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    Summary
    EudraCT Number:2011-006059-13
    Sponsor's Protocol Code Number:Tacho01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-06-18
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-006059-13
    A.3Full title of the trial
    The use of Tachosil as sealant in the prevention of lymphorrea after groin lymphadenectomy for vulvar cancer: a clinical controlled prospective trial
    Studio clinico controllato prospettico sull'utilizzo di Tachosil a scopo sigillante nella linfoadenectomia inguino-femorale del carcinoma vulvare
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The use of Tachosil as sealant in the prevention of lymphorrea after surgical removal of lymph nodes for vulvar cancer: a clinical controlled prospective trial
    Studio clinico prospettico con controlli sull'utilizzo di Tachosil a scopo sigillante nell'asportazione inguino-femorale di linfonodi del tumore della vulva
    A.3.2Name or abbreviated title of the trial where available
    Tacho01
    Tacho01
    A.4.1Sponsor's protocol code numberTacho01
    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 SponsorA.O. UNIVERSITARIA INTEGRATA DI VERONA
    B.1.3.4CountryItaly
    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 supportFondi di reparto U.O Ostetricia e Ginecologia
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationA.O. UNIVERSITARIA INTEGRATA DI VERONA
    B.5.2Functional name of contact pointU.O. Ostetricia e Ginecologia
    B.5.3 Address:
    B.5.3.1Street AddressP.le LA Scuro, 10
    B.5.3.2Town/ cityVerona
    B.5.3.3Post code37124
    B.5.3.4CountryItaly
    B.5.4Telephone number045 8124407
    B.5.5Fax number045 8027481
    B.5.6E-mailanna.festi@ospedaleuniverona.it
    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*1SPUGNA 9,5CMx4,8CM
    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 Medicated sponge
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOther 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.3.9.4EV Substance CodeSUB12502MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250.8
    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.3.9.4EV Substance CodeSUB20551
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number91.2
    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 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.3.11.13.1Other medicinal product typeemoderivato
    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
    lymphedema after groin lymphadenectomy in patients with vulvar cancer
    linfedema degli arti inferiori post linfoadenectomia inguino-femorale per pazienti affette da carcinoma vulvare
    E.1.1.1Medical condition in easily understood language
    lymph accumulation after groin lymphadenectomy in patients with vulvar cancer
    accumulo di linfa negli arti inferiori post intervento in pazienti affette da carcinoma vulvare
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10025233
    E.1.2Term Lymphedema
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    reduction of grade 2 and grade 3 lymphedema incidence 3 months after the surgery in patients treated with TachoSil after groin Lymphadenectomy for vulvar cancer
    valutare la riduzione dell’incidenza di linfedema di grado 2 e 3 a mesi 3 dall’intervento chirurgico nelle pazienti trattate con TachoSil in corso di vulvectomia e linfoadenectomia inguino-femorale per carcinoma vulvare.
    E.2.2Secondary objectives of the trial
    reduction of other lymph node dissection complications (noticed at the discharge, at 3 months and 6 months) such as lymphorrea, wound dehiscence, infections, haematomas, symptomatic or asymptomatic lymphoceles, hospital discharge lymphedema and lymphedema 6 months after the surgery
    valutare l’effetto del sigillante TachoSil sulle altre complicanze della linfoadenectomia inguinale,quali linforrea,deiscenza di ferita,cellulite,ematomi,linfocisti o linfoceli (sintomatici o asintomatici),linfedema alla dimissione,a 6 settimane o a mesi 6 dall’intervento.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with histological diagnosis of vulvar cancer; - Stromal invasion > 1mm at the biopsy; - Performance status 0,1,2 o 3; - Platelets > 100000/mmc; - Creatinine <2 mg/dl; - Bilirubin <1.5 x normal value; - AST e ALT < 3 x normal value.
    - Pazienti con diagnosi istologica di carcinoma vulvare di qualsiasi istotipo. - Presenza di invasione stromale &gt;1mm all’esame bioptico/ escissionale. - Performance status 0,1,2 o 3; - Piastrine &gt; 100000/mmc; - Creatinina &lt;2 mg/dl; - Bilirubina &lt;1.5 x valore normale; - AST e ALT &lt; 3 x valore normale; - Età &gt; 50 anni.
    E.4Principal exclusion criteria
    - Previous Radio-Chemotherapy; - Pre-existing primary and secondary lower extremity lymphedema; - Superficial phlebitis or ulcer or lower extremity chronic infection; - Sealant excipients hypersensitivity.
    - Precedente trattamento chemio/ radioterapico; - Linfedema primario o secondario degli arti inferiori pre-esistente; - Flebite superficiale o ulcera o infezione cronica arti inferiori; - Ipersensibilità agli eccipienti del sigillante
    E.5 End points
    E.5.1Primary end point(s)
    proportion of patients with grade 2 and grade 3 lymphedema at the discharge, at 6 weeks and 6 months after the surgery
    proporzione di pazienti che riportano linfedema di grado 2 o 3 a mesi 3 dall'intervento
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months after surgery
    3 mesi dall'intervento
    E.5.2Secondary end point(s)
    Effectiveness Parameters: 1. proportion of patients with grade 2 and grade 3 lymphedema at the discharge, at 6 weeks and 6 months after the surgery; 2.developing of symptomatic or asymptomatic lymphoceles; 3. if lymphoceles drainage, quantity of dained fluid; 4. number of days with drains (the removal of drains is forecast when the drained liquid is < 50cc); 4.volume of drained fluid each day 5. developing of other complications related to lymph node dissection such as infections, haematomas and wound dehiscence. SAFETY EVALUATION:1.angiooedeme, burning and pain in the drug application point (inguinal careful inspection during the hospitalization and during the follow-up medical examinations);2. increase of body temperature (measured during all the hospitalization period, 3 times a day); 4. bronchospasm, shivers, burst of heat, headache, hypotension, lethargy, feeling sick, tachycardia, feeling of thoracic constriction, tingling, vomiting (evaluation of all these parameters in the period after the surgery to detect possible hyper sensibility reactions).
    VALUTAZIONE EFFICACIA:1. proporzione di pazienti che riportano linfedema di grado 2 o 3 alla dimissione e a mesi 6 dall'intervento; 2. sviluppo di linfoceli sintomatici e asintomatici; 3. se drenaggio dei linfoceli: quantità di liquido drenato; 4. durata di mantenimento del drenaggio (assumendo che venga tolto quando il liquido drenato sia < a 50cc); 5. volume di liquido fuoriuscito dai drenaggi; 6. sviluppo di complicanze post-operatorie quali ematomi, cellulite, deiscenza ferite. VALUTAZIONE SICUREZZA: 1.- angioedema, bruciore o dolore in corrispondenza del sito di applicazione del farmaco (ispezione accurata della zona inguinale durante tutti i giorni della degenza e nelle visite di follow up); 2. rialzo della temperatura corporea (misurazione durante tutto il periodo di degenza, 3 volte al giorno); 3.broncospasmo, brividi, vampate, orticaria generalizzata, cefalea, ipotensione, letargia, nausea, irrequietezza, tachicardia, senso di costrizione toracica, formicolio, vomito, sibili (valutazione nel post-operatorio per individuare possibili reazioni di ipersensibilità)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the discharge, at 6 weeks and 6 months after the surgery: proportion of patients with grade 2/3 lymphedema; during the hospitalization, at 6 weeks, at 3 and 6 months after the surgery: developing of symptomatic or asymptomatic lymphoceles; if lymphoceles drainage, quantity of dained fluid, developing of other complications related to lymphnode dissection. During the hospitalization: number of days with drains, volume of drained fluid each day. SAFETY EVALUATION:angiooedeme, burning and pain in the drug application point: during the hospitalization and during the follow-up medical examinations; increase of body temperature: during all the hospitalization period, 3 times/day); evaluation of all complications in the period after the surgery to detect hypersensibility reactions
    Alla dimissione e a mesi 6 dall'intervento: proporzione di pazienti che riportano linfedema di grado 2/3; Durante il ricovero, a 6 settimane, a 3 mesi ed a 6 mesi dall'intervento: sviluppo di linfoceli sintomatici e asintomatici, quantità di liquido drenato se drenaggio dei linfoceli, sviluppo di complicanze post-operatorie. Durante il ricovero: durata di mantenimento del drenaggio e volume di liquido fuoriuscito dai drenaggi. VALUTAZIONE SICUREZZA:angioedema, bruciore o dolore in corrispondenza del sito di applicazione del farmaco: durante tutti i giorni della degenza e nelle visite di follow up; rialzo della temperatura corporea: durante tutto il periodo di degenza, 3 volte Dì;valutazione nel post-operatorio per individuare possibili reazioni di ipersensibilità
    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 No
    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) 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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    intrasoggetto
    inter patient
    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
    nessun trattamento
    no treatment
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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.1.2.1Number of subjects for this age range: 10
    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 No
    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 state25
    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)
    ND
    ND
    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 Decision2012-04-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-04
    P. End of Trial
    P.End of Trial StatusOngoing
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