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    The EU Clinical Trials Register currently displays   43883   clinical trials with a EudraCT protocol, of which   7296   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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    EudraCT Number:2017-003931-12
    Sponsor's Protocol Code Number:BXU513667
    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:2019-06-20
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-003931-12
    A.3Full title of the trial
    A Randomized Controlled Non-inferiority Study to Evaluate the Efficacy and Safety of Hemopatch Compared to TachoSil in Preventing or Reducing
    Postoperative Air Leaks After Pulmonary Resection
    Studio randomizzato, controllato, di non inferiorità, per valutare l'efficacia e la sicurezza di Hemopatch
    rispetto a TachoSil nella prevenzione o riduzione delle perdite aeree postoperatorie in seguito a resezione polmonare
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of Hemopatch Compared to TachoSil in Preventing or Reducing Postoperative Air Leaks After Pulmonary Resection.
    Studio per valutare l'efficacia e la sicurezza di Hemopatch rispetto a TachoSil nella prevenzione o riduzione delle perdite aeree postoperatorie in seguito a resezione polmonare
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberBXU513667
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    A.5.4Other Identifiers
    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.1.3.4CountryUnited States
    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 supportBaxter Healthcare Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBaxter R&D Europe SPRL
    B.5.2Functional name of contact pointSr Clinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressBoulevard d'Angleterre 2-4
    B.5.3.2Town/ cityBraine l'Alleud
    B.5.3.3Post code1420
    B.5.4Telephone number0032470896582
    B.5.5Fax number0032470896582
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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. name Tachosil sealant matrix
    D. of the Marketing Authorisation holderTAKEDA AUSTRIA GMBH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTachoSil
    D.3.4Pharmaceutical form Sealant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Fibrinogen
    D.3.9.2Current sponsor codeHuman Fibrinogen
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5.5
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Thrombin
    D.3.9.2Current sponsor codeHuman Thrombin
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.0
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) No
    D. 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. medicinal product typeadesivo emostatico
    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
    Postoperative air leakage.
    perdite aeree postoperatorie
    E.1.1.1Medical condition in easily understood language
    Leak of air after surgery pulmonary resection
    perdite di aria dopo intervento chirurgico di resezione polmonare
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10066239
    E.1.2Term Mediastinal shift
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 the efficacy of Hemopatch compared to TachoSil in postoperative air leak duration after pulmonary resection.
    Valutare l’efficacia di Hemopatch rispetto a TachoSil in termini di durata delle perdite aeree postoperatorie in seguito a resezione polmonare.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of Hemopatch compared to TachoSil in postoperative application after pulmonary resection.
    Valutare la sicurezza di Hemopatch rispetto a TachoSil nell’applicazione postoperatoria in seguito a
    resezione polmonare.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Preoperative criteria
    • Patients, 18 years or older at the time of signing the informed consent form (ICF), undergoing elective pulmonary resections (lobectomy,
    segmentectomy, or wedge resection), either through open thoracotomy or through Video-Assisted Thoracoscopic surgery (VATS).
    • Patients or legally authorized representatives, who are able to give IC after an explanation of the proposed study, and who are willing to comply with the study requirements for therapy during the entire study treatment period.
    • If female of child-bearing potential, patient will present with a negative blood/urine pregnancy test, and will agree to employ adequate birth control measures for the duration of the study.
    Intraoperative criteria
    • Patients with grade 1 or 2 (Macchiarini scale) air leakage after primary stapling and limited suturing.
    Criteri preoperatori
    • Pazienti di età pari o superiore a 18 anni al momento della firma del modulo di consenso informato (informed consent form, ICF) sottoposti a intervento di resezione polmonare di elezione [lobectomia, segmentectomia o resezione atipica (“wedge resection”)], mediante toracotomia a cielo aperto o chirurgia toracoscopica video-assistita (Video Assisted Thoracoscopic surgery, VATS).
    • Pazienti o rappresentanti legalmente autorizzati in grado di rilasciare il proprio consenso informato in seguito a spiegazione dello studio proposto e disposti ad attenersi alle richieste dello studio inerenti la terapia durante l’intero periodo di trattamento dello studio.
    • I pazienti di sesso femminile in età fertile dovranno presentare un test di gravidanza sulle urine o sul sangue negativo, e dovranno acconsentire a utilizzare un metodo adeguato di controllo delle nascite per tutta la durata dello studio.

    Criteri Intraoperatori
    • Pazienti con perdite aeree di grado 1 o 2 (scala di Macchiarini) in seguito a suturazione primaria meccanica e minima sutura manuale.
    E.4Principal exclusion criteria
    Preoperative criteria
    • Patients who had previous lung surgery (on the same side)
    • Patients with an active, florid infection
    • Patients who have received chemotherapy within the previous 3 weeks.
    • Patients who have received radiation therapy within the previous 4 weeks.
    • Patients with known hypersensitivity to the components of the investigational product and control (human fibrinogen, human thrombin,
    collagen of any origin, NHS-PEG)
    • Patients undergoing emergency surgery
    • Patients on chronic use of steroids
    • Female patients of childbearing potential with a positive pregnancy test or intent to become pregnant during the clinical study period
    • Female patients who are nursing
    • Patients with exposure to another investigational drug or device clinical trial within 30 days prior to enrollment or anticipated in the 30 day study period till the End of study visit.
    • Patient has a clinically significant concurrent medical condition (e.g. concomitant illness, drug/alcohol abuse) that, in the opinion of the
    investigator, could adversely affect patient's safety and/or compliance with study procedures
    • Patient is a family member or employee of the investigator
    Intraoperative criteria
    • Patients with serious complications during surgery, including the need for adhesiolysis, and pneumonectomy.
    • Patients who were treated with any surgical sealant
    • Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
    • Patients with any other intraoperative findings identified by the surgeon that may preclude the conduct of the study procedure
    Criteri preoperatori
    • Pazienti precedentemente sottoposti a intervento chirurgico polmonare (sullo stesso lato)
    • Pazienti con infezione attiva e florida
    • Pazienti sottoposti a chemioterapia nelle 3 settimane precedenti
    • Pazienti sottoposti a radioterapia nelle 4 settimane precedenti
    • Pazienti con ipersensibilità nota ai componenti del prodotto sperimentale e del controllo (fibrinogeno umano, trombina umana, collagene di qualsiasi origine, NHS-PEG)
    • Pazienti sottoposti a intervento chirurgico di emergenza
    • Pazienti che fanno uso cronico di steroidi
    • Pazienti di sesso femminile in età fertile con test di gravidanza positivo o che stanno programmando una gravidanza per il periodo dello studio clinico
    • Pazienti di sesso femminile in allattamento
    • Pazienti esposti a un altro farmaco o dispositivo sperimentale nell'ambito di uno studio clinico nei 30 giorni precedenti l’arruolamento o nei quali ciò sia previsto nei 30 giorni di durata dello studio, fino alla visita di fine studio
    • Pazienti nei quali coesistano condizioni mediche clinicamente rilevanti (ad es. malattie concomitanti, abuso di stupefacenti/alcolici) che, a giudizio dello sperimentatore, potrebbero influire negativamente sulla sicurezza e/o sull’aderenza del paziente alle procedure dello studio
    • Il paziente è un familiare o dipendente dello sperimentatore
    Criteri intraoperatori
    • Pazienti con complicanze gravi durante l’intervento chirurgico, inclusa la necessità di ricorrere ad adesiolisi e pneumonectomia
    • Pazienti trattati con un sigillante chirurgico di qualsiasi tipo
    • Complicanze intraoperatorie maggiori che richiedano rianimazione o deviazioni rispetto alla procedura chirurgica pianificata
    • Pazienti per i quali in sede intraoperatoria il chirurgo effettui riscontri di altro tipo che potrebbero precludere l’esecuzione della procedura dello studio
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy of Hemopatch compared to TachoSil in postoperative air leak duration after
    pulmonary resection.
    Valutare l’efficacia di Hemopatch rispetto a TachoSil in termini di durata delle perdite aeree
    postoperatorie in seguito a resezione polmonare.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Air leakage will be assessed on the evening of the day of operation and subsequently at least twice daily (morning and evening) until chest drain removal. All patients will be followed up to 30 days postoperatively.
    La valutazione delle perdite aeree postoperatorie verrà eseguita la sera del giorno dell’intervento e successivamente almeno due volte al giorno (mattina e sera) fino alla rimozione del drenaggio toracico. Tutti i pazienti verranno sottoposti a follow-up postoperatorio per un periodo massimo di 30 giorni.
    E.5.2Secondary end point(s)
    Incidence of intraoperative treatment failure
    • Incidence of patients with prolonged air leakage defined as air leakage > 5 days
    • Evaluation of hemostasis after application of product if bleeding at the surgical site occurs
    • The need for additional procedures (chest drainage, re-operation, respiratory assistance, and blood
    • Time to chest tube removal
    • Time in surgery (minutes) from incision to closure
    • Length of stay in hospital (days)
    • Number of unplanned interventions within 30 days postoperatively
    • Incidence of adverse events (AEs) including pre-defined postoperative Adverse Events of Special
    Interest (AESIs) up to 30 ± 3 days after surgery:
    - Pneumothorax
    - Bronchopleural fistula
    - Emphysema (subcutaneous and mediastinal)
    - Pleural effusions
    - Postoperative respiratory failure
    - Empyema
    - Allergic reactions in reasonable temporal relationship with the product application
    • Number of patches used (for both investigational and control devices)
    • Vital signs and laboratory tests
    • Incidenza del fallimento terapeutico intraoperatorio
    • Incidenza di pazienti con perdita aerea prolungata, definita come perdita aerea di durata > 5 giorni
    • Valutazione dell’emostasi dopo l’applicazione del prodotto se si verifica un’emorragia nella sede chirurgica
    • Necessità di procedure supplementari (drenaggio toracico, reintervento, assistenza respiratoria e trasfusione ematica)
    • Tempo alla rimozione del tubo di drenaggio toracico
    • Durata dell’intervento (minuti) dall’incisione alla chiusura
    • Durata della degenza ospedaliera (giorni)
    • Numero di interventi non pianificati entro 30 giorni dall'intervento
    • Incidenza di eventi avversi (Adverse Events, AE), inclusi eventi avversi di particolare interesse (Adverse Events of Special Interest, AESI) postoperatori predefiniti, fino a 30 ± 3 giorni dopo l’intervento:
    - Pneumotorace
    - Fistola broncopleurica
    - Enfisema (sottocutaneo e del mediastino)
    - Versamenti pleurici
    - Insufficienza respiratoria postoperatoria
    - Empiema
    - Reazioni allergiche per le quali sussista una relazione temporale ragionevole con l’applicazione del prodotto
    • Numero di patch utilizzati (sia per il dispositivo sperimentale sia per il dispositivo di controllo)
    • Segni vitali ed esami di laboratorio
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoint will be assessed during surgery.
    gli endpoint secondary saranno valutati durante operazione
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 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) 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    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 months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 111
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 Yes
    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 state67
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 166
    F.4.2.2In the whole clinical trial 166
    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
    Standard of Care
    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 Decision2018-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-24
    P. End of Trial
    P.End of Trial StatusCompleted
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