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    Summary
    EudraCT Number:2018-001613-33
    Sponsor's Protocol Code Number:IgM-FAT
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-18
    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 number2018-001613-33
    A.3Full title of the trial
    Efficacy and safety of adjunctive IgM-enriched immunoglobulin therapy with a personalized dose based on serum IgM-titers vs. standard dose in patients with septic shock. A multicenter, interventional, randomized, single-blinded, two arms, adaptive study design
    Efficacia e sicurezza della terapia aggiuntiva con immunoglobuline arricchite in IgM, basata sui livelli sierici di IgM, rispetto ad un trattamento con dose standard di immunoglobuline arricchite in IgM in pazienti con shock settico. Studio multicentrico, interventistico, randomizzato in singolo cieco con due bracci, adattabile
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study evaluating the efficacy and safety of IgM-enriched immunoglobulin therapy with a personalized dose based on serum IgM-titers vs. IgM-enriched immunoglobulin standard dose in patients with septic shock
    Studio clinico che valuta l’efficacia e la sicurezza della terapia con immunoglobuline arricchite in IgM basata sui livelli di IgM nel siero rispetto ad un trattamento con dose standard di immunoglobuline arricchite in IgM in pazienti con shock settico
    A.3.2Name or abbreviated title of the trial where available
    IgM-FAT (Flat Against Titrated)
    IgM-FAT (Flat Against Titrated)
    A.4.1Sponsor's protocol code numberIgM-FAT
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA
    B.1.3.4CountryItaly
    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 supportBIOTEST AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera-Universitaria di Modena
    B.5.2Functional name of contact pointTerapia intensiva, Dipartimento di
    B.5.3 Address:
    B.5.3.1Street AddressL.go del Pozzo 71
    B.5.3.2Town/ cityModena
    B.5.3.3Post code41124
    B.5.3.4CountryItaly
    B.5.4Telephone number0594224896
    B.5.5Fax number0594224899
    B.5.6E-mailemanuela.biagioni@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 PENTAGLOBIN - 50 MG/ML SOLUZIONE PER INFUSIONE 1 FLACONE DA 50 ML
    D.2.1.1.2Name of the Marketing Authorisation holderBIOTEST PHARMA GMBH
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameImmunoglobuline policlonali arricchite in IgM
    D.3.2Product code [Immunoglobuline policlonali arricchite in IgM]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNImmunoglobuline policlonali arricchite in IgM
    D.3.9.1CAS number 97794-27-9
    D.3.9.2Current sponsor codePentaglobin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Septic shock
    Shock settico
    E.1.1.1Medical condition in easily understood language
    Septic shock
    Shock settico
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10040580
    E.1.2Term Shock septic
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10040070
    E.1.2Term Septic shock
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    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
    The primary objective is to verify the hypothesis that an adjunctive therapy with IgM-enriched immunoglobulin with a personalized dose based on serum IgM-titers is more effective in reducing any-cause mortality in patients with septic shock compared to a flat dose therapy. Mortality will be measured at 28 days after patient radomization.
    Verificare l’ipotesi che, in pazienti con shock settico e bassi livelli di immunoglobuline entro 24 ore dalla comparsa dello shock, una terapia aggiuntiva con immunoglobuline policlonali endovenose arricchite in IgM somministrata in dosaggi personalizzati basati sulla concentrazione sierica giornaliera di IgM sia più efficace nel ridurre la mortalità per ogni causa rispetto alla somministrazione in dosi standard. Il tasso di mortalità verrà misurato a 28 giorni dopo la randomizzazione.
    E.2.2Secondary objectives of the trial
    To evaluate:
    - All cause mortality at Intensive Care Unit (ICU) discharge, hospital discharge and at day 90
    - Occurrence of new organ dysfunction and grade of dysfunction during ICU stay
    - ICU free hours (IFHs) at day 28
    - Hospital free days (HFDs) at day 90
    - Ventilation free days (VFDs) at day 28
    - Vasopressors free-days (VasoFDs) at day 28
    - Antibiotic free days (AFDs) at day 28
    - ICU acquired weakness at 7, 28 and 90 days or hospital discharge defined by Medical Research Council (MRC) Scale
    - Occurrence of protocol related adverse events at day 28
    Valutare:
    - Mortalità alla dimissione dalla terapia intensiva, alla dimissione ospedaliera e a 90 giorni
    - Insorgenza di nuove disfunzioni d’organo e grado delle disfunzioni d’organo durante tutto il periodo di studio
    - Ore libere dalla terapia intensiva al giorno 28
    - Giorni liberi da ospedalizzazione al giorno 90
    - Giorni liberi da ventilazione al giorno 28
    - Giorni liberi da farmaci vasoattivi al giorno 28
    - Giorni liberi da antibiotici al giorno 28
    - Debolezza muscolare acquisita in terapia intensiva al giorno 7, 28 e 90 definita dalla scala MRC (Medical Research Council)
    - Incidenza di eventi avversi correlati al farmaco sperimentale e alle procedure dello studio al giorno 28
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > 18 years;
    - Septic shock occurrence < 24 hours; septic shock is identified according to Sepsis-3 definition by a vasopressor requirement to maintain a mean arterial pressure of 65 mm Hg or greater and serum lactate level greater than 2 mmol/L (>18 mg/dL) in the absence of hypovolemia in patients with sepsis. Sepsis is defined as a life threatening organ dysfunction identified as an acute change in total SOFA score greater or equal to 2 points consequent to the infection;
    - IgM-titers < 60mg/dl (or < 20% of the lower threshold value of local laboratory) within 24 hours from shock occurrence.
    - Età maggiore di 18 anni;
    - Segni di shock settico per meno di 24 ore in pazienti con sepsi. La sepsi è definita come disfunzione d’organo potenzialmente mortale identificata come un cambiamento acuto del SOFA score maggiore o uguale a 2 punti in conseguenza all’infezione;
    - Livelli sierici di IgM< 60mg/dl o inferiori di almeno il 20% al limite inferiore di normalità del laboratorio di riferimento entro 24 ore dallo shock settico.
    E.4Principal exclusion criteria
    - Shock of uncertain diagnosis;
    -Hypersensitivity to IgM Preparation in use or its excipients;
    - Patients receiving intravenous immunoglobulins (e.g. IgG or IgM enriched preparations) for > 6 hours before enrolment;
    - Selective absolute IgA deficiency with antibodies to IgA;
    - Pregnancy or breastfeeding or positive pregnancy test. In childbearing age women, before inclusion, a pregnancy test will be performed if not available;
    - Clinical decision to withhold life-sustaining treatment or “too sick to benefit”;
    - Neutrophil count <1.000/mm3;
    - Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition);
    - Patients with a known, chronic kidney dysfunction needing dialysis (creatinine greater or equal to 3.4 mg/dl or creatinine clearance lower or equal to 30 ml/min/1.73m2);
    - Body Mass Index (BMI) >40;
    - Participation in other clinical trials on adjunctive therapies for sepsis (during past 3 months);
    - Lack or withdrawal of informed consent.
    - Shock di diagnosi incerta;
    - Ipersensibilità alla preparazione in uso o ai suoi eccipienti;
    - Pazienti che hanno ricevuto immunoglobuline endovenose per più di 6 ore prima dell’arruolamento nello studio;
    - Deficit assoluto selettivo di IgA con anticorpi anti-IgA;
    - Gravidanza o allattamento al seno o test di gravidanza positivo. Nelle donne in età fertile verrà effettuato un test di gravidanza prima dell’inclusione dello studio;
    - Decisione clinica di interrompere i trattamenti di sostegno vitale o pazienti troppo gravi per beneficiare del trattamento;
    - Conta dei granulociti neutrofili <1.000/mm;
    - Presenza di altre malattie gravi in grado di ridurre l’aspettativa di vita (es. pazienti per i quali non ci si aspetta una sopravvivenza a 28 giorni a causa della loro condizione medica preesistente non correggibile);
    - Pazienti con nota insufficienza renale cronica con necessità di dialisi (Creatinina maggiore o uguale a 3.4 mg/dl o clearence delle creatinina minore o uguale a 30 ml/min/1.73m2);
    - Indice di massa corporea (BMI) >40;
    - Partecipazione ad altri trial clinici sulle terapie aggiuntive per la sepsi (durante i 3 mesi precedenti);
    - Mancanza o ritiro del consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    All-cause mortality at day 28 after randomization.
    Mortalità per ogni causa al giorno 28 dalla randomizzazione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be assessed at day 28 after randomization.
    L'endpoint primario sarà valutato a 28 giorni dalla randomizzazione.
    E.5.2Secondary end point(s)
    All cause mortality at Intensive Care Unit (ICU) discharge, hospital discharge and at day 90.; Occurrence of new organ dysfunction and grade of dysfunction during ICU stay. Organ dysfunction is defined as a Sequential Organ Failure Assessment (SOFA) score greater or equal to 3 or a Multiple organ Failure (MOF) score greater or equal to 1 for the corresponding organ occurring after randomization, grade of dysfunction is measured with SOFA score and with MOF score daily from randomization to day 28.; ICU free hours (IFHs) at day 28, defined as the total number of hours between ICU discharge and day 28. If death occurs during the ICU stay before day 28 the ICU free
    hours calculation will be 0. The ICU readmission before day 28 after randomization will be considered.; Hospital free days (HFDs) at day 90, defined as the total number of days between Hospital discharge and day 90. If death occurs during the hospital stay before day 90 the hospital free days calculation will be 0. Hospital readmissions before day 90 after randomization will be considered; Ventilation free days (VFDs) at day 28, defined as the total number of days that patient is alive and free of ventilation between randomisation and day 28 (censored at hospital discharge). Periods of assisted breathing lasting less than 24 hours for surgical procedures will not count against the ventilation free days calculation.; Vasopressors free-days (VasoFDs) at day 28. VasoFDs is defined as the total number of days that patient is alive and free of vasopressors between randomisation and day 28 (censored at hospital discharge).; Antibiotic free days (AFDs) at day 28, defined as the total number of days that the patient is alive and free of antibiotic drugs administration between randomisation and day 28 (censored at hospital discharge).; ICU acquired weakness at 7, 28 and 90 days or hospital discharge defined by Medical Research Council (MRC) Scale.; Occurrence of protocol related adverse events (see chapter 5.2) at day 28 (safety endpoint).
    Mortalità per ogni causa alla dimissione dalla terapia intensiva, alla dimissione ospedaliera e a 90 giorni.; Insorgenza di nuove disfunzioni d’organo e grado delle disfunzioni d’organo durante tutto il periodo di studio. Le disfunzioni d’organo sono definite come la presenza di un punteggio SOFA (Sequential Organ Failure Assessment score) maggiore o uguale a 3 o di un punteggio MOF (multiple Organ Failure score) maggiore o uguale a 1 per l’organo corrispondente insorta dopo la randomizzazione, il grado della disfunzione è misurato con il punteggio SOFA score e MOF score giornalmente dalla randomizzazione al giorno 28.; Ore libere dalla terapia intensiva al giorno 28, definito come il numero totale di ore tra la dimissione dalla terapia intensiva ed il giorno 28. In caso di decesso durante il ricovero in terapia intensiva prima del giorno 28, il calcolo dei giorni liberi da terapia sarà considerato uguale a 0. Saranno calcolati anche i re-ricoveri in terapia intensiva avvenuti prima del giorno 28.; Giorni liberi da ospedalizzazione al giorno 90, definiti come numero totale di giorni tra la dimissione dall’ospedale ed il giorno 90. In caso di decesso durante il ricovero in ospedale prima del giorno 90 il calcolo dei giorni liberi dall’ospedale sarebbe 0. Saranno calcolati anche i re-ricoveri avvenuti prima del giorno 90.; Giorni liberi da ventilazione al giorno 28, definiti come il numero totale di giorni in cui il paziente è vivo e non necessita di ventilazione meccanica tra la randomizzazione ed il giorno 28. Periodi di ventilazione assistita di durata inferiore alle 24 ore per procedure chirurgiche non saranno calcolati.; Giorni liberi da farmaci vasoattivi al giorno 28, definiti come il numero totale di giorni in cui il paziente è vivo e non necessita di supporto emodinamico con farmaci vasoattivi tra la randomizzazione ed il giorno 28.; Giorni liberi da antibiotici al giorno 28, definiti come il numero totale di giorni in cui il paziente è vivo e non vengono somministrati farmaci antibiotici tra la randomizzazione ed il giorno 28.; Debolezza muscolare acquisita in terapia intensiva al giorno 7, 28 e 90 definita dalla scala MRC (Medical Research Council).; Incidenza di eventi avversi correlati al protocollo di studio al giorno 28 (endpoint di sicurezza).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The endpoint will be assessed at ICU discharge, hospital discharge and at day 90 from the randomization.; The endpoint will be assessed at day 28 after randomization.; The endpoint will be assessed at day 28 after randomization.; The endpoint will be assessed at day 90 after randomization.; The endpoint will be assessed at day 28 after randomization.; The endpoint will be assessed at day 28 after randomization.; The endpoint will be assessed at day 28 after randomization.; The endpoint will be assessed at hospital discharge or at 7, 28 and 90 days after randomization.; The safety endpoint will be assessed at day 28 after randomization.
    L’endpoint sarà valutato alla dimissione dalla terapia intensiva, alla dimissione ospedaliera e a 90 giorni dopo la randomizzazione.; L'endpoint sarà valutato al giorno 28 dalla randomizzazione.; L'endpoint sarà valutato al giorno 28 dalla randomizzazione.; L'endpoint sarà valutato al giorno 90 dalla randomizzazione.; L'endpoint sarà valutato al giorno 28 dalla randomizzazione.; L'endpoint sarà valutato al giorno 28 dalla randomizzazione.; L'endpoint sarà valutato al giorno 28 dalla randomizzazione.; L'endpoint sarà valutato il giorno della dimissione dall'ospedale o al giorno 7, 28 e 90 dalla randomizzazione.; L'endpoint di sicurezza sarà valutato al giorno 28 dalla randomizzazione.
    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) 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 No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned12
    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 Information not present in EudraCT
    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
    LVSV
    LVSV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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: 143
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 213
    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
    Incapable subjects; temporarily unconscious capable subjects
    Soggetti incapaci; soggetti capaci temporaneamente incoscienti
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state356
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 356
    F.4.2.2In the whole clinical trial 356
    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)
    Patients will be monitored and treated according to local clinical practice.
    I pazienti saranno seguiti e trattati in accordo alla pratica clinica locale.
    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 Decision2019-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-18
    P. End of Trial
    P.End of Trial StatusOngoing
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