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    Summary
    EudraCT Number:2009-013056-71
    Sponsor's Protocol Code Number:TC-2402-038-SP
    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:2012-04-13
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2009-013056-71
    A.3Full title of the trial
    TachoSil versus current practice in dura sealing techniques for the prevention of post-operative cerebrospinal fluid (CSF) leaks in patients undergoing skull base surgery: An open label, randomised, controlled, multi-centre, parallel group efficacy and safety trial.
    Confronto tra TachoSil e le correnti tecniche utilizzate di sutura della dura madre per la prevenzione delle perdite postoperatorie di liquido cerebrospinale (LCS) in pazienti sottoposti a chirurgia della base del cranio: studio in aperto, randomizzato, controllato, multicentrico, a gruppi paralleli sull`efficacia e la sicurezza
    A.3.2Name or abbreviated title of the trial where available
    TASALL -TachoSil Against Liquor Leak
    TASALL
    A.4.1Sponsor's protocol code numberTC-2402-038-SP
    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 SponsorNycomed Danmark ApS
    B.1.3.4CountryDenmark
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 TACHOSIL
    D.2.1.1.2Name of the Marketing Authorisation holderNYCOMED ITALIA Srl
    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.3.4Pharmaceutical form Impregnated dressing
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCombinations
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    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 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 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.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 TACHOSIL
    D.2.1.1.2Name of the Marketing Authorisation holderNYCOMED ITALIA Srl
    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.3.4Pharmaceutical form Impregnated dressing
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCombinations
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number5.5
    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 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 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
    Skull base surgery for the prevention of postoperative cerebrospinal fluid (CSF) leaks
    Sutura della dura madre per la prevenzione delle perdite postoperatorie di liquido cerebrospinale (LCS) in pazienti sottoposti a chirurgia della base del cranio
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10064518
    E.1.2Term Cranial operation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 demonstrate superiority of TachoSil compared to current practice as an adjunct in sealing the dura mater. The efficacy of the dura mater sealing must be evaluated postoperatively.
    L’obiettivo primario e di dimostare la superiorita` di TachoSil in confronto alle tecniche correntemente utilizzate nella sutura della dura madre. L’efficacia della sutura della dura madre sara` valutata nel post operatorio.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the safety of TachoSil as an adjunct in sealing the dura mater.
    L’obiettivo secondario e` quello di valutare la sicurezza di TachoSil come coadiuvante della sutura della dura madre.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key inclusion criteria – positive response required for inclusion: • Is the surgical approach/procedure consistent with skull base surgery? I.e. one of the following: a. Lateral approach to the foramen magnum: Far lateral, extreme lateral, anterolateral, posterolateral b. Approach to the jugular foramen: Infratemporal, juxta condylar, transjugular c. Approach to the cerebello pontine (CP) angle and petrous apex retrosigmoid, translabyrinthine, retrolabyrinthine, transcochlear (limited transpetrosal) d. Approach to the middle fossa: Subtemporal (+/- petrous apex drilling), pterional approach (any fronto temporal approach +/- orbitozygomatic deposition) e. Approach to the anterior fossa: Subfrontal (uni or bilateral) f. Approach to the midline posterior fossa For a complete list of inclusion criteria, please refer to the study protocol.
    Principali criteri di inclusione – e` richiesta una risposta positiva: • L’approccio chirurgico/la procedura chirurgica e` compatibile con la chirurgia della base del cranio? Ad esempio uno dei seguenti: a. Approccio laterale al grande foro occipitale: molto laterale, estremamente laterale, anterolaterale, posterolaterale, b. Approccio al forame giugulare: infratemporale, iuxta condiloideo, transgiugulare, c. Approccio all’angolo ponto-cerebellare (CP) e all’apice petroso per via retrosigmoidea, translabirintica, retrolabirintica, transcocleare (transpetrosa limitata), d. Approccio alla fossa media: subtemporale (+/- trapanatura dell`apice petroso), approccio pterionale (qualsiasi approccio fronto-temporale +/- deposito orbito-zigomatico), e. Approccio alla fossa anteriore: subfrontale (monolaterale o bilaterale), f. Approccio alla fossa posteriore nella linea mediana. Per una lista completa dei criteri di inclusione, fare riferimento al protocollo di studio.
    E.4Principal exclusion criteria
    Key exclusion criteria – negative response required for inclusion: • Has the patient been subject to neurosurgery within the last 3 months? • Is the patient anticipated to undergo any additional neurosurgery which may affect the efficacy evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Efficacy Follow-up Week 7±1 week? • Is the patient anticipated to undergo any additional neurosurgery which may affect the safety evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Safety Follow-up Week 28±2 weeks? • The surgical approach/procedure is consistent with any transcranial or transfacial or combination of transcranial – transfacial approaches with wide defect in the skull base? I.e. any of the following: g. Trans basal approach h. Total petrosectomy i. Trans facial approach j. Trans sphenoidal approach k. Endoscopic procedures l. Trans oral approach (and any extension: Le Fort, mandibulotomy) • Does the patient have more than one dura lesion (not including dura lesions from extraventricular or lumbar drains)? For a complete list of exclusion criteria, please refer to the study protocol.
    Principali criteri d’esclusione – e` richiesta una risposta negativa: • Il paziente e` stato sottoposto a neurochirurgia negli ultimi 3 mesi? • E` previsto che il paziente sia sottoposto a qualsisi ulteriore neurochirurgia che possa avere effetto sulla valutazione di efficacia (ad esempio re-intervento o in attesa di sottoporsi a piu` interventi di neurochirurgia) prima del follow-up sulla sicurezza (Settimana 28 ± 2 settimane)? • L’approccio chirurgico/la procedura chirurgica e` compatibile con qualsiasi approccio transcraniale o transfacciale o la combinazione di approccio transcraniale \ transfacciale con ampio difetto dalla chirurgia della base del cranio? Ad esempio uno o piu` dei seguenti: g. Approccio transbasale, h. Petrosectomia totale, i. Approccio transfacciale, j. Approccio transfenoidale, k. Procedure endoscopiche, l. Approccio transorale (e qualsiasi estensione: Le Fort, mandibulotomia). • Il paziente ha piu` di una lesione della dura (escluso lesioni della dura da drenaggio extraventricolare o lombare)? Per una lista completa dei criteri di esclusione, fare riferimento al protocollo di studio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint must be considered as reached if a clinically evident CSF- leak or a clinically evident pseudomeningocele has occurred post-operatively and until Efficacy Follow-up (week 7±1) or if treatment failure has occurred.
    L’endpoint primario deve essere considerato raggiunto se si e` verificata un’evidenza clinica di perdita di liquido cerebrospinale (LCS) o un’evidenza clinica di pseudomeningocele nel postoperatorio fino alla Visita di follow-up di efficacia (settimana 7±1) o se si e` verificato il fallimento della terapia
    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
    correnti tecniche utilizzate x sutura dura madre
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Ultima visita dell'ultimo paziente
    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 months22
    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 months22
    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: 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.1.3Elderly (>=65 years) Yes
    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 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 state57
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 550
    F.4.2.2In the whole clinical trial 726
    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 Decision2011-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-09-06
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