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    Summary
    EudraCT Number:2015-005600-28
    Sponsor's Protocol Code Number:EBI-CABG
    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:2016-02-11
    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 number2015-005600-28
    A.3Full title of the trial
    Randomized double blind placebo-controlled phase II study on the effects of EA-230 on the innate immune response following on-pump cardiac surgery
    Gerandomiseerde dubbel blinde placebo gecontroleerde studie naar de effecten van EA-230 op de respons van het aangeboren immuun systeem na cardiale chirurgie met pomp
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the effects of EA-230 on the immune system following heart surgery
    Studie naar de effecten van EA-230 op het afweersysteem na een hart operatie
    A.3.2Name or abbreviated title of the trial where available
    Immunomodulation of EA-230 following on-pump CABG
    Immunomodulatie van EA-230 na CABg met pomp
    A.4.1Sponsor's protocol code numberEBI-CABG
    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 SponsorExponential Biotherapies Inc.
    B.1.3.4CountryNetherlands
    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 supportExponential Biotherapies Inc.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud University Medical Center
    B.5.2Functional name of contact pointRoger van Groenendael
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein 10
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6500 HB
    B.5.3.4CountryNetherlands
    B.5.6E-mailr.vangroenendael@radoudumc.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 New pharmaceutical compound. The answer on section D2.1 should be "no". But due to persisting error in the form, this answer could not be entered. This error had been notified to the service desk of ema, without satisfactory result.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.2Product code EA-230
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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 Yes
    D.3.11.13.1Other medicinal product typeEA-230 is a linear tetramer peptide with the sequence AQGV. A family of small peptides related to the core loop-2 region of the B-chain of hCG. EA-230 is manufactured by chemical synthesis.
    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 placeboInfusion
    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
    Systemic inflammatory respons (SIRS) and associated acute kidney injury (AKI)
    systemische inflammatoire respons (SIRS) en daaraan gerelateerde acute nierschade
    E.1.1.1Medical condition in easily understood language
    inflammatory response and kidney damage
    Ontstekingsreactie en nier schade
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    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 assess safety and tolerability of EA-230 in patients undergoing cardiac surgery with cardiopulmonary bypass.
    To assess the anti-inflammatory effect of EA-230 in patients with systemic inflammation following cardiac surgery.
    Het vaststellen van de veiligheid en verdraagzaamheid van EA-230 in patienten die een open hart operatie met cardiopulmonale bypass ondergaan.
    Het vaststellen van de ontstekingsremmende werking van EA-230 in deze patientengroep.
    E.2.2Secondary objectives of the trial
    To assess the effects on clinical outcomes in this patient group.
    Het vaststellen van de effecten van EA-230 op klinische uitkomsten in deze patientengroep.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients scheduled for elective on-pump CABG surgery, with or without valve replacement
    2. Written informed consent to participate in this trial prior to any study-mandated procedure.
    3. Patients aged >18, both male and female.
    4. Patients have to agree to use a reliable way of contraception with their partners from study entry until 3 months after study drug administration.
    1. Patienten die ingepland zijn voor een electieve CABG opeatie met of zonder klep vervanging en waarbij gebruikt wordt gemaakt van cardiopulmonale bypass

    2. informed consent voorafgaand aan de studieprocedures

    3. Patienten zijn 18 jaar en ouder, man of vrouw

    4. Patienten stemmen ermee in om een betrouwbare manier van anticonceptie te gebruiken met hun partner vanaf deelname aan de studie tot 3 maanden daarna.
    E.4Principal exclusion criteria
    1. Immune compromised
    • Solid organ transplantation
    • Known HIV
    • Pregnancy
    • Systemic use of immunosuppressive drugs
    2. Non-elective/Emergency surgery
    3. Hematological disorders
    • Known disorders from myeloid and/or lymphoid origin
    • Leucopenia (leucocyte count < 4x10^9/L)
    4. Use of iohexol contrast <48 hours before start of the first study procedure
    5. Known hypersensitivity to any excipients of the drug formulations used
    6. Treatment with investigational drugs or participation in any other intervention clinical trial within 30 days prior to study drug administration
    7. Inability to personally provide written informed consent (e.g. for linguistic or mental reasons)
    8. Known or suspected of not being able to comply with the trial protocol.
    1. Immuun gecompromitteerd

    • Orgaan transplantatie

    • HIV positief

    • Zwangerschap

    • Systemsch gebruik van immunosuppressiva

    2. Non-electieve/ Spoed operatie

    3. Hematologische stoornissen

    • Bekende stoornis van myeloide en/of lymphoide origine

    • Leukopenie (leukocyten aantal < 4x10^9/L)

    4. Gebruik van Iohexol contrastmiddel <48 uur voor de eerste studie procedure

    5. Bekende overgevoeligheid voor bestandsdelen in de medicijnen die tijdens de studie gebruikt zullen worden.

    6. Deelname aan een andere klinische interventie studie en/of behandeling met een studie medicijn in de 30 dagen voorafgaand aan deelname.

    7. Niet in staat zijn persoonlijk een geschreven informed consent te geven.

    8. Vermoeden of de wetenschap dat de patient niet in staat is om het protocol na te leven.
    E.5 End points
    E.5.1Primary end point(s)
    Safety:
    • Adverse events
    • Vital signs (blood pressure and heart rate)
    • Safety laboratory parameters (Hb, Ht, leucocytes, thrombocytes, leucocyte differential blood count, sodium, potassium, creatinine, urea, alkaline phosphatase, ALT, AST, γGT, CK, CRP)

    Key-efficacy endpoints:
    • Blood plasma levels of IL-6
    • GFR measured by plasma clearance of iohexol
    Veiligheid:
    • Bijwerkingen
    • Vitale parameters (bloed druk en hartfrequentie)
    • Laboratorium veiligheidsparameters (Hb, Ht, leukocytes, thrombocytes, leukocyten differentiatie, natrium, kalium, creatinine, ureum, AF, ALAT, ASAT, γGT, CK, CRP)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse events: Continous form start study till end of study (90days)
    Vital signs: During treatment and hospital stay
    Safety laboratory parameters:During treatment and hospital stay

    Blood plasma levels of IL-6: Baseline, start ECC pump, stop ECC pump, t=2 hours after stop ECC pump, t=4 hours after stop ECC pump, t=6 hours after stop ECC pump, t=24 hours after stop ECC pump
    GFR measured by plasma clearance of iohexol: Day before surgery and day after surgery
    Bijwerkingen: van start tot einde van de studie (90 dagen)
    Vitale parameters: Gedurende de ziekenhuisopname
    Laboratorium parameters:Gedurende de ziekenhuisopname

    IL-6 plasma: Baseline, start ECC pomp, stop ECC pomp, t=2 uur na stop ECC pomp, t=4 uur na stop ECC pomp, t=6 uur na stop ECC pomp, t=24 uur na stop ECC pomp
    GFR dmv iohexol klaring: Dag voor en dag na operatie
    E.5.2Secondary end point(s)
    Inflammatory
    • Plasma levels of other cytokines: TNFα, IL-8, IL-10, IL-1RA, MCP-1, IL12-p70, MIP1α , MIP1β
    • Body temperature
    • SIRS score
    • SOFA score
    Outcome
    • Length of stay (ICU and general)
    • 90 days mortality
    • Apache score
    Renal:
    • Creatinine clearance using urine and plasma creatinine
    • Urine markers: KIM-1, NGAL, L-FABP, TIMP-2*IGFBP-7
    • Urine output (per 4 hrs during ICU-length of stay )
    • Urine biochemistry: Urea, sodium, Creatinine
    • Incidence of AKI stages, according to RIFLE-criteria
    • Need for Renal replacement therapy (RRT) and days of RRT
    Cardiovascular
    • Vasopressor use, expressed as inotropic score
    • Fluid therapy
    Pulmonary
    • Time until detubation
    • A-a O2gradient
    Pharmacokinetics
    • Blood plasma levels of EA-230 and, AUC, Cmax, terminal t1/2, Cl, V.
    Key-secundaire uitkomstmaten:
    • IL-6 plasma level

    Inflammatoir:
    • Plasma cytokines: TNFα, IL-8, IL-10, IL-1RA, MCP-1, IL12-p70, MIP1α , MIP1β
    • Lichaamstemperatuur
    • SIRS score
    • SOFA score
    Outcome
    • Opname duur (IC en algemeen)
    • 28 en 90 dagen mortaliteit
    • Apache score
    • Grote klinische events (Myocard infarct, beroerte, re-thoracotomy, heropname, pleurale en/of pericard punctie)
    Renal:
    • GFR bepaald dmv plasma klaring van iohexol
    • Endogenene creatinine klaring
    • Urine markers: KIM-1, NGAL, L-FABP, TIMP-2*IGFBP-7
    • Urine productie (per 4 uur gedurende de IC opname)
    • Urine biochemie: Ureum, natrium, Creatinine
    • Incidentie van AKI stages, volgens de RIFLE-criteria
    • Gebruik van niervervangende therapie en het aantal dagen hiervan
    Cardiovasculair
    • Vasopressor gebruik, uitgedrukt in de inotropie score
    • Vocht therapie
    Pulmonair
    • Tijd tot detubatie
    • A-a O2 gradient
    Pharmacokinetiek
    • Bloed plasma levels van EA-230 en Cmax, t1/2, Cl, V.
    E.5.2.1Timepoint(s) of evaluation of this end point
    cytokines: BBaseline, start ECC pomp, stop ECC pomp, t=2 uur na stop ECC pomp, t=4 uur na stop ECC pomp, t=6 uur na stop ECC pomp, t=24 uur na stop ECC pomp
    Lichaamstemperatuur, SIRS score, SOFA score, opname duur (ICU en algemeen), mortaliteit, Apache score, Creatinine klaring, Incidentie van AKI, niervervangende therapie: Gedurende ziekenhuisopname
    Urine markers en biochemie: dga na operatie
    Urine productie, vocht therapie, Vasopressor gebruik, tijd tot detubatie, A-a O2gradient: gedurende ICU-opname
    Pharmacokinetiek: Frequente sampling gedurdende studie medicatie behandeling tot 2 uur na stop van de infusie.
    cytokines: Baseline, start ECC pump, stop ECC pump, t=2 hours after stop ECC pump, t=4 hours after stop ECC pump, t=6 hours after stop ECC pump, t=24 hours after stop ECC pump
    Body temperature, SIRS score, SOFA score, Length of stay (ICU and general), mortality, Apache score, Creatinine clearance, Incidence of AKI, RRT : During treatment and hospital stay
    Urine markers and biochemistry: day after surgery
    Urine output, Fluid therapy, Vasopressor use, Time until detubation, A-a O2gradient: during ICU-length of stay
    Pharmacokinetics: Frequent sampling during study drug administration until 2 hours after stop of study drug.
    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 Yes
    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) Yes
    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 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 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 years1
    E.8.9.1In the Member State concerned months6
    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: 160
    F.1.3Elderly (>=65 years) No
    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 state160
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-22
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