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    Summary
    EudraCT Number:2007-006445-41
    Sponsor's Protocol Code Number:CTSSTS1010207V2
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-23
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2007-006445-41
    A.3Full title of the trial
    The irreversibility of hemorrhagic shock treatment with anti-opiod neuropeptide
    TRATTAMENTO DELLA IRREVERSIBILITA' DELLO SHOCK EMORRAGICO CON NEUROPETIDI ANTI OPPIOIDI
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Hemorragic shock treatment
    Trattamento dello shock emorragico
    A.3.2Name or abbreviated title of the trial where available
    Stopshock
    Stopshock
    A.4.1Sponsor's protocol code numberCTSSTS1010207V2
    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 SponsorHEALTH RICERCAE SVILUPPO SRL
    B.1.3.4CountryItaly
    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 supportMinistero della Difesa Agenzia Industria Difesa Piano Nazionale di Ricerca Militare
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHealth Ricerca e Sviluppo Spin off University of Bologna
    B.5.2Functional name of contact pointHR&S - CTS SMD L 023
    B.5.3 Address:
    B.5.3.1Street AddressVia S Lucia 30
    B.5.3.2Town/ cityMassa Lombarda (Ra)
    B.5.3.3Post code48024
    B.5.3.4CountryItaly
    B.5.4Telephone number+39054581871
    B.5.5Fax number+390545978245
    B.5.6E-mailinfo@healthricercaesviluppo.it
    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 nameTetracosactide
    D.3.2Product code NA
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther use (Noncurrent)
    Intramuscular use
    Intravenous use
    Intraosseous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTETRACOSACTIDE
    D.3.9.1CAS number 16960-16-0
    D.3.9.2Current sponsor codeACTH 1-24
    D.3.9.4EV Substance CodeSUB10941MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number10
    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 typeSalva Vita
    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
    Mortality of hemorrhagic shock grade 2 and 3 is from 50 to '80% in the first 24 hours, and morbidity and mortality betrayed is to 7 to 8 days of' 90% for Acute Respiratory Distress Syndrome and / or Multiple Organ Failure. Survival percentage is inversely proportional to the time where you can intervene (1 hour / 10% - the Golden Hour)
    La mortalità da shock emorragico di grado 2 e 3 è dal 50 all' 80 % nelle prime 24 ore, nonché la morbilità e mortalità tardiva a 7 – 8 giorni è del' 90 % per Acute Respiratory Distress Syndrome e/o Multiple Organ Failure. La percentuale di sopravvivenza è inversamente proporzionale al tempo in cui si riesce ad ad intervenire (1 ora /10% : la Golden Hour)
    E.1.1.1Medical condition in easily understood language
    The severe bleeding triggered a dramatic systemic inflammatory response to irreversible shock. Who did not die ,has late complications and lethal within few days
    L'emorragia innesca una drammatica reazione infiammatoria sistemica fino allo shock irreversibile. Chi non muore , ha complicazioni tardive e letali entro pochi giorni
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10049771
    E.1.2Term Shock haemorrhagic
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Treatment of a life-saving kit casualties in hemorrhagic shock: a)reduction in mortality from hemorrhagic shock of grade 2 or 3 from 50 to 80% in the first 24 hours; b)reduction of morbidity and mortality betrayed to 7 - 8 days of '90% for Acute Respiratory Distress Syndrome and/or Multiple Organ Failure
    Trattamento salvavita di vittime in shock emorragico: a)riduzione della mortalità per shock emorragico di grado 2 e 3 al 50 all' 80 % nelle prime 24 ore; b)riduzione della morbilità e mortalità tradiva a 7 – 8 giorni dell' 90 % per Acute Respiratory Distress Syndrome e/o Multiple Organ Failure.
    E.2.2Secondary objectives of the trial
    Adjunct of the individual treatment of hemorrhagic shock in the pre-and intra-hospital emergencies and Critical Mass Events by war or natural cause also with self injector devices.
    Coadiuvante del trattamento individuale dello shock emorragico nelle emergenze pre ed intra ospedaliere e per Eventi Critici di Massa da causa naturale o bellica anche con siringhe autoiniettore
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patients of both sexes in hemorrhagic shock grade 2 and 3 (or Level III and IV) to be treated at pre-or intra-hospital filed
    Pazienti adulti di ambo i sessi in shock emorragico di grado 2 e 3 ( o livello III e IV ) da trattare a livello pre o intra- ospedaliero
    E.4Principal exclusion criteria
    1. Poisonings, hangings, drownings and asphyxiations; 2. Any patient attended at the incident scene by a non-BASICS doctor and where the intravenous fluids protocol of the attending paramedic will be recorded as having been overridden by that doctor; 3. Patients dead at the scene before the ambulance arrived and who remained without vital signs for the duration of the prehospital phase of care; 4. Patients with superficial skin injuries, including simple penetrating injuries. 5. Any patient with burns; 6. Any patient whose trauma diagnosis on admission will be an isolated fractured neck of femur or single pubic rami fracture, whether or not they died; 7. Patients whose trauma diagnosis on admission will be an isolated simple facial injury, including simple eye injuries; 8. Patients whose trauma diagnosis on admission will be a simple spinal sprain (i.e. acute cervical, thoracic or lumbar sprain with no fracture or dislocation). 9. Patients involved in major incidents', as not defined by each individual ambulance service; 10. Any trauma patient aged or apparently aged less than 18 years; 11. Any female trauma patient known to be or apparently pregnant; 12. Any patient attended by a crew that had only an emergency medical technician or a paramedic qualified for less than 1 year and not randomly allocated to a treatment branch.
    1.Avvelenamenti, annegamenti ed asfissie; 2. Qualsiasi paziente non assistito dai team autorizzati; 3. I pazienti morti alla scena prima dell' arrivo dell'ambulanza e/o con funzioni vitali assenti durante la fase di trasporto in opspedale; 4. Pazienti con le lesioni superficiali della pelle, compreso le ferite penetranti semplici; 5. Qualsiasi paziente con ustioni; 6. Qualsiasi paziente di cui la diagnosi di trauma all' ammissione sarà una frattura semplice del collo del femore o frattura pubica o di arti; 7. Pazienti di cui la diagnosi di trauma sull'ammissione sarà una lesione facciale isolata, compreso le lesioni semplici agli occhi ; 8. Pazienti di cui la diagnosi di trauma all'ammissione sarà una distorsione lombare spinale semplice (cioè cervicale , toracica o senza la frattura o la dislocazione di ossa). 9. Pazienti di incidenti di maggiori ma non definiti da ogni servizio di individuale delle ambulanze; 10. Tutto il paziente con trauma che sono o sembrano apparentemente con meno di 18 anni; 11. Qualsiasi paziente femminile traumatizzata in stato di gravidanza sospetta o conosciuta; 12. Qualsiasi paziente assistito da una squadra che ha come personale medico o da un paramedico qualificato con esperienza per meno di 1 anno e non allocato al braccio del trattamento
    E.5 End points
    E.5.1Primary end point(s)
    Validation of tetracosactide dose of 10 mg as an important adjunct in the treatment of shock grade 2 and 3 as support for pre-and intra hospital emergencies
    Validazione del tetracosactide a dosaggio di 10 mg come adiuvante importante nel trattamento dello shock di grado 2 e 3
    E.5.1.1Timepoint(s) of evaluation of this end point
    Significant reduction of plasma specific biological components of hemorrhagic shock when initiating the process of stabilization (T0_T24 hours) using the following plasma assays: TNF alpha, TNF beta, IL6, IL10; IFgamma; VEGF, Flt3 ligand, fractalkine, PDGF; selectin; sICAM-1; sVCMA-1
    Riduzione significativa delle componenti biologiche plasmatiche specifiche per lo shock emorragico da quando si instaura al processo di stabilizzazione (T0_T24 ore) mediante i seguenti dosaggi plasmatici: TNF alfa; TNF beta; IL6;IL10; IFgamma;VEGF; Flt3 ligand; fractalkine; PDGF; Selectin; sICAM-1; sVCMA-1
    E.5.2Secondary end point(s)
    Validation of treatment with ACTh 1-24 for resuscitation and stabilization of the victim in hemorrhagic shock after trauma / surgical bleeding on the field or on scene, in pre and in hospital emergencies, particularly in the critical mass events (acts of terrorism, war, disasters, etc..) that involved in a brief window of time high-volume emergency services and limited land resources.
    Validazione del trattamento per la rianimazione e la stabilizzazione della vittima in shock emorragico post traumatico/ sanguinamento chirurgico sul campo o sulla scena, nelle emergenze pre ed intra ospedaliere e in particolare negli eventi critici di massa (atti di terrorismo, eventi bellici, catastrofi etc.) che coinvolgono in una breve finestra di tempo alti volumi di prestazioni di soccorso e limitate risorse territoriali.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Analysis of the relationship between scores on international standards for mortality and morbidity expected and that observed in relation to the clinical condition of the patient in shock and the treatment received: logistic EuroSCORE, Intensive Care Unit score, APAHCE II. All patients will be classified with the data base of SDO and Procedures SDO ICD9 CM
    Analisi delle relazione fra i punteggi standard internazionali per mortalità e morbilità attesa e quella osservata in rapporto alle condizioni cliniche del paziente in shock e al trattamento ricevuto: Euroscore logistico, Intensive Care Unit score, APAHCE II. Tutti i pazienti saranno classificati con la base di dati di SDO e Procedure di SDO ICD9 CM
    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 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
    save lives
    salva vita
    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) No
    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 Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Random non sui pazienti ma sul team professionale delle emergenze
    Randomization not on patiens but on the professional team
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Advanced Life Support; Tactical Emergency Medical
    Advanced Life Support,Tactical Emergency Medical
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    Statistically significant from a biological standpoint between the two groups for Level I evidence (U.S. Preventive Services Task Force PSTFAgency for Health Research Quality) Level A recommendations: evidence that the benefits outweigh the risks; Classification (1967 by Daniel Schwartz and Joseph Lellouch) as an explanatory study (explanatory trials); effective than ''the gold standard'' or ''standard therapy''
    Anche per interruzzione anticipata per Livello I di evidenza ( US PSTF for HRQ; Livello A di raccomandazioni : evidenza che i benefici siano maggiori dei rischi ;studio esplicativo di efficacia Versus the gold standard
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    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.1.1Number of subjects for this age range: 0
    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: 120
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-07-23. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women Yes
    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 in critical condition - coma- with not capable of consent
    Pazienti in condizioni critiche in coma non in grado d' intendere e volere
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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)
    Normal standard treatment after surgery or in Intensive Care Unit
    Normale trattamento standard dopo la chirurgia o in Unità di Terapia Intensiva
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Hospital Saint Georges
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-01-09
    P. End of Trial
    P.End of Trial StatusCompleted
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