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   43886   clinical trials with a EudraCT protocol, of which   7296   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:2011-002824-42
    Sponsor's Protocol Code Number:SPIRI-201
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-02-16
    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 number2011-002824-42
    A.3Full title of the trial
    A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety, Tolerability and Efficacy of Intravenous Bendavia™ (MTP-131) on Reperfusion Injury in Patients Treated with Standard Therapy Including Primary PCI and Stenting for ST-segment Elevation Myocardial Infarction
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the Effects of Bendavia in Reducing Heart Damage in Patients with Heart Attacks
    A.3.2Name or abbreviated title of the trial where available
    The EMBRACE-STEMI™ Trial
    A.4.1Sponsor's protocol code numberSPIRI-201
    A.5.4Other Identifiers
    Name:IND Number:105942
    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 SponsorStealth Peptides 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 supportStealth Peptides, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStealth Peptides, Inc.
    B.5.2Functional name of contact pointChiefMedicalOfficer
    B.5.3 Address:
    B.5.3.1Street Address1188 Centre Street
    B.5.3.2Town/ cityNewton Centre
    B.5.3.3Post codeMA02459
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019082351146
    B.5.5Fax number0016172242889
    B.5.6E-mailclinicaltrials@stealthpeptides.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 nameBendavia
    D.3.2Product code MTP-131
    D.3.4Pharmaceutical form Powder 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.3.9.1CAS number 736992-21-5
    D.3.9.2Current sponsor codeMTP-131
    D.3.9.3Other descriptive nameBendavia™
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 placeboPowder for solution 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
    Reperfusion injury in ST-segment Elevation Myocardial Infarction
    E.1.1.1Medical condition in easily understood language
    Heart attack
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10064345
    E.1.2Term ST segment elevation myocardial infarction
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the trial is to evaluate the impact of Bendavia on limiting the size of infarcted myocardium in patients with first time anterior wall ST-segment elevation myocardial infarction (STEMI) who have undergone successful reperfusion using primary percutaneous coronary intervention (PCI) and stenting.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the trial are to evaluate the impact Bendavia has in patients with acute, anterior wall STEMI on the following outcomes:
    • Microvascular dysfunction
    • The pharmacokinetics of Bendavia
    • Renal dysfunction through 30 days and 6 months post-PCI and stenting
    • Cardiac function through day 30+7 post-PCI
    • The incidence of immediate myocardial complications during the primary hospitalization
    • Biomarkers of congestive heart failure and systemic inflammation through 6 months
    • Long-term clinical outcome at 30+7 days and 6 months
    • To evaluate the safety and tolerability of a single intravenous infusion of Bendavia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age ≥18 and <85 years of age
    • The patient presents with first-time acute, anterior wall STEMI scheduled to undergo primary PCI and stenting
    • The patient has symptoms of cardiac ischemia of ≥10 minutes
    • The patient must demonstrate an anterior wall STEMI with >0.1 mV ST-segment elevation in at least two contiguous precordial leads (i.e., V1-V4) or presumed new left bundle branch block
    • The time from onset of symptoms of cardiac ischemia to the anticipated time of initial PCI balloon inflation does not exceed four (4) hours and it is anticipated that the door-to-balloon time will be <2 hours
    • For female patients of child-bearing potential, an adequate form of contraception must be adhered to prior to entry into the study and for a further 3 months after the follow-up visit. Adequate contraception is defined as the usage by the female patient of any form of hormonal contraception or intra-uterine device (which should be established prior to the start of the study) plus usage by one of the partners of an additional spermicide-containing barrier method of contraception. The use of a barrier method alone or reliance on abstinence is not considered adequate. Female patients of childbearing potential must have a negative serum pregnancy test prior to entry into the study.
    • Female patients not of childbearing potential (i.e. female patients who are postmenopausal at least 12 months since last regular menses, or have been surgically sterilized) are eligible to enter the study
    • For male patients with female partners of child-bearing potential, an adequate form of contraception must be adhered to prior to entry into the study and for a further 3 months after the post-study medical. Adequate contraception is defined as the usage by the female partner of any form of hormonal contraception or intra-uterine device (which should be established prior to the start of the study) plus usage by one of the partners of an additional spermicide-containing barrier method of contraception. The use of a barrier method alone or reliance on abstinence is not considered adequate.
    • Written informed consent obtained that strictly adheres to the written guidelines from the local Institutional Review Board (IRB)/ Ethical Committee (EC)
    E.4Principal exclusion criteria
    • Cardiogenic shock or maximal systolic blood pressure (BP) <80 mm Hg after fluid and/or vasopressor resuscitation on at least two consecutive readings
    • Ongoing vasopressor support
    • Uncontrolled hypertension defined as a systolic BP >180 mm Hg or a diastolic BP >110 mm Hg on at least two consecutive readings
    • Cardiac arrest or arrhythmia requiring prolonged (>5 minutes) chest compressions/ cardiopulmonary resuscitation (CPR)
    • Prior coronary artery bypass graft surgery (CABG)
    • Prior myocardial infarction (MI)
    • Implantable cardioverter-defibrillator (ICD) or permanent pacemaker (PPM) unless known to be MRI safe. The presence of an MRI-compatible pacemaker or other MRI-compatible hardware will not be a contraindication to participation in the trial.
    • Known left ventricular ejection fraction <30% prior to the qualifying infarct
    • History of clinically significant hepatic disturbance or chronic renal impairment at the time of admission
    • Cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the last 30 days
    • Any known disorder that is associated with immunologic dysfunction (e.g., cancer, lymphoma, a positive serologic test for the human immunodeficiency virus, or hepatitis) more recently than 6 months before presentation or the administration of immunosuppressive drugs within 10 days of the STEMI at doses expected to be associated with immunosuppression including high dose steroids (>2.5 mg/d hydrocortisone or equal potency of synthetic steroids), TNF-α blockers or methotrexate/azathioprine.
    • Any condition that, in the Investigator’s opinion, would prevent adherence to the requirements of the protocol including language barrier or current alcohol or drug abuse
    • Contraindications (including claustrophobia) to cardiac MRI at study entry
    • Participation in an investigational drug or device study within the 30 days prior to enrollment into the EMBRACE-STEMI Trial or anticipated within the next 4 days
    • Female patients who are pregnant or breastfeeding during the study or intend to within 30 days of receiving study drug
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the comparison between treatment groups of the area under the creatine kinase-MB (CK-MB) enzyme curve obtained over the initial 72 hours following the initial PCI procedure.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the duration of the study
    E.5.2Secondary end point(s)
    The secondary endpoints will include the following:
    • Comparison between treatment groups of the area under the troponin I enzyme curve obtained over the initial 72 hours following the PCI procedure
    • Comparison between treatment groups of the infarct size as measured by the volume of infarcted myocardium on the day 4±1 cardiac MRI
    • Comparison between treatment groups of the infarct size as measured by the ratio of the volume of infarcted myocardium to the volume of edematous myocardium on the day 4±1 cardiac MRI
    • Comparison between treatment groups of the day 4±1 and 30+7 myocardial structure and function on cardiac MRI
    • Comparison between treatment groups of the incidence of immediate myocardial complications
    • Calculation of the pharmacokinetic profile of Bendavia.
    • Comparison between treatment groups of the myocardial infarct size on day 30+7
    • Comparison between treatment groups of the laboratory markers for congestive heart failure and systemic inflammation over time
    • Comparison between treatment groups of the 30+7-day and 6-month incidence of the composite endpoint
    • Comparison between treatment groups of the serial measurements of renal function as measured by serum creatinine, estimated glomerular filtration rate, cystatin C, and BUN and the incidence of contrast-induced nephropathy post-PCI

    Safety endpoints will be:
    • Comparisons of the incidence and types of reported adverse events
    • Comparisons of the incidence of new myocardial infarction or need for target (i.e., culprit artery) vessel revascularization following the enrollment event
    • Comparisons of changes in blood pressure, heart rate and respiratory rate
    • Comparisons of changes in blood and urine chemistries and hematology profiles
    • Comparisons of the incidence of hyponatremia defined as drop in serum sodium to <135 mmol/dL during the initial PCI hospitalization
    • Comparison of the incidence of significant post-PCI arrhythmias
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the duration of the study
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    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 Yes
    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 trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Germany
    Hungary
    Poland
    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
    End of the trial is defined as last visit of last patient
    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 months3
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 140
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Acute patients with symptoms of cardiac ischemia
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 206
    F.4.2.2In the whole clinical trial 250
    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)
    Subjects will be treated within standard care in each country involved.
    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 Decision2012-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-02-10
    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-Tue May 21 23:05:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA