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    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).

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    Summary
    EudraCT Number:2014-005462-30
    Sponsor's Protocol Code Number:MDCO-APO-14-01
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2016-09-12
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2014-005462-30
    A.3Full title of the trial
    A multiple dose, dose-finding, placebo controlled, double blind, randomized trial to compare the effect of treatment on plaque burden as determined by intravascular ultrasound and evaluate the efficacy, safety, and tolerability of MDCO-216 given as multiple weekly infusions in subjects with a recent acute coronary syndrome event
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to look at the changes in the fatty deposits in the walls of the blood vessels of the heart and blood levels of the "good" cholesterol and safety when MDCO-216 is taken at different doses in patients with a recent heart problem caused by a decreased blood flow to the heart.
    A.3.2Name or abbreviated title of the trial where available
    MILANO DRIVE
    A.4.1Sponsor's protocol code numberMDCO-APO-14-01
    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 SponsorThe Medicines Company
    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 supportThe Medicines Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Medicines Company
    B.5.2Functional name of contact pointGlobal Health Science Center
    B.5.3 Address:
    B.5.3.1Street Address8 Sylvan Way
    B.5.3.2Town/ cityParsippany
    B.5.3.3Post codeNJ 07054
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018889776326
    B.5.5Fax number0019736561929
    B.5.6E-mailmedical.information@themedco.com
    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 nameMDCO-216
    D.3.4Pharmaceutical form Concentrate for 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 INNrApoA-IM Protein (dimer)
    D.3.9.1CAS number 1508281-61-5
    D.3.9.2Current sponsor codeMDCO-216
    D.3.9.3Other descriptive namePROTEIN INTERMEDIATE r-Apo-AI Milano
    D.3.9.4EV Substance CodeSUB89722
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number12 to 18
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (critical raw material)
    D.3.9.1CAS number 26853-31-6
    D.3.9.3Other descriptive name1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE (POPC)
    D.3.9.4EV Substance CodeSUB30396
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number11 to 17
    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 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    acute coronary syndrome
    E.1.1.1Medical condition in easily understood language
    arteries clogged up by fatty substances known as plaques
    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 evaluate the effect of MDCO-216 treatment on the change in PAV of a target coronary artery, as measured by IVUS imaging, following MDCO-216 compared with placebo in subjects with CAD and a recent ACS event in order to establish safety and the dose and regimen for Phase III clinical trials.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of MDCO-216 on the following additional atheroma parameters measured by IVUS:
    - Change in TAV from baseline to Day 36 post randomization
    - Change in TAV in the 10 mm subsegment with the greatest disease burden at baseline
    - Proportion of subjects who demonstrate regression of coronary atherosclerosis, defined as reduction in PAV from baseline to Day 36 of more than 2 standard deviations (SD) of the test/re-test variability.
    - Proportion of subjects who demonstrate regression of coronary atherosclerosis, defined as a change in PAV from baseline to Day 36 of less than zero (ie, any reduction in PAV from baseline)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male or female subjects greater than or equal to 18 years of age
    2.Have experienced a recent ACS event within 14 days of randomization that requires a clinically indicated coronary angiogram
    3.A qualifying ACS event is defined as a spontaneous MI:
    A diagnosis of a qualifying MI event will be defined by abnormal levels of cardiac biomarkers (troponin I or T or creatinine kinase-myocardial isoenzyme band [CK-MB] mass) with at least one determination greater than the 99th percentile or upper limits of normal for the laboratory and at least one of the following:
    •Chest discomfort or symptoms of myocardial ischemia (greater than or equal to 10 minutes) at rest within 24 hours prior to hospitalization for MI
    •New electrocardiogram (ECG) findings (or presumed new if no prior ECG available) indicative of acute myocardial ischemia in absence of left ventricular hypertrophy and left bundle branch block (LBBB) as listed:
    -New or presumed new ST depression greater than 0.5 millimeters (mm) in two contiguous leads or T-wave inversion greater than 1 mm in leads with predominant R wave or R/S greater than 1mm in two contiguous leads
    -New or presumed new ST elevation at the J point in ≥2 contiguous leads with the cut-off points: ≥0.2 mV in men or ≥0.15mV in women in leads V2-V3 and/or ≥0.1 mV in other leads or new or presumed new LBBB
    -New tall R wave >40 ms in V1, V2 and R/S ≥1 in V1 with concordant positive T-wave in the absence of a conduction defect
    -New Q waves ≥30 ms wide and >1mm deep in any 2 leads of a contiguous lead grouping or Q wave >20 ms or QS complex in leads V2 and V3 (These criteria also apply to silent MI detected during a routine follow-up visit)
    •Loss of viable myocardium based on imaging evidence of new or presumed new wall motion or perfusion deficit (eg, echocardiography, left ventriculography during cardiac catheterization radionuclide angiography, single-photon emission tomography, magnetic resonance imaging)
    4.Baseline coronary angiogram must meet all of the following criteria for IVUS interrogation of Target Artery:
    TARGET ARTERY:
    •Must be accessible to the IVUS catheter
    •Must have a stenotic area of ≥20% and <50% in lumen diameter by angiographic visual estimation within the length of the native coronary artery (“target segment”) for imaging by IVUS
    •The target artery has not undergone prior percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG)
    •The target artery is not currently a candidate for intervention or a likely candidate for intervention over the treatment phase of the study and until the second IVUS interrogation at Day 36
    •The target artery may not be a bypass graft
    •The target artery may not be the culprit vessel for a previous MI TARGET ARTERY MAY HAVE:
    •A lesion of up to 60% stenosis, distal to the target segment, provided that this area is not a target for PCI or CABG
    •A single branch of the “target vessel” may have a narrowing less than or equal to 70% by visual estimation, provided that the branch in question is not a target for PCI or CABG
    5.Willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures
    E.4Principal exclusion criteria
    1.Baseline IVUS not completed due to non-qualifying coronary angiogram as demonstrated by:
    •Greater than 50% reduction in lumen of the left main coronary artery by visual estimation
    •Extensive CAD with no target vessel for IVUS interrogation
    2.Baseline IVUS interrogation determined to be unacceptable by the Atherosclerosis Imaging Core Laboratory
    3.Clinically significant heart disease which, in the opinion of the investigator, is likely to require CABG, PCI, cardiac transplantation, and surgical or percutaneous valve repair and/or replacement following index IVUS imaging (does not apply to PCI that occurs as a result of initial screening angiogram and completed prior to index IVUS imaging)
    4.New York Heart Association class III or IV heart failure or last known left ventricular ejection fraction less than 30%
    5.Coronary artery bypass surgery less than 6 weeks prior to the qualifying IVUS
    6.Cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication
    7.Uncontrolled severe hypertension: systolic blood pressure greater than 180 mmHg or diastolic blood pressure > 110 mmHg prior to randomization despite antihypertensive therapy
    8.Poorly controlled diabetes mellitus and an HbA1c greater than 10.0% prior to randomization
    9.Active liver disease defined as any known current infectious, neoplastic or metabolic pathology of the liver OR unexplained alanine aminotransferase, aspartate aminotransferase, elevation greater than 2 × ULN OR total bilirubin elevation greater than1.5 × ULN at screening confirmed by a repeat measurement at least 1 week apart
    10.Fasting triglyceride value less than 400 mg/deciliter (dL)
    11.Impaired kidney function defined as calculated glomerular filtration rate less than 60 milliliter (mL)/min by Modification of Diet in Renal Disease formula. In addition, subjects with a 0.3 mg/dL or 25% increase in serum creatinine in the initial 3 to 5 days from presentation for ACS will be excluded from the study
    12.Serious comorbid disease in which the life expectancy of the subject is shorter than the duration of the trial (eg, acute systemic infection, cancer, or other serious illnesses). This includes all cancers with the exception of treated basal-cell carcinoma occurring greater than 3 years before screening
    13.Body weight greater than 120 kg or less than 20 kg
    14.Women who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least 2 methods of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long- term injectable contraception, intrauterine device or tubal ligation). Women who are greater than 2 years postmenopausal (defined as greater than or equal to 1 year since last menstrual period) AND if less than 55 years old with a negative pregnancy test within 24 hours of randomization or surgically sterile are exempt from this exclusion
    15.Men who are unwilling to use an acceptable method of birth control during the entire study period (ie, condom with spermicide)
    16.Previous participation in this study or any preceding study with ETC-216, MDCO-216, or similar investigational medicines containing apolipoprotein A-I (ApoA-I) proteins
    17.Known allergy to the phospholipid or any other component of the investigational product (dimeric rApoA-IM, 1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine, or mannitol and sucrose in phosphate buffer).
    18.Treatment with other investigational medicinal products or devices within 30 days or five half˗lives, whichever is longer
    19.Known history of alcohol and/or drug abuse within 5 years.
    20.Use of other investigational medicinal products or devices during the course of the study, excluding Post-Marketing Registries
    21.Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to:
    •Inappropriate for this study, including subjects who are unable to communicate or to cooperate with the investigator.
    •Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including subjects whose cooperation is doubtful due to drug abuse or alcohol dependency)
    •Unlikely to comply with the protocol requirements, instructions and study-related restrictions; eg, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study
    •Having any medical or surgical condition, which in the opinion of the investigator, would put the subject at increased risk from participating in the study
    •Subject is involved or a relative of someone directly involved in the conduct of the study
    E.5 End points
    E.5.1Primary end point(s)
    Change in PAV from baseline to Day 36 post randomization, as determined by IVUS
    E.5.1.1Timepoint(s) of evaluation of this end point
    baseline, D36
    E.5.2Secondary end point(s)
    •Change in TAV from baseline to Day 36 post randomization, as determined by IVUS
    •Change in TAV for the 10 mm subsegment with the greatest disease burden at baseline
    •Proportion of subjects in each group who demonstrate regression of coronary atherosclerosis, defined as reduction in PAV from baseline to Day 36 of more than two SD of the test/re-test variability.
    •Proportion of subjects in each group with regression of coronary atherosclerosis, defined as a change in PAV from baseline to Day 36 of less than zero (ie, any reduction in PAV)
    E.5.2.1Timepoint(s) of evaluation of this end point
    baseline, D36
    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 Yes
    E.6.5Efficacy Yes
    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 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 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 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 trial5
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Czech Republic
    Germany
    Hungary
    Netherlands
    New Zealand
    Poland
    Spain
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    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: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 Yes
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 296
    F.4.2.2In the whole clinical trial 600
    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)
    Standard of treatment
    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 Decision2016-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-07
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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