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    Summary
    EudraCT Number:2011-005749-10
    Sponsor's Protocol Code Number:NL38212
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-06-05
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-005749-10
    A.3Full title of the trial
    Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses.

    A non-randomized single center study.
    Veiligheid en Haalbaarheid van TachoSil®: Toepassing op Oesofageale Anastomosen.

    Een niet-gerandomiseerde monocenter studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Safety and Feasibility of TachoSil® application on connections of the esophagus.
    De veiligheid en haalbaarheid van TachoSil® aangebracht op de slokdarm naad.
    A.3.2Name or abbreviated title of the trial where available
    SAFE-T
    A.4.1Sponsor's protocol code numberNL38212
    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 SponsorUniversity Medical Center Utrecht
    B.1.3.4CountryNetherlands
    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 supportUMC Utrecht
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUMC Utrecht
    B.5.2Functional name of contact pointLeonie Haverkamp
    B.5.3 Address:
    B.5.3.1Street AddressHeidelberglaan 100
    B.5.3.2Town/ cityUtrecht
    B.5.3.3Post code3584CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31887558507
    B.5.5Fax number+31302541944
    B.5.6E-mailL.Haverkamp@umcutrecht.nl
    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 medicated sponge
    D.3.4Pharmaceutical form Absorbable coated sponge
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTopical use (Noncurrent)
    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.3.9.4EV Substance CodeSUB12502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3.6 to 7.4
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNhuman thrombin
    D.3.9.1CAS number 04/04/9002
    D.3.9.3Other descriptive nameHUMAN THROMBIN
    D.3.9.4EV Substance CodeSUB20551
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.3 to 2.7
    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
    Anastomotic leakage
    Lekkage van anastomose
    E.1.1.1Medical condition in easily understood language
    Conjunction leakage
    Naadlekkage
    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 LLT
    E.1.2Classification code 10065961
    E.1.2Term Esophageal anastomotic leak
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10065890
    E.1.2Term Oesophageal anastomotic leak
    E.1.2System Organ Class 10022117 - Injury, poisoning and procedural complications
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluation of the feasibility of Tachosil application on esophageal anastomoses.
    Evaluatie van de haalbaarheid van het aanbrengen van tachosil op oesofageale anastomosen.
    E.2.2Secondary objectives of the trial
    Evaluation of the safety of Tachosil application on esophageal anastomoses.
    Evaluatie van de veiligheid van het aanbrengen van tachosil op oesofageale anastomosen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients undergoing an elective total gastrectomy with an esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis
    • Ages 18-80
    • Signed informed consent
    • Patienten die een electieve totale maagresectie met oesofago-jejunostomie of oesofagus resectie met oesofago-gastrostomie ondergaan.
    • Leeftijd 18-80
    • Ondertekende toestemmingverklaring
    E.4Principal exclusion criteria
    • Emergency resections of esophagus of stomach
    • History of hypersensitivity reactions to human fibrinogen, human thrombin, or collagen.
    • Patients having difficulty understanding the Dutch and English language
    • Mentally incapable patients
    • Pregnancy or breast feeding
    • Spoed resecties van oesofagus of maag
    • Voorgeschiedenis van hypersensitiviteit reacties op humaan fibrinogeen, humaan thrombine of collageen.
    • Patienten die geen Nederlands of Engels verstaan
    • Wilsonbekwame personen
    • Zwangerschap of borstvoeding
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter is the feasibility of TachoSil® application on esophageal anastomoses, which is assessed by 2 investigators who will evaluate video recordings. Feasibility is measured by the adherence and location of the TachoSil® patch, defined according to the following criteria:
    • Adherence of complete TachoSil® patch
    • TachoSil® covers at least 1 cm beyond the margins of anastomotic line
    • Overlap of at least 1 cm if multiple patches are used
    De primaire uitkomst maat is het onderzoeken van de haalbaarheid van het aanbrengen van tachosil op oesofageale anastomosen. Dit zal onderzocht worden door 2 onderzoekers aan de hand van video opnames. De haalbaarheid wordt geobjectiveerd door de mate van het vasthechten van tachosil en de locatie van tachosil, gedefineerd als:
    • Vasthechten van complete tachosil patch
    • Tachosil bedekt minimaal 1 cm voorbij de anastomose
    • Patches overlappen minimaal 1cm, indien meerdere patches worden gebruikt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Duration of construction of the anastomosis, during surgery.
    Duur van het aanleggen van de anastomose, tijdens de operatie.
    E.5.2Secondary end point(s)
    Safety
    • Mortality
    - 30-day (n)
    - 60-day (n)
    - in hospital (n)
    • Serious adverse events (n)
    • Adverse events (n)
    • Anastomotic leakage (n)
    • Location of anastomotic leakage
    - Cervical (n)
    - Intrathoracic (n)
    • Anastomotic stricture (n)
    • Post-operative complications (n): Respiratory complications (pneumonia, ARDS, respiratory insufficiency), cardiac complications (ischemic and arrhythmic), lymphorrhea, vocal-cord paralysis, sepsis, urinary tract infection, wound infection, fistula, mediastinitis, thorax empyema.
    • Postoperative course:
    - Duration of Intensive Care stay (days)
    - Duration of Medium Care stay (days)
    - Total duration of hospital stay (days)
    - Mechanical ventilation (days)
    Veiligheid
    • Mortaliteit
    - 30-dagen (n)
    - 60-dagen (n)
    - in ziekenhuis (n)
    • Serious adverse events (n)
    • Adverse events (n)
    • Naadlekkage (n)
    • Locatie naadlekkage
    - Cervicaal (n)
    - Intrathoracaal (n)
    • Stenose ter plaatse van anastomose (n)
    • Postoperatieve complicaties (n): Respiratoire complicaties (pneumonie, ARDS, respiratoire insufficientie), cardiale complicaties (ischemie and arrhythmie), chylus lekkage, stemband paralyse, sepsis, urine weg infectie, wond infectie, fistel, mediastinitis, thorax empyeem.
    • Postoperatief beloop:
    - Duur Intensive Care opname (dagen)
    - Duur Medium Care opname (dagen)
    - Total duration of hospital opname (dagen)
    - Mechanische ventilatie (dagen)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day of Surgery (day 0)
    Day of discharge from surgical ward
    3 months after surgery
    9 months after surgery

    Dag van operatie (dag 0)
    Dag van ontslag van afdeling heelkunde
    3 maanden na operatie
    9 maanden na operatie
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    The planned end-of-trial is defined as the last visit of the last participant. The last visit takes place 9 months after initial surgery. According to our UMCU database >95% of the patients with anastomotic stenosis will present at the outpatient visit with symptoms within 9 months.

    Het geplande einde-van-trial is gedefineerd als het laatste bezoek van de laatste deelnemer. Het laatste bezoek vindt plaats 9 maanden na initiele operatie. Volgens onze UMCU database zullen zich binnen 9 maanden >95% van de patienten met een stenose ter plaatse van de anastomose gemeld hebben op de polikliniek.
    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 months9
    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 months9
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state15
    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)
    Regular treatment
    Standaard behandeling
    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 Decision2012-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-01
    P. End of Trial
    P.End of Trial StatusOngoing
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