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    Summary
    EudraCT Number:2009-013056-71
    Sponsor's Protocol Code Number:TC-2402-038-SP
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-28
    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 ConcernedBelgium - FPS Health-DGM
    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, multicentre, parallel group efficacy and safety trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this trial is to scientifically assess the performance and safety of TachoSil when used as a seal to prevent the leaking of brain fluid in patients who have undergone skull based surgery. TachoSil will be compared to the current practice already used within the hospital

    A.3.2Name or abbreviated title of the trial where available
    TASALL -TachoSil Against Liquor Leak
    A.4.1Sponsor's protocol code numberTC-2402-038-SP
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00999999
    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 SponsorTakeda Pharma A/S
    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 supportTakeda Pharma A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTakeda Pharma A/S
    B.5.2Functional name of contact pointClinical Trial Operations
    B.5.3 Address:
    B.5.3.1Street AddressLangebjerg 1
    B.5.3.2Town/ cityRoskilde
    B.5.3.3Post code4000
    B.5.3.4CountryDenmark
    B.5.4Telephone number+454677 1111
    B.5.5Fax number+454675 4269
    B.5.6E-mailCamilla.Walker@takeda.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 TachoSil medicated sponge
    D.2.1.1.2Name of the Marketing Authorisation holderNycomed 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 Medicated sponge
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPLocal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Thrombin
    D.3.9.1CAS number 0
    D.3.9.3Other descriptive nameTHROMBIN, HUMAN
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Fibrinogen
    D.3.9.1CAS number 9001-32-5
    D.3.9.3Other descriptive nameHUMAN 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.3.11 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 medicated sponge
    D.2.1.1.2Name of the Marketing Authorisation holderNycomed 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 Medicated sponge
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPLocal use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHUMAN THROMBIN
    D.3.9.1CAS number 0
    D.3.9.3Other descriptive nameTHROMBIN, HUMAN
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHuman Fibrinogen
    D.3.9.1CAS number 9001-32-5
    D.3.9.3Other descriptive nameHUMAN 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.3.11 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
    E.1.1.1Medical condition in easily understood language
    Patients undergoing skull based surgery
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10067908
    E.1.2Term Neurosurgery
    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.
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pre-operative Inclusion Criteria – positive response required for inclusion:
    1. Has written informed consent been obtained before any trial-related activities? (A trial-related activity is any procedure that would not have been performed during the routine management of the patient)
    2. Is the patient considered able and willing to comply with the procedures required for trial completion?
    3. Is the patient 18 years or above?
    4. Is the patient to undergo non-trauma related neurosurgery for pathology of the skull base resulting in opening and closing of the dura mater? Dura substitution is allowed.
    5. Has a CT or MRI scan of the head been performed within 4 month before screening?

    Intra-operative Inclusion Criteria – positive response required for inclusion:
    6. Is the Surgical Wound Classification Class of class I (Clean surgical wound)? (Clean wound definition: Uninfected surgical wounds in which no inflammation is encountered and the respiratory, alimentary, genital, or uninfected urinary tracts are not entered. In addition, clean wounds are primarily closed, and if necessary, drained with closed drainage)
    7. Is the surgical approach/procedure consistent with skull base surgery? I.e. at least 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
    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.
    E.4Principal exclusion criteria
    Pre-operative Exclusion Criteria – negative response required for inclusion:
    1. Has the patient been randomised in another clinical trial with an investigational medicinal product or device within 28 days before screening for this trial? (Participation in non-interventional studies is allowed)
    2. Has the patient previously participated in this trial?
    3. Does the patient have evidence of an infection within 5 days of surgery indicated by any one of the following:
    Fever >101°F / 38.5°C, white blood cells (WBC) <3.5/GL or >13.0/GL (if patient on steroid treatment > 20.00/GL), positive urine culture, positive blood culture, positive chest Xray?
    4. Does the patient have a known coagulopathy?
    5. Does the patient have a history of allergic reactions after application of human
    fibrinogen, human thrombin and / or collagen of any origin?
    6. Has the patient been subject to neurosurgery involving opening of the dura matter within the last 3 months before Screening for this trial?
    7. Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura matter which may affect the efficacy evaluation (e.g. re-operation or anticipation to undergo several neurosurgeries) before the Efficacy Follow-up 7±1 week?
    8. Is the patient anticipated to undergo any additional neurosurgery involving opening of the dura matter 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?

    For females of childbearing potential, i.e. neither postmenopausal (less than 12 months after the last menstruation) nor permanently sterilised (e.g. tubal occlusion, hysterectomy, bilateral salpingectomy):
    9. Does the female patient use an unacceptable contraceptive method or method
    ineffective at the time of randomisation, i.e. do not use a contraceptive method which is a highly effective method of birth control; defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices, vasectomised partner or double barrier contraception?
    10. Has the contraceptive method been used too short to be effective?
    11. Has the female patient had a positive serum pregnancy test taken within 5 days prior to surgery? All females not documented as postmenopausal or permanently sterile must have a serum pregnancy test performed.
    12. Breastfeeding?

    Intra-operative Exclusion Criteria – negative response required for inclusion:
    13. The surgical approach/procedure is consistent with any transcranial or transfacial or combination of transcranial – transfacial approaches with wide defect in the skull base? any of the following:
    a. Trans basal approach,
    b. Total petrosectomy,
    c. Trans facial approach,
    d. Trans sphenoidal approach,
    e. Endoscopic procedures,
    f. Trans oral approach (and any extension: Le Fort, mandibulotomy).
    14. The surgical approach is consistent with one of the following approaches?
    a. Translabyrinthine approach
    b. Retrolabyrinthine approach
    c. Transcochlear (limited transpetrosal) approach
    15. Did the arachnoid membrane and the CS containing system remain intact during surgery?
    16. Does the patient have more than one dura opening (not including dura openings from extraventricular or lumbar drains)?
    17. Has TachoSil, fibrin or polymer sealants been used during the current surgery prior to randomisation?
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    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.
    E.5.2Secondary end point(s)
    The secondary endpoint must be considered as reached if a non-clinically evident pseudomeningocele has occurred post-operatively and until Day of Discharge without achieving the primary endpoint.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoint must be considered as reached if a non-clinically evident pseudomeningocele has occurred post-operatively and until Day of Discharge without achieving the primary endpoint.
    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
    Standard treatment for closure of the dura or duraplasty
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Austria
    Belgium
    France
    Germany
    Greece
    Italy
    Netherlands
    Poland
    Russian Federation
    Spain
    Sweden
    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
    The end-of-trial is defined as last patient last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 550
    F.4.2.2In the whole clinical trial 726
    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)
    After participation in the trial, if applicable, patients will be treated with the current standard therapy.

    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 Decision2009-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-27
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