKD gedefinieerd als eGFR<60 ml/min/1.73m² of albuminurie (gedefinieerd als UACR> 30mg/mmol)
     Een cardiovasculair ziekte incident in de laatste 6 maanden voorafgaand aan deelname zoals beoordeeld door de onderzoeker: hartinfarct, cardiale chirurgie of revascularisatie (CABG/PTCA), onstabiele angina, hartfalen, transient ischemic attack (TIA) of andere significante cerebrovasculair ziekte, onstabiele of eerder ongediagnosticeerde aritmie.
     Huidig/chronisch gebruik van de volgende medicatie: orale glucocorticoiden, non-steroidal anti-inflammatory drugs (NSAIDs), immunosuppressiva, chemotherapeutice, antipsychotica, tricyclic antidepressiva (TCAs), diuretica, en monoamine oxidase remmers.
     Pre-menopauzale vrouwen
     Huidige urineweginfectie of actieve nefritis
     Geschiedenis van ketoacidosis
     Geschiedenis van allergie/hypersensitiviteit voor een van de test agents
     Contraindicatie voor de MRI
     Elke andere conditie die studiedeelname verhinderd zoals beoordeeld door de onderzoeker.
    E.5 End points
    E.5.1Primary end point(s)
    To investigate the effect of 4-week treatment with SGLT-2 inhibitor ertugliflozin 15mg QD on renal (separated as cortical and medullar) oxygenation meausured by BOLD-MRI (R2*).
    Onderzoek naar het effect van 4-weken behandeling met SGLT-2 remmer Ertugliflozine 15mg 1dd1 op renale (verdeeld in corticale en medullaire) oxygenatie gemeten met BOLD-MRI (R2*).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be assessed after 4 weeks of treatment.
    Het primaire eindpunt zal na 4 weken van behandeling worden onderzocht.
    E.5.2Secondary end point(s)
    • Renal oxygen consumption as determined by positron emission tomography (PET)-CT scan using ¹¹C-acetate (compartement model parameter k2).
    • Renal hemodynamic (GFR/ERPF); measured by the gold standard iohexol and PAH-clearance method
    • Filtration fraction (FF)
    • Estimated glomerular pressure (PGLO), resistance of the afferent (RA) and efferent (RE) arteriole (by using the Gomez formulae and the iohexol- and PAH-derived renal physiology parameters).
    • Renal efficiency measured as sodium reabsorption (TNa) divided by oxygen consumption
    • Cortical blood flow measured by contrast-enhanced ultrasound (CEUS)
    • Renal arterial blood flow measured by arterial spin labelling (ASL) and Dynamic contrast enhanced MRI (DCE-MRI)
    • 24-hour sodium and glucose excretion after 2 days (acute response) and 4 weeks (chronic response)
    • Renal tubular function, measures as:
    o Iohexol-corrected fractional sodium excretion
    o Urine osmolality
    o Urinary pH
    • Renal damage markers, measured as:
    o Urinary albumin excretion in 24-hour urine samples
    • Changes in inflammatory profile
    • Changes in erythropoietin (EPO) levels
    • Changes in plasma substrates including glucose, free fatty acids, ketone bodies, and triglycerides
    • Insulin sensitivity (OGIS, Matsuda Index) and beta-cell function (as derived from HOMA-B) during an oral glucose tolerance test (OGTT).
    • Peripheral insulin extraction and total arterial insulin extraction (extraction x arterial flow)
    • Energy expenditure by resting energy expenditure (REE)
    • Renale zuurstof consumptie gemeten door positron emissie tomografie (PET)/CT-scan met gebruik van ¹¹C-acetate (compartement
    model parameter k2).
    • Renale hemodynamiek (GFR) gemeten met de gouden standaard van de Iohexol en PAH- klaringstehcniek.
    • Filtration Fractie (FF)
    • Geschatte glomerulaire druk (PGLO), weerstand van de afferente (RA) en efferente (RE) arteriool (met gebruik van de Gomez formulae en de iohexol- and PAH-afgeleide parameters).
    • Renale efficientie gemeten als natrium reabsorptie (TNa) gedeeld door zuurstof consumptie
    • Corticale doorbloeding gemeten met contrast-enhanced ultrasound (CEUS)
    • Renale arteriele doorbloeding gemeten met arterial spin labelling (ASL) en dynamic enhanced contrast MRI (DCE-MRI)
    • 24-uurs zout en glucose excretie na 2 dagen (acute respons) en 4 weken (chronische respons)
    • Renale tubulaire functie gemeten als:
    o Iohexol-gecorigeerde fractionele natrium excretie
    o Urine osmolaliteit
    o Urine pH
    • Renale schademarkers
    o Urine albumine excretion in 24-uurs urine samples
    • Verandering in inflammatoir profiel
    • Verandering in erythropoietine (EPO) niveau
    • Veranderingen in plasma substraten inclusief glucose, vrije vetzuren, keton lichamen, en triglyceriden
    • Insuline sensitiviteit (OGIS, Matsuda Index) en Beta-cel functie (HOMA-B) gedurende een orale glucose tolerantie test (OGTT)
    • Perifere insuline extractie en totale arteriele insuline extractie (extractie x arteriale bloedstroom)
    • Energie verbruik gemeten door een resting energy expenditure (REE)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints will all be assessed after 4 weeks of treatment, with exclusion of acute natriuretic respons which is assessed after 2 days of treatment.
    De secondaire eindpunten zullen worden onderzocht na 4 weken van behandeling,met exclusie van acute natriuretische respons hetgeen onderzocht zal worden na 2 dagen van behandeling.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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
    Mechanistic- The aim of the trial is to assess the effect of 4 week treatment with SGLT-2 inhibitor Ertugliflozin on renal oxygenation, renal oxygen use, and renal hemodynamics.
    Mechanistisch - Het doel van deze studie is om het effect van 4 weken gebruik van SGLT-2 remmer Ertugliflozine op renale oxygenatie, zuurstof consumptie, en renale hemodynamiek te onderzoeken.
    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 No
    E.8.1.6Cross over Yes
    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 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 years2
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients Yes
    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 state40
    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)
    No different treatment is expected after completion of the study. Patients are able to stay under the care of AUMC- location VUmc hospital or can go back in to the care of their own physician.
    Naar verwachting zal de behandeling van de participanten niet veranderen. De participanten kunnen na afloop van de studie onder de zorg blijven van het AUMC- locatie VUmc of zullen terug gaan in de zorg van hun eigen behandelend arts.
    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 Decision2020-03-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-01
    P. End of Trial
    P.End of Trial StatusCompleted
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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