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    Summary
    EudraCT Number:2014-001666-10
    Sponsor's Protocol Code Number:20140415
    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:2014-06-23
    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 number2014-001666-10
    A.3Full title of the trial
    Local delivery of CER-001 in advanced plaques
    Proof-of-concept for apoA-1 as initiator of reverse cholesterol transport (LOCATION)
    Lokale afgifte van CER-001 in gevorderde plaques
    Conceptueel bewijs voor apoA-1 als initiator van omgekeerd cholesteroltransport
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Proving that an HDL mimetic (CER-001) arrives at and removes cholesterol in atherosclerotic plaques in patients after infusion therapy
    Bewijzen dat een synthetisch HDL analoog (CER-001) aankomt en cholesterol verwijderd in atherosclerotische plaques in patienten na intraveneuze toediening
    A.3.2Name or abbreviated title of the trial where available
    LOCATION
    LOCATION
    A.4.1Sponsor's protocol code number20140415
    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 SponsorAcademic Medical Center Amsterdam
    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 supportAcademic Medical Center Amsterdam
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointResearcher vascular medicine
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number310205662377
    B.5.5Fax number310205669343
    B.5.6E-mailk.h.zheng@amc.uva.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 nameZirconium-89 labeled recombinant human apolipoprotein A-1/phospholipids complex
    D.3.2Product code 89Zr-CER-001
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRecombinant human apolipoprotein A-1
    D.3.9.2Current sponsor codeCER-001
    D.3.9.3Other descriptive nameAPOLIPOPROTEIN A-I, HUMAN
    D.3.9.4EV Substance CodeSUB88507
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNZirconium-89
    D.3.9.2Current sponsor code89Zr
    D.3.9.3Other descriptive nameZIRCONIUM-89
    D.3.9.4EV Substance CodeSUB130861
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNp-isothiocyanatobenzyl desferrioxamine
    D.3.9.1CAS number 70-51-9
    D.3.9.3Other descriptive nameDESFERRIOXAMINE
    D.3.9.4EV Substance CodeSUB33303
    D.3.10 Strength
    D.3.10.1Concentration unit mol/g mole(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number752.9
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSphingomyelin
    D.3.9.3Other descriptive nameSPHINGOMYELIN
    D.3.9.4EV Substance CodeSUB31959
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20.95
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN1,2-dihexadecanoyl-sn-glycero-3-phospho-(1'-rac-glycerol)
    D.3.9.1CAS number 200880-41-7
    D.3.9.2Current sponsor codeDPPG
    D.3.9.3Other descriptive name1,2-DIHEXADECANOYL-SN-GLYCERO-3-PHOSPHO-(1’-RAC-GLYCEROL)
    D.3.9.4EV Substance CodeSUB77417
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.65
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    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
    Atherosclerosis
    Atherosclerose
    E.1.1.1Medical condition in easily understood language
    Atherosclerosis, vascular disease
    Aderverkalking, hart- en vaatziekten
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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 demonstrate that 89Zr-CER-001 penetrates into atherosclerotic plaques in patients by means of PET imaging.
    Aantonen dat 89Zr-CER-001 aankomt in atherosclerotische plaques van patiënten met PET-imaging
    E.2.2Secondary objectives of the trial
    To evaluate whether the amount of 89Zr-CER-001 penetrating the plaque corresponds to athero-lesion severity.
    To evaluate whether the amount of 89Zr-CER-001 penetrating the plaque corresponds to plaque permeability.
    To evaluate whether the amount of 89Zr-CER-001 penetrating the plaque corresponds to the cholesterol efflux capacity
    Onderzoeken of de hoeveelheid 89Zr-CER-001 die aankomt in de plaque correspondeert met de ernst van de atherosclerotische laesie
    Onderzoeken of de hoeveelheid 89Zr-CER-001 die aankomt in de plaque correspondeert met de permeabiliteit van de plaque
    Onderzoeken of de hoeveelheid 89Zr-CER-001 die aankomt in de plaque correspondeert met de cholesterol efflux capaciteit
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet the following criteria for study entry:
    - Adult patients (either gender) ≥ 50 years
    - Documented atherosclerotic vascular disease; defined as either peripheral arterial disease or documented aortic or carotid atherosclerosis on clinical vascular MRI or ultrasound
    - Clinically stable for at least 3 months prior to inclusion
    - Very high CV-risk (based on Framingham risk engine)
    - Volwassen patiënten (zowel mannen als vrouwen) ≥ 50 jaar
    - Gedocumenteerd vaatlijden: gedefineerd als perifeer vaatlijden of gedocmenteerde atherosclerose van de aorta of carotiden met MRI of echo
    - Ten minste 3 maanden klinisch stabiel voor de inclusie
    - Ernstig verhoogd risico op hart- en vaatziekten
    E.4Principal exclusion criteria
    Patients are not eligible if they meet one of the criteria listed below:
    - Creatinine clearance < 50 ml/min (MDRD) 6 months prior to inclusion
    - Auto-immune disease/vasculitis, other active inflammatory diseases, proven or suspected bacterial infections. Recent (<1 month prior to inclusion) or ongoing serious infection requiring IV antibiotic therapy that could interfere with the conduct of the study in the opinion of the investigator
    - Known systemic disorders such as hepatic, renal, hematologic, and malignant diseases or any clinically significant medical condition that could interfere with the conduct of the study in the opinion of the investigator
    - Standard contra-indications to MRI, PET, and CT
    - Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study
    Patiënten komen niet in aanmerking als zij voldoen aan een van de volgende criteria:
    - Creatinineklaring < 50 ml/min (MDRD) 6 maanden voorafgaand aan de inclusie
    - Auto-immuunziekten/vasculitis, andere actieve inflammatoire ziekten, bewezen of verdenking op bacteriële infectie. Recente (< 1 maand voor inclusie) of actieve ernstige infectie, waarvoor IV behandeling met antibiotica nodig is, die invloed zou kunnen uitoefenen op het beloop van het onderzoek naar het oordeel van de onderzoeker
    - Bekende systemische aandoeningen zoals lever-, nier-, hematologische en maligne aandoeningen of een klinisch significante medische aandoening die invloed zouden kunnen uitoefenen op het beloop van het onderzoek naar de mening van de onderzoeker
    - Standaard contra-indicaties voor MRI, PET en CT
    - Niet het vermogen of de wil om te voldoe
    E.5 End points
    E.5.1Primary end point(s)
    The CER-001 uptake in the plaque over time by means of PET imaging of the aorta and carotid arteries, reported as Standardized Uptake Value (SUV) of the plaque.
    De primaire uitkomstmaat is de 89Zr-CER-001 opname in de plaque gedurende een tijdsperiode, uitgedrukt als de Standardized Uptake Value (SUV), met behulp van PET-imaging.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PET-imaging will be performed after infusion of 89Zr-CER-001, at timepoints of 10 minutes after infusion, after 24 hours and after 72 hours.
    PET-scans zullen worden vervaardigd na infusie van 89Zr-CER-001 na 10 minuten, na 24 uur en na 72 uur.
    E.5.2Secondary end point(s)
    Further quantification of CER-001 uptake at the plaque
    - 89Zr-CER-001 uptake in the plaque over time assessed as the Target to Background Ratio (TBR), via PET imaging
    - Difference between SUV and TBR at the level of the plaque and SUV and TBR of non-diseased arterial wall on PET

    Relation between CER-001 uptake and plaque characteristics
    - Relation between SUV and TBR of the plaque on PET and structural plaque dimensions on MRI i.e. normalized wall index, vessel wall area. - Relation between SUV and TBR of the plaque and plaque permeability on DCE-MRI, i.e. Ktrans

    Relationship between the CER-001 uptake in the plaque by means of PET imaging reported as SUV of the plaque and the cholesterol efflux capacity.
    Verdere kwantificatie van CER-001 opname in de plaque:
    - 89Zr-CER-001 opname in de plaque gedurende een tijdperiode, uitgedrukt als de Target to Background Ratio (TBR), met behulp van PET-imaging
    - Het verschil tussen SUV en TBR op plaque-niveau en het verschil van SUV en TBR op gezonde vaatwand, met behulp van PET-imaging

    De relatie tussen CER-001 opname en plaque karakteristieken
    - De relatie tussen SUV en TBR van de plaque op de PET en structurele plaque afmetingen op MRI (bijv. normalized wall index, vessell wall area)
    - De relatie tussen SUV en TBR van de plaque en plaque permabiliteit op DCE-MRI (bijv. Ktrans)

    De relatie tussen CER-001 opname in de plaque met behulp van PET-imaging en de cholesterol efflux capaciteit
    E.5.2.1Timepoint(s) of evaluation of this end point
    In addition to the PET-scans performed, an MRI will be performed after patients have been screened.
    Naast de PET-scans zal er tevens een MRI worden vervaardigd nadat patiënten zijn gescreend.
    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 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) 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 No
    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
    The end of the study will have been reached after visit 4, in which the third/last PET-CT scan will be performed, 72 hours after the infusion of Zr89-CER-001.
    Het einde van het onderzoek wordt bereikt na visite 4, nadat de derde/laatste PET-CT scan is gemaakt, 72 uur nadat Zr89-CER-001 is toegediend.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 16
    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 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 state16
    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)
    Patients will return to their expected normal care from the outpatient clinic of Vascular Medicine. There are no special plans for treatment or care for subjects.
    Patiënten zullen de normale zorg ontvangen. Er zijn geen speciale vervolgplannen wat betreft de zorg.
    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 Decision2014-06-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-24
    P. End of Trial
    P.End of Trial StatusOngoing
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