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    Summary
    EudraCT Number:2009-016501-41
    Sponsor's Protocol Code Number:400-09-001
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-12-30
    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 ConcernedGermany - PEI
    A.2EudraCT number2009-016501-41
    A.3Full title of the trial
    A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Evicel as an Adjunct to Sutured Dural Repair
    A.4.1Sponsor's protocol code number400-09-001
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorOmrix Biopharmaceuticals Ltd
    B.1.3.4CountryIsrael
    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 Evicel
    D.2.1.1.2Name of the Marketing Authorisation holderOmrix Biopharmaceuticals
    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.3.4Pharmaceutical form Sealant
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 Thrombin
    D.3.9.1CAS number 9002-04-4
    D.3.9.3Other descriptive nameThrombin
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number800 to 1200
    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 nameBAC2
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number50 to 90
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    tissue adhesion/sealing and suture support in neurosurgery and surgical procedures where contact with cerebrospinal fluid or dura mater can occur e.g. otologic, rhinologic, ophthalmic and vertebral surgery.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to evaluate the safety and efficacy of Evicel for use as an adjunct to dura sutures in elective cranial surgery to provide watertight closure.
    E.2.2Secondary objectives of the trial
    - Incidence of CSF leakage as detected by clinical observation or as observed on T2 Gradient Echo MRI by Day 5 post-operatively.
    - Incidence of CSF leakage as detected by clinical observation or as observed on T2 Gradient Echo MRI approximately 30 days (+/-3) post operatively.
    - Incidence of adverse events
    - Dural sealing related adverse events (i.e. CSF leaks, pseudomeningocele formation, etc.)
    - Incidence of surgical site infections (SSI) according to National Nosocomial Infection Surveillance (NNIS) criteria approximately 30 days (+/- 3) post-operatively.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Preoperative
    • Patient undergoing elective craniotomy/craniectomy for pathological processes in the posterior fossa (such as benign and malignant tumors, vascular malformation, and Chiari 1 malformations) or in the supratentorial region and who are demonstrated to have persistent CSF leakage following suture closure of the dural incision. CSF leakage will be evaluated during a period of Valsalva of 20 cm of H20 for 5-10 seconds.
    • Age  3 years
    • Patients who are able and willing to comply with the procedures required by the protocol.
    • Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-related procedures.

    Intraoperative
    • Surgical wound classification Class I. Penetration of mastoid air cells during partial mastoidectomy is permitted.
    • The cuff of native dura along the craniotomy edge is  10 mm wide, to facilitate suturing and to allow for sufficient surface area for adherence of the investigational product.
    E.4Principal exclusion criteria
    Preoperative:
    • Subjects with a dura lesion from a recent surgery that still has the potential for CSF leakage.
    • Chemotherapy scheduled within 7 days following surgery.
    • Radiation therapy to the head scheduled within 7 days following surgery.
    • Long-term low dose steroid therapy to be resumed within 7 days following surgery. However, postoperative tapered high-dose steroids are permitted.
    • Subjects with severely altered renal (serum creatinine > 2 mg/dL) and/or hepatic function ALT, AST > 5 x upper limit of norm (ULN)
    • Evidence of an infection indicated by any one of the following: fever > 38C, WBC < 3500/uL or > 13000/uL, positive urine culture, positive blood culture, positive chest X-ray, evidence of infection along the planned surgical path. A WBC count of <20000 is permitted if the patient is being treated with steroids in the absence of all the other infection parameters.
    • Conditions compromising the immune system; existence of autoimmune disease.
    • Known hypersensitivity to the components (human fibrinogen, arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, human thrombin, human albumin, mannitol and sodium acetate) of the investigational product.
    • Non-compliant or insufficient treatment of diabetes mellitus glycosylated hemoglobin (HbA1c) > 7.5%.
    • Hydrocephalus, except occlusive hydrocephalus caused by posterior fossa pathology to be treated.
    • Existing CSF (ventricular, etc.) drains. Burr holes are permitted as long as the dura remains intact. Cushing cannulation excludes the subject.
    • Female subjects of childbearing potential with a positive urine or serum pregnancy test within 24 hours prior to surgery.
    • Female subjects who are breastfeeding, pregnant, or intend to become pregnant during the clinical study period.
    • Participation in another clinical trial with exposure to another investigational drug or device within 30 days prior to enrollment.
    • Scheduled or foreseeable surgery within the follow-up period.

    Intraoperative:

    • Dura injury during craniotomy/craniectomy that cannot be eliminated by widening the craniotomy/craniectomy to recreate the native dura cuff.
    • Failure to administer preoperative antibiotic prophylaxis
    • Use of implants made of synthetic materials coming into direct contact with dura (e.g., PTFE patches, shunts, ventricular and subdural drains).
    • Placement of Gliadel Wafers
    • Chiari 1 subjects without injury to the arachnoid.
    • Persistent signs of increased brain turgor
    • Patient has a gap of greater than 2mm after primary dural closure.
    • Intersecting durotomy scars in the surgical path from a previous operation that cannot be completely removed by the planned dura resection.
    • Two or more separate dura defects
    • Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of success (watertight closure) in the treatment of intra-operative CSF leakage defined as no CSF leakage from dural repair intra-operatively, during Valsalva maneuver up to 20 cm H2O for 5 to 10 seconds
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    additional dural sutures as deemed necessary by the surgeon
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    last visit of the last subject
    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 months0
    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 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 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 130
    F.4.2.2In the whole clinical trial 130
    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)
    The following information will be recorded at the follow-up visit approximately 30 days following surgery: Physical examination, Neurological examination, Laboratory tests, Surgical site infection evaluation, Wound healing assessment, Changes in concomitant medications, Adverse events.
    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 Decision2010-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-29
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-10-25
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