Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2019-004282-41
    Sponsor's Protocol Code Number:CEL-02
    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:2019-12-09
    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 number2019-004282-41
    A.3Full title of the trial
    A Phase-2 open label study to assess the pharmacodynamic and pharmacokinetic properties of a single subcutaneous injection of RUC-4 in patients with ST-elevation myocardial infarction presenting to cardiac catheterization lab with planned primary coronary angioplasty
    Een fase-2 open-label studie om de farmacodynamische en farmacokinetische eigenschappen van een éénmalige subcutane injectie met RUC-4 te beoordelen, bij patiënten met een ST-elevatie myocardinfarct, die zich presenteren op het hartkatheterisatie laboratorium met als doel een primaire coronaire angioplastiek uit te voeren.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the effects of a platelet inhibitor (RUC-4). This platelet inhibitor is given by a single subcutaneous injection.
    Targeted patients are patients with an acute myocardial infarction. The medication will be given on the cardiac catheterization lab. Subsequently a coronary angiography will be perormed and if needed the patient will be treated with primary coronary angioplasty
    Een onderzoek om de effecten van een bloedplaatjesremmer (RUC-4) te beoordelen. Deze bloedplaatjesremmer wordt toegediend via een éénmalige onderhuidse injectie. De doelgroep is patiënten met een acuut myocardinfarct. Het medicament wordt geïnjecteerd bij presentatie op het hartkatheterisatie laboratorium. Vervolgens zal een coronaire angiografie worden uitgevoerd en zo nodig zal de patiënt aansluitend worden behandeld met een Dotter-behandeling.
    A.3.2Name or abbreviated title of the trial where available
    CEL-02 trial
    CEL-02 studie
    A.4.1Sponsor's protocol code numberCEL-02
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04284995
    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 SponsorCeleCor Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportCeleCor Therapeutics, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDiagram BV
    B.5.2Functional name of contact pointS. Postma
    B.5.3 Address:
    B.5.3.1Street AddressDokter Stolteweg 96
    B.5.3.2Town/ cityZwolle
    B.5.3.3Post code8025 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number003138426 2999
    B.5.6E-mails.postma@diagram-zwolle.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 No
    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.3.1Product nameRUC-4
    D.3.2Product code 140962
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRUC-4
    D.3.9.2Current sponsor codeRUC-4
    D.3.9.3Other descriptive nameGLYCOPROTEIN IIB/IIIA
    D.3.9.4EV Substance CodeSUB194833
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.075
    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
    Patients with STEMI, presenting with persistent chest pain (>30 min) and ≥ 1 mm ST-segment elevation in two adjacent electrocardiograph leads, with > 6 mm cumulative ST-segment deviation, in whom the total duration of symptom to first intracoronary device deployment (excluding a wire) is anticipated to be within 6 hours. Patients are adult males and females 18 years of age or older.
    Patiënten met STEMI, die zich presenteren met aanhoudende klachten van pijn op de borst (> 30 min) en ST-segment elevatie van ≥ 1 mm in twee aangrenzende ECG-afleidingen, waarbij de cumulatieve ST-segmentafwijking > 6 mm is, bij wie naar verwachting de totale duur van de klachten tot het eerste intracoronaire device gebruik (exclusief een draad) minder dan 6 uur zal zijn. Patiënten zijn volwassen: mannen en vrouwen van 18 jaar of ouder.
    E.1.1.1Medical condition in easily understood language
    Patients with an Acute Myocardial Infarction presenting with specific abnormalities on their electrocardiogram. These patients are scheduled to undergo PCI (dotter treatment).
    Patiënten met een acuut myocardinfarct met specifieke afwijkingen op hun elektrocardiogram. Waarvan verwacht wordt dat zij met spoed een PCI (dotterbehandeling) zullen ondergaan.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLGT
    E.1.2Classification code 10028593
    E.1.2Term Myocardial disorders
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10000891
    E.1.2Term Acute myocardial infarction
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10028600
    E.1.2Term Myocardial ischaemia
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10081099
    E.1.2Term Acute cardiac event
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10062084
    E.1.2Term Platelet aggregation
    E.1.2System Organ Class 10022891 - Investigations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10050661
    E.1.2Term Platelet aggregation inhibition
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To assess the PD properties of a single subcutaneous injection of RUC-4 in STEMI patients presenting to the CCL with the aim to perform primary coronary angioplasty.
    - To assess the PK properties of a single subcutaneous injection of RUC-4 in STEMI patients presenting to the CCL with the aim to perform primary coronary angioplasty.
    - To assess safety and tolerability of RUC-4
    - Het beoordelen van de PD-eigenschappen van een éénmalige subcutane injectie met RUC-4 bij STEMI-patiënten die zich presenteren op de HCK met de intentie een primaire coronaire angioplastiek uit te voeren.
    - Het beoordelen van de PK-eigenschappen van een éénmalige subcutane injectie van RUC-4 bij STEMI-patiënten die zich presenteren op de HCK met de intentie een primaire coronaire angioplastiek uit te voeren.
    - het beoordelen van de veiligheid en tolerantie van RUC-4
    E.2.2Secondary objectives of the trial
    - To assess platelet count at select time points before and after RUC-4 administration
    - To assess bleeding events* of a single SC injection of RUC-4 at select timepoints after RUC-4 administration, at discharge and at 15-day and at 30-day follow-up
    - To assess intraprocedural thrombosis
    - To assess the injection site reactions of a single subcutaneous injection of RUC-4 at select timepoints after RUC-4 administration and at 15-day and at 30-day follow-up
    - To evaluate any differences in PD or PK within each treatment group (gender, weight, BMI, age)

    * According to the BARC (II, III and V), ISTH Major and TIMI Major
    criteria
    - het beoordelen van het aantal bloedplaatjes op specifieke tijdstippen voor en na toediening van RUC-4
    - het beoordelen van bloedingscomplicaties*, na een éénmalige SC injectie van RUC-4, op specifieke tijdstippen, op moment van ontslag en na 15 en 30 dagen follow-up
    - het beoordelen van intraprocedurele trombose
    - het beoordelen van (huid)reacties op op de injectieplaats, na een éénmalige subcutane injectie van RUC-4, op specifieke tijdstippen en na 15 en 30 dagen follow-up
    - evalueren van verschillen in PD of PK binnen enige behandelingsgroep (geslacht, gewicht, BMI, leeftijd)

    * volgens de BARC (II, III en V), ISTH Major en TIMI Major criteria
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with STEMI, presenting with persistent chest pain (>30 min) and ≥ 1 mm ST-segment elevation in two adjacent ECG-leads, with > 6 mm cumulative ST-segment deviation, in whom the total duration of symptom to first intracoronary device deployment (excluding a wire) is anticipated to be within 6 hours
    - Adult males and females 18 years of age or older
    - Females must be non-pregnant, non-lactating, and of non-childbearing potential (postmenopausal or surgically sterilized)
    - Weight (by history) of between 52 and 120 kg
    - Written informed consent (following short-form of the informed consent form at CCL)
    - Patiënten met STEMI, die zich presenteren met aanhoudende klachten van pijn op de borst (> 30 min) en ST-segment elevatie van ≥ 1 mm in twee aangrenzende ECG-afleidingen, waarbij de cumulatieve ST-segmentafwijking > 6 mm is, bij wie naar verwachting de totale duur van de klachten tot het eerste intracoronaire device gebruik (exclusief een draad) minder dan 6 uur zal zijn
    - Volwassen mannen en vrouwen van 18 jaar of ouder
    - Vrouwen mogen niet zwanger zijn, geen borstvoeding geven en niet vruchtbaar zijn (postmenopauzaal of chirurgisch gesteriliseerd)
    - Gewicht (volgens de anamnese) tussen 52 en 120 kg
    - Schriftelijke en ondertekende toestemming (na korte (mondelinge) vorm van de toestemmingsprocedure op de HCK)
    E.4Principal exclusion criteria
    - High probability in the opinion of the cardiologist that current STEMI is caused by stent thrombosis and the previous PCI related to this stent thrombosis is < 1 month
    - Current active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines).
    - High suspicion of type II MI
    - Out of hospital cardiac arrest (OHCA)
    - Therapy resistant cardiogenic shock (systolic blood pressure ≤ 80 mm Hg for > 30 minutes)
    - Persistent severe hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg)
    - Known severe liver disease
    - Known history of severe renal dysfunction (glomerular filtration rate < 30 mL/min or serum creatinine > 200 mmol/L [> 2.5 mg/dL])
    - Known left bundle branch block
    - Requirement of oral anticoagulation (Vitamin K antagonists {VKA} or direct oral antagonists {DOACs})
    - Chronic use of P2Y12 antagonists
    - Current treatment with αIIbβ3 receptor antagonist (other than RUC-4)
    - Coagulation abnormality, known bleeding disorder, or history of documented prior hemorrhagic or thrombotic stroke < 6 months
    - History of upper or lower GI bleeding within the past 6 months
    - Known clinically important anemia
    - Known clinically important thrombocytopenia (platelet count of less than 150,000/μL)
    - Known history of allergy to any of the ingredients in the RUC-4 formulation (i.e., acetate buffer, sucrose)
    - Major surgery within the past 6 months
    - Life expectancy of less than 6 months
    - Any clinically significant abnormality identified prior to enrollment that in the judgment of the Investigator would preclude safe completion of the study
    - Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the patient’s ability to comply with the study protocol.
    - Hoge waarschijnlijkheid dat het huidige STEMI wordt veroorzaakt door stenttrombose, waarbij de vorige PCI, met betrekking tot deze stenttrombose, < 1 maand geleden is
    - Huidige COVID-19 besmetting (criteria volgens lokale richtlijnen).
    - Hoog vermoeden van type II MI
    - Out of Hospital Cardiac arrest (OHCA)
    - Therapieresistente cardiogene shock (systolische bloeddruk ≤ 80 mm Hg > 30 minuten)
    - Aanhoudende ernstige hypertensie (systolische bloeddruk > 180 mm Hg of diastolische bloeddruk > 110 mm Hg)
    - Bekende een ernstige leveraandoening
    - Bekende ernstige nierfunctiestoornis (glomerulaire filtratiesnelheid < 30 ml / min of serumcreatinine > 200 mmol / L [> 2,5 mg / dL])
    - Bekend met een linker bundeltakblok
    - Noodzaak voor behandeling met orale antistolling (vitamine K-antagonisten {VKA} of directe orale antagonisten {DOACs})
    - Chronisch gebruik van P2Y12-antagonisten
    - Huidige bestaande behandeling met αIIbβ3-receptorantagonist (anders dan RUC-4)
    - Stollingsafwijking, bekende bloedingsstoornis of voorgeschiedenis van gedocumenteerde eerdere hemorragische of trombotische beroerte < 6 maanden
    - Geschiedenis van bovenste of onderste GI-bloeding in het afgelopen jaar
    - Bekende klinisch belangrijke bloedarmoede
    - Bekende klinisch belangrijke trombocytopenie (aantal bloedplaatjes minder dan 150.000 / µL)
    - Voorgeschiedenis met allergie voor een van de bestanddelen van de RUC-4-medicatie (bijvoorbeeld: acetaatbuffer, sucrose)
    - Grote chirurgische ingreep in de laatste 6 maanden
    - Levensverwachting van minder dan 6 maanden
    - Elke klinisch significante afwijking die vóór de inschrijving is vastgesteld en die naar het oordeel van de onderzoeker veilige voltooiing van de studie uitsluit
    - Onwil of onvermogen om te voldoen aan de vereisten van dit protocol, inclusief de aanwezigheid van een aandoening (fysiek, mentaal of sociaal) die waarschijnlijk van invloed is op het vermogen van de patiënt om aan het studieprotocol te voldoen
    E.5 End points
    E.5.1Primary end point(s)
    - Inhibition of thrombin receptor activating peptide (TRAP)-induced platelet aggregation (%) assessed by VerifyNow at baseline, and at 15, 45, 60, 90, 120, 180 and 240 minutes after administration of RUC-4 (the 240 minute time point is only applicable if the RUC-4 dose is increased in cohort 2 and/or 3)
    - RUC-4 concentration (ng/mL) versus time profiles (at baseline and at 15, 45, 90, 120 and 180 minutes after administration of RUC 4) and associated PK parameters
    - Safety and tolerability parameters at baseline and at hospital discharge
    - Remming van TRAP-geïnduceerde bloedplaatjesaggregatie (%) beoordeeld door VerifyNow op baseline en 15, 45, 60, 90, 120, 180 en 240 minuten na toediening van RUC-4 (240 minuten is alleen van toepassing als de RUC-4 dosis in cohort 2 en/of 3 wordt verhoogd)
    - RUC-4 concentratie (ng/ml) en PK parameters op baseline en 15, 45, 90, 120 en 180 minuten na toediening van RUC 4
    - Veiligheids- en tolerantieparameters op baseline en op moment van ontslag
    E.5.1.1Timepoint(s) of evaluation of this end point
    see primary end points (E.5.1)
    zie primaire eindpunten (E.5.1)
    E.5.2Secondary end point(s)
    - Platelet count (μL) at baseline, and at 15, 45, 90, 120 and 180 minutes after administration of RUC-4 and at hospital discharge
    - Bleeding events (according to BARC II, III and V criteria for safety assessment and according to ISTH Major and TIMI Major for information only) at baseline, discharge and at 15-day and 30-day follow-up
    - Intraprocedural thrombosis (assessed by PI)
    - Injection site reactions at baseline, 1-hour post-PCI, hospital discharge, and at 15-day and 30-day follow-up
    - Inhibition of ADP-induced platelet aggregation (%) assessed by VerifyNow at baseline, and at 15, 45, 60, 90, 120, 180 and 240 minutes after administration of RUC-4 (the 240 minute time point is only applicable if the RUC-4 dose is increased in cohort 2 and/or 3)
    - Differences in PD or PK among the patients (gender, weight, BMI, age)
    - Aantal bloedplaatjes (μL) op baseline en op 15, 45, 90, 120 en 180 minuten na toediening van RUC-4
    - Bloedingen (volgens de BARC-criteria (II, III en V)) op baseline, op moment van ontslag en na 15 en 30 dagen follow-up
    - Intraprocedurele trombose
    - Reacties op de injectieplaats op baseline, 1 uur na PCI, op moment van ontslag en na 15 en 30 dagen follow-up
    - Remming van ADP-geïnduceerde bloedplaatjesaggregatie (%) beoordeeld door VerifyNow op baseline en 15, 45, 60, 90, 120, 180 en 240 minuten na toediening van RUC-4 (240 minuten is alleen van toepassing als de RUC-4 dosis in cohort 2 en/of 3 wordt verhoogd)
    - Verschillen in PD of PK tussen de patiënten (geslacht, gewicht, BMI, leeftijd)
    E.5.2.1Timepoint(s) of evaluation of this end point
    see secondary end points (E.5.2)
    zie secundaire eindpunten (E.5.2)
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    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 Yes
    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
    Standard care will be performed from time of consent through last study visit. The end of study for a given subject is reached when the 30 day assessment has been completed. The end of the whole study is met when all patients have completed all assessments, all data have been cleaned and study site has been closed.
    Premature termination of the study: a possible reason for early study termination includes that the SRC makes a decision for the early termination of the study per recommendation.
    Standaardzorg wordt verleend gedurende de studie tot het laatste studiebezoek. Het einde van de studie voor de patiënt wordt bereikt als de beoordeling na 30 dagen is voltooid. Het einde van de volledige studie is bereikt als alle patiënten alle beoordelingen hebben voltooid, alle gegevens zijn opgeschoond en de onderzoekslocatie is gesloten. Een reden voor vroegtijdige beëindiging van het onderzoek is: dat op voorspraak van de SRC een besluit genomen wordt om de studie voortijdig te beëindigen.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days6
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 No
    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
    Geen
    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 Decision2019-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-04
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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.

    European Medicines Agency © 1995-Sun May 05 12:45:36 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA