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    The EU Clinical Trials Register currently displays   43841   clinical trials with a EudraCT protocol, of which   7281   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:2014-002440-41
    Sponsor's Protocol Code Number:CO-ILEPSS
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-02
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2014-002440-41
    A.3Full title of the trial
    Safety and efficacy of iloprost and eptifibatide co-administration compared to standard therapy in patients with septic shock – a randomized, controlled, double-blind investigator-initiated trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    NA
    A.3.2Name or abbreviated title of the trial where available
    CO-ILEPSS
    A.4.1Sponsor's protocol code numberCO-ILEPSS
    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 SponsorRigshospitalet, Capital Region Bloodbank 2034, Section for Transfusion Medicine
    B.1.3.4CountryDenmark
    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 supportRigshospitalet
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRigshospitalet, Capital Region Bloodbank 2034, Section for Transfusion Medicine
    B.5.2Functional name of contact pointSponsor (Sisse Ostrowski)
    B.5.3 Address:
    B.5.3.1Street AddressBlegdamsvej 9
    B.5.3.2Town/ cityCopenhagen Ø
    B.5.3.3Post code2100
    B.5.3.4CountryDenmark
    B.5.4Telephone number004524430464
    B.5.5Fax number004535390038
    B.5.6E-mailsisse.ostrowski@gmail.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 Yes
    D.2.1.1.1Trade name INTEGRILIN 2 mg/ml infusionsvæske, opløsning
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxo Group Ltd
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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.3.4Pharmaceutical form 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 INNEPTIFIBATIDE
    D.3.9.1CAS number 188627-80-7
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB12498MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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.IMP: 2
    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 ILOMEDIN, Concentrate for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Schering Pharma
    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.3.4Pharmaceutical 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 INNILOPROST TROMETAMOL
    D.3.9.1CAS number 0
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB14185MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number27
    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 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
    Septic shock
    E.1.1.1Medical condition in easily understood language
    Blood poisoning
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10040070
    E.1.2Term Septic shock
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluating the safety and efficacy of iloprost and eptifibatide co-administration compared to placebo as an addition to standard care in septic shock patients.
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult intensive care patients (age ≥18 years)
    AND
    2. Sepsis, defined as suspected or confirmed site of infection or positive blood culture and ≥2 of 4 systemic inflammatory response syndrome (SIRS) criteria fulfilled within the last 24h:
    a) Temperature ≤ 36˚ C or ≥ 38˚C
    b) Heart rate ≥ 90 beats per minute
    c) Mechanical ventilation for acute respiratory process or respiratory rate ≥ 20 breaths per min or PaCO2 < 4.2kPa
    d) WBC ≥ 12,000/mm³ OR ≤ 4,000/mm³ OR > 10% bands
    AND
    3. Septic shock within the last 24h, defined as:
    a. Hypotension (MAP <70 mmHg, Lactate 4 mmol/L) despite ongoing resuscitation with fluids (crystalloids, colloids, blood products) within the last 24h OR
    b. ≥30 ml/kg ideal body weight (IBW) fluid (crystalloids, colloids, blood products) given in the last 24h AND
    c. Need for vasopressor/inotropic agents (noradrenaline, adrenaline, dopamine) within the last 24h
    AND
    4. Can be randomized into trial and dosed < 24 hours after septic shock diagnosis (the time-point for the septic shock diagnosis corresponds to the time-point where the vasopressor/inotropic therapy (3c) is initiated)
    AND
    5. Consent is obtainable
    E.4Principal exclusion criteria
    1. Patient is pregnant or breast-feeding
    2. Patient weights more than 125 kg
    3. Patients with known allergy towards any of the investigational products or contraindications which
    should be excluded according to the investigational product specifications
    4. Patients in whom the clinician finds antithrombotic therapy contraindicated - prophylaxis included
    5. Patients at increased risk of bleeding:
    a. Surgery in the previous 48 hours and expected surgery within 48 hours
    b. Epidural or spinal puncture in the previous 12 hours
    c. Platelet count less than 10,000/mm3 in the previous 24 hours
    d. Need of blood products for bleeding in the previous 24 hours (3 or more RBC/24 h)
    e. Treatment with any antithrombotics within 12 hours (profylaxis excepted)
    f. Current intracranial bleeding
    g. Traumatic brain or spinal injury within the last month
    6. Patients requiring any form of antithrombotics (beyond profylaxis) in therapeutic doses or
    prothrombotics in any dose, including:
    a. Unfractionated heparin within 8 hours before the infusion (prophylactic heparin up to 15,000 U/day permitted)
    b. LMWH within 12 hours before the infusion (prophylactic doses permitted)
    c. Warfarin within 1 day before the infusion
    d. Acetylsalicylic acid more than 650 mg/day within 3 days before the study
    e. Thrombolytic therapy within 3 days before the study (catheter clearance doses permitted)
    f. GPIIb/IIIa receptor inhibitors within 4 days before the study
    g. Antithrombin III with dose greater than 10,000 U within 12 hours before the study
    7. Patients with a do-not-resuscitate order (expected not to survive more than few days because of uncorrectable medical or surgical condition other than sepsis)
    8. Patient with chronic renal failure requiring dialysis (renal failure without need for dialysis permitted)
    9. Patients who have undergone transplantation of bone marrow, liver, pancreas, heart, lung, or bowel (kidney transplant permitted)
    10. Patient with known hypercoagulable condition:
    a. Activated protein C resistance
    b. Hereditary protein C, protein S, or antithrombin III deficiency
    c. Anticardiolipin or antiphospholipid antibody
    d. Lupus anticoagulant
    e. Homocysteinemia
    f. Recent or highly suspected pulmonary embolism or deep venous thrombosis (within 3 months)
    11. Patients with known congenital hypocoagulable diseases
    12. Patient with known primary pulmonary hypertension
    E.5 End points
    E.5.1Primary end point(s)
    * Change in biomarkers indicative of endothelial activation and damage from baseline to 48 hours post-randomization
    * Change in platelet count from baseline to 48 hours post-randomization
    * Change in D-dimer and fibrin split products indicative of fibrinolysis from baseline to 48 hours post-randomization
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours post-randomization
    E.5.2Secondary end point(s)
    * Severe bleeding (intracranial or clinical bleeding with the use of 3 RBC units or more/24 hours)
    * Use of blood products (in ICU) post-randomization
    * Difference in day 7, 30 and 90 day mortality between patients receiving active treatment and placebo
    * Changes in SOFA score from baseline to 48 h and day 5 and 7 post-randomization
    * Days of vasopressor, ventilator and renal replacement therapy post-randomization
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoint are evaluated througout the 48 hour treatment period and after 7, 30 and 90 days
    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 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 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
    All patients who withdraw from the trial for any reason and at any time
    should have an end of trial examination. Patients will be examined for
    any status changes that require further follow-up. All withdrawn
    patients will be followed-up as the remaining patients in the trial. If
    consent is withdrawn, the person making the withdrawal will be asked
    for permission to follow up for 90 days after randomisation.
    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 months0
    E.8.9.1In the Member State concerned 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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients are at the investigator site in a critical acute condition resulting in mental impairment or sedation, therefore scientific guardians will co-sign the informed consent form. Next-of-kin and the patients' general practitioner will co-sign.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    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
    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 Decision2014-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-08-11
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