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    Summary
    EudraCT Number:2020-005242-41
    Sponsor's Protocol Code Number:RF-2019-12370834
    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:2021-05-20
    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 number2020-005242-41
    A.3Full title of the trial
    FIBRINOGEN REPLACEMENT TO PREVENT INTRACRANIAL HAEMORRHAGE IN ISCHEMIC STROKE PATIENTS AFTER THROMBOLYSIS: A PILOT PROBE RANDOMIZED CONTROLLED TRIAL
    SOMMINISTRAZIONE DI FIBRINOGENO PER LA PREVENZIONE DELL’EMORRAGIA CEREBRALE POST-TROMBOLISI NEI PAZIENTI CON ICTUS ISCHEMICO: TRIAL RANDOMIZZATO PILOTA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    FIBRINOGEN REPLACEMENT TO PREVENT INTRACRANIAL HAEMORRHAGE IN ISCHEMIC STROKE PATIENTS AFTER THROMBOLYSIS: A PILOT PROBE RANDOMIZED CONTROLLED TRIAL
    SOMMINISTRAZIONE DI FIBRINOGENO PER LA PREVENZIONE DELL’EMORRAGIA CEREBRALE POST-TROMBOLISI NEI PAZIENTI CON ICTUS ISCHEMICO: TRIAL RANDOMIZZATO PILOTA
    A.3.2Name or abbreviated title of the trial where available
    FibER
    FibER
    A.4.1Sponsor's protocol code numberRF-2019-12370834
    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 USL DI BOLOGNA
    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 supportMinistero della Salute
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda USL di Bologna
    B.5.2Functional name of contact pointAzienda USL di Bologna
    B.5.3 Address:
    B.5.3.1Street AddressLargo Nigrisoli 2
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40133
    B.5.3.4CountryItaly
    B.5.4Telephone number0516225205
    B.5.6E-maila.zini@ausl.bologna.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 Yes
    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 nameRIASTAP
    D.3.2Product code [040170021]
    D.3.4Pharmaceutical form Powder and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN00130750
    D.3.9.2Current sponsor codeB02BB01
    D.3.10 Strength
    D.3.10.1Concentration unit IU/g international unit(s)/gram
    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 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) No
    D.3.11.7Plasma derived medicinal product Yes
    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
    Ischemic stroke patients with secondary post-rtPA hypofibrinogenemia
    Pazienti con ictus ischemico sottoposti a trombolisi con rtPA che sviluppino ipofibrinogemia secondaria.
    E.1.1.1Medical condition in easily understood language
    Ischemic stroke patients with secondary post-rtPA hypofibrinogenemia
    Pazienti con ictus ischemico sottoposti a trombolisi con rtPA che sviluppino ipofibrinogemia secondaria.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10007948
    E.1.2Term Central nervous system haemorrhages and cerebrovascular accidents
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate if Fibrinogen replacement could prevent haemorrhagic complications in ischemic stroke patients with secondary post-rtPA hypofibrinogenemia.
    To evaluate the efficacy of fibrinogen infusion in stroke patients with secondary post-rtPA hypofibrinogenemia in:
    - sICH according NINDS, ECASS and SITS classifications.
    - extracerebral bleedings
    Valutare se la somministrazione di fibrinogeno umano per via endovenosa può prevenire le complicanze emorragiche nei pazienti con ictus ischemico sottoposti a trombolisi con rtPA che sviluppino ipofibrinogemia.
    Le definizioni degli obiettivi ed il prospetto metodologico riflettono quanto già approvato dal bando ricerca finalizzata 2019 (RF-2019-12370834) del Ministero della Salute.
    Valutare l’efficacia dell’infusione del fibrinogeno nella riduzione di
    - emorragia cerebrale sintomatica (symptomatic intracerebral hemorrhage, sICH) definita secondo i criteri di classificazione NINDS, ECASS e SITS;
    - emorragia extracerebrale.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of fibrinogen infusion in stroke patients with secondary post-rtPA hypofibrinogenemia:
    - Serious thromboembolic adverse events at 7 days after randomization (deep vein thrombosis, pulmonary embolism, myocardial infarct, recurrence of ischemic stroke, MACE defined as all-cause mortality, nonfatal myocardial infarction, andnonfatal stroke)
    To evaluate the efficacy of fibrinogen infusion in stroke patients with secondary post-rtPA hypofibrinogenemia in the clinical outcome defined as:
    - National Institutes of Health Stroke Scale score (NIHSS) at day 7
    - disability at 3 months, assessed with the modified Rankin Scale (mRS). Good outcome is considered as mRS 0-2
    - To evaluate the diagnosis of hyperfibrinolysis detected with Rotation thromboelastometry (ROTEM) in the whole ischemic stroke population randomized in the RCT (200 patients)
    - To correlate hyperfibrinolysis with cerebral bleeding in the whole ischemic stroke population and in each arm
    Valutare la sicurezza dell’infusione di fibrinogeno: frequenza di eventi tromboembolici severi nei 7 giorni successivi alla randomizzazione, inclusivi di trombosi venosa profonda, embolia polmonare, infarto miocardico, ictus ischemico o ricorrenza di ictus ischemico, eventi cardiovascolari maggiori (MACE) definiti come: mortalità da ogni causa, infarto miocardico non-fatale, ictus non-fatale nei primi 7 giorni successivi alla trombolisi
    Valutare l’outcome clinico, definito come: (i) NIHSS a 7 giorni e (ii) disabilità a 90 giorni, definita con la scala modificata di Rankin (modified Rankin scale, mRS), con outcome buono identificato come mRS 0-2.
    Valutare nella popolazione randomizzata la frequenza di iperfibrinolisi identificata con tromboelastogramma (ROTEM)
    Verificare eventuale correlazione tra iperfibrinolisi e ICH nella coorte randomizzata e nei rispettivi bracci di trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - patients with acute ischemic stroke treated with i.v. thrombolysis (rtPA 0,9 mg/Kg, 10% in bolus and 90% in infusion in 60
    minutes)
    - age >18 years
    - critical hypofibrinogenemia post-tPA, defined as a decrease of serum fibrinogen level <200 mg/dl and/or a rate decrease
    >50% than baseline level
    - written informed consent
    • Ictus ischemico acuto trattato con trombolisi endovenosa con rtPA 0.9 mg/kg (10% bolo e 90% infusione, in 60 min)
    • età>18 anni
    • presenza di ipofibrinogemia post-trombolisi a 2h o 6h, definita come riduzione del fibrinogeno a valori assoluti <200 mg/dl e/o con riduzione >50% rispetto al livello basale
    • consenso alla partecipazione
    E.4Principal exclusion criteria
    contraindication to rtPA treatment; patients who present symptomatic ICH during infusion of rt-PA
    • controindicazione a trattamento con rtPA
    • pazienti con emorragia cerebrale sintomatica durante la stessa infusione di rtPA
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy of fibrinogen infusion in stroke patients with secondary post-rtPA hypofibrinogenemia in reducing the rate of ICH defined as parenchymal hematoma (PH1, PH2 and remote ones)
    To evaluate the efficacy of fibrinogen infusion in stroke patients with secondary post-rtPA hypofibrinogenemia in:
    - sICH according NINDS, ECASS and SITS classifications.
    - extracerebral bleedings
    Valutare l’efficacia dell’infusione di fibrinogeno nella riduzione della frequenza di emorragia cerebrale (ICH), definita come ematoma cerebrale parenchimale (PH1, PH2, rPH1/rPH2).
    Valutare l’efficacia dell’infusione del fibrinogeno nella riduzione di
    - emorragia cerebrale sintomatica (symptomatic intracerebral hemorrhage, sICH) definita secondo i criteri di classificazione NINDS, ECASS e SITS;
    - emorragia extracerebrale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 hours after the rtPA infusion, or earlier in case of clinical deterioration, and on day 7 (or at discharge, if earlier).
    A 24h dall’infusione di rtPA, o prima in caso di peggioramento clinico, e al giorno 7 (o alla dimissione, se prima).
    E.5.2Secondary end point(s)
    To evaluate the safety of fibrinogen infusion in stroke patients with secondary post-rtPA hypofibrinogenemia:
    - Serious thromboembolic adverse events at 7 days after randomization (deep vein thrombosis, pulmonary embolism, myocardial infarct, recurrence of ischemic stroke, MACE defined as all-cause mortality, nonfatal myocardial infarction, andnonfatal stroke)
    To evaluate the efficacy of fibrinogen infusion in stroke patients with secondary post-rtPA hypofibrinogenemia in the clinical outcome defined as:
    - National Institutes of Health Stroke Scale score (NIHSS) at day 7
    - disability at 3 months, assessed with the modified Rankin Scale (mRS). Good outcome is considered as mRS 0-2
    - To evaluate the diagnosis of hyperfibrinolysis detected with Rotation thromboelastometry (ROTEM) in the whole ischemic stroke population randomized in the RCT (200 patients)
    - To correlate hyperfibrinolysis with cerebral bleeding in the whole ischemic stroke population and in each arm
    Valutare la sicurezza dell’infusione di fibrinogeno: frequenza di eventi tromboembolici severi nei 7 giorni successivi alla randomizzazione, inclusivi di trombosi venosa profonda, embolia polmonare, infarto miocardico, ictus ischemico o ricorrenza di ictus ischemico, eventi cardiovascolari maggiori (MACE) definiti come: mortalità da ogni causa, infarto miocardico non-fatale, ictus non-fatale nei primi 7 giorni successivi alla trombolisi
    Valutare l’outcome clinico, definito come: (i) NIHSS a 7 giorni e (ii) disabilità a 90 giorni, definita con la scala modificata di Rankin (modified Rankin scale, mRS), con outcome buono identificato come mRS 0-2.
    Valutare nella popolazione randomizzata la frequenza di iperfibrinolisi identificata con tromboelastogramma (ROTEM)
    Verificare eventuale correlazione tra iperfibrinolisi e ICH nella coorte randomizzata e nei rispettivi bracci di trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    For symptomatic cerebral haemorrhage at 24h and 7 days, as well as extracerebral haemorrhages; Clinical severity measured as NIHSS score at baseline and day 7; disability at 3 months 90 days (90 + 7) will be defined according to the mRS scale, with a good outcome defined as mRS 0-2.
    Per l'emorragia cerebrale sintomatica sempre a 24h e 7 gg, così come emorragie extracerebrali; La gravità clinica misurata come punteggio NIHSSl basale e al giorno 7; la disabilità a 3 mesi 90 giorni (90+7) sarà definita secondo scala mRS, con outcome buono definito come mRS 0-2.
    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 No
    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 Yes
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Nessuna terapia (normale pratica clinica)
    No therapy (Standard of care)
    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 concerned2
    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 No
    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
    Trial duration (months): 36
    Lo studio prevede una durata di 36 mesi
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 No
    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 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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    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)
    Standard of care
    Normale pratica clinica
    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 Decision2021-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-17
    P. End of Trial
    P.End of Trial StatusOngoing
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