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    Summary
    EudraCT Number:2009-013618-29
    Sponsor's Protocol Code Number:1160.89
    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:2012-03-30
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2009-013618-29
    A.3Full title of the trial
    Open-label safety and tolerability of dabigatran etexilate mesilate given for 3 days at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years, and 1 year to less than 2 years
    Studio in aperto per valutare la sicurezza e la tollerabilita' di dabigatran etexilato mesilato somministrato per 3 giorni alla fine della terapia standard in successivi gruppi di bambini dai 2 a meno di 12 anni, e da 1 a meno di 2 anni
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and tolerability of dabigatran etexilate solution in children 1 to < 12 years of age
    sicurezza e la tollerabilita' di dabigatran etexilato in soluzione in pazienti pediatrici di eta' da 1 a meno di 12 anni.
    A.4.1Sponsor's protocol code number1160.89
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/175/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBOEHRINGER ING.
    B.1.3.4CountryItaly
    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 supportBoehringer Ingelheim Italia S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBoehringer Ingelheim Pharma GmbH & Co. KG
    B.5.2Functional name of contact pointQRPE PSC CT Information Disclosure
    B.5.3 Address:
    B.5.3.1Street AddressBinger Strasse 173
    B.5.3.2Town/ cityIngelheim am Rhein
    B.5.3.3Post code55216
    B.5.3.4CountryGermany
    B.5.4Telephone number+1-800-243-0127
    B.5.5Fax number+1-800-821-7119
    B.5.6E-mailclintriage.rdg@boehringer-ingelheim.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 No
    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 namedabigatran etexilate
    D.3.2Product code BIBR 1048 MS
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDABIGATRAN ETEXILATE
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeBIBR1048MS
    D.3.9.4EV Substance CodeSUB20521
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.38
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 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
    Venous Thrombotic Event
    tromboembolismo venoso
    E.1.1.1Medical condition in easily understood language
    Venous Thrombotic Event
    tromboembolismo venoso
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10014522
    E.1.2Term Embolism venous
    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
    This study is exploratory in nature and will investigate safety and tolerability of an oral liquid formulation of dabigatran etexilate in pediatric patients 1 to < 12 years old treated for primary VTE. The study will also provide preliminary pharmacokinetic and pharmacodynamic data for this age group.
    Questo studio e' di natura esplorativa e indaghera' la sicurezza e la tollerabilita' di una formulazione orale in liquido di dabigatran etexilato in successivi gruppi di pazienti pediatrici di eta' compresa tra 2 e &lt; 12 anni seguiti da 1 a &lt; 2 anni trattati per tromboembolismo venoso. Lo studio fornira' anche i dati preliminari di farmacocinatica e farmacodinamica per questa fascia di eta'
    E.2.2Secondary objectives of the trial
    none
    nessuno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Male or female children 1 to <12 years of age 2)Objective diagnosis of VTE 3)End of planned treatment course with low molecular weight heparin (LMWH) or oral anticoagulant (OAC) for VTE with INR and aPTT both within normal limits. End of planned treatment course is defined as the end of all need for anticoagulant therapy as per the standard of care at the investigational site. 4)Written informed consent provided by the patient’s parent (or legal guardian) and assent provided by the patient (if applicable) at the time of ICF signature. All informed consent / assent forms should be consistent with ICH / GCP and Local Institutional Review Board (IRB) requirements and must be obtained prior to any study procedures being performed.
    1)Maschi o femmine da 1 a &lt; 12 anni di eta' 2)Diagnosi obiettiva di TEV 3)Aver finalizzato il ciclo di trattamento pianificato con eparina di basso peso molecolare (HBPM) o anticoagulante orale (ACO) per il TEV con un INR e un aPTT entrambi entro i limiti della normalita'. La finalizzazione del ciclo di trattamento pianificato viene definito come la finalizzazione di ogni necessita' di terapia anticoagulante secondo lo standard di cura presso il centro sperimentale 4)Consenso informato scritto fornito dal genitore del paziente (o tutore legale) e assenso fornito dal paziente (se applicabile) al momento della firma del consenso informato. Tutti i moduli di consenso informato/assenso devono essere in accordo alle ICH/GCP e ai requisiti locali del Comitato Etico e devono essere ottenuti prima di qualsiasi procedura di studio
    E.4Principal exclusion criteria
    1) Weight less than 9 kg 2) Conditions associated with an increased risk of bleeding: a) Any hemorrhagic stroke b) Major surgery in the previous month c) Planned surgery or invasive procedure in the next 30 days d) History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra- articular bleeding e) Gastrointestinal haemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery) f) Any history of gastroduodenal ulcer disease g) Hemorrhagic disorder or bleeding diathesis h) Required concurrent treatment with another LMWH, UFH, oral anticoagulant or antiplatelet agent i) Fibrinolytic agents within 48 hours of study entry j) Uncontrolled hypertension on antihypertensive medication (systolic and/or diastolic above the upper limit of normal for age sustained over 24 h) 3) Severe renal dysfunction (eGFR < 80mL/min/1.73m2 using the Schwartz formula, refer to Appendix 10.1) or requirement for dialysis 4) Active infective endocarditis 5) Hepatic disease: a) INR >2.5 (>3.0 if on OAC) or an activated partial thromboplastin time (aPTT) >100 s or, b) Active liver disease, including known hepatitis A, B or C or, c) Persistent ALT, AST, Alk. Phos >2 x ULN 6)Females who have reached menarche with a positive pregnancy test or not using a medically accepted contraceptive method. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD); oral, implantable or injectable contraceptives and estrogen patch; double barrier method (spermacide + diaphragm); or abstinence at the discretion of the investigator. 7) Anaemia (haemoglobin <80g/L) or thrombocytopenia (platelet count <10080 x109/L). Transfusions are allowed to attain satisfactory levels. 8) Patients who have taken any prohibited / restricted medication / treatment (other than those used for planned VTE treatment) within one week of first dose of study medication. For trial restrictions please see Section 4.2.2. 9) Patients who have received an investigational drug in the past 30 days 10) Patients who are allergic / sensitive to any component of the study medication and/or solvent 11) Patients considered unreliable by the investigator concerning the requirements for followup during the study and / or compliance with study drug administration, or has any condition which in the opinion of the investigator, would not allow safe participation in the study.
    1)Peso inferiore a 9 kg 2)Condizioni associate ad un aumentato rischio di sanguinamento: a)Ogni ictus emorragico b)Chirurgia maggiore nel mese precedente c)Intervento chirurgico o procedura invasiva programmati nei prossimi 30 giorni d)Storia di sanguinamento intracranico, intraoculare, spinale, retroperitoneale o intra-articolare atraumatico e)Emorragia gastrointestinale nell corso dell'ultimo anno a meno che la causa sia stata definitivamente eliminata (ad esempio, da un intervento chirurgico) f)Qualsiasi storia di ulcera gastrointestinale g)Disturbi emorragici o diastesi emorragica h)Trattamento concomitante richiesto con un'altra eparina di basso peso molecolare, eparina non frazionata, anticoagulante orale o antiaggregante i)Agenti fibrinolitici entro 48 ore dall'entrata nello studio j)Ipertensione non controllata in terapia antipertensiva (sistolica e/o diastolica al di sopra del limite superiore del valore normale per l'eta' sostenuto oltre 24 ore) 3)Grave disfunzione renale (eGFR &lt; 80mL/min/1.73m2 utilizzando la formula di Schwartz (consultare l'Appendice 10.1) o necessita' di dialisi 4)Endocardite infettiva attiva 5)Malattia epatica: a)INR &gt; 2.5 (&gt;3.0 se in ACO) o aPTT &gt; 100 s o, b)Epatopatie in fase attiva, incluse l'epatite A, B o C o, c)Valori persistenti di ALT, AST, Alk. Phos &gt; 2 x ULN 6)Femmine che hanno raggiunto il menarca con un test di gravidanza positivo o che non stanno utilizzando un metodo contraccettivo clinicamente accettato. I metodi accettabili anticoncezionali sono limitati a: dispositivo intrauterino (DIU), contraccettivi orali, impiantabili o iniettabili e cerotto di estrogeni; metodo di doppia barriera (spermacide + diaframma); o l'astinenza a discrezione dello sperimentatore 7)Anemia (emoglobina &lt; 80g/L) o trombocitopenia (conta piastrinica &lt; 80 x 109/L). Le trasfusioni sono permesse per raggiungere livelli soddisfacenti. 8)Pazienti che hanno assunto trattamento proibito / limitato (diversi da quelli utilizzati per il trattamento previsto del TEV) entro una settimana dalla prima dose del farmaco in studio. Per le restrizioni dello studio vedere la Sezione 4.2.2 del protocollo di studio. 9)Pazienti che hanno ricevuto un farmaco sperimentale negli ultimi 30 giorni 10)Pazienti che sono allergici / sensibili a qualsiasi componente del farmaco in studio o solvente 11)Pazienti che, dal punto di vista dello sperimentatore, sono considerati inaffidabili in merito ai requisiti di follow-up durante lo studio e/o complianti rispetto alla somministrazione del farmaco in studio o che presentano qualsiasi condizione che, in base all'opinione dello sperimentatore, non avrebbe permesso una sicura partecipazione allo studio.
    E.5 End points
    E.5.1Primary end point(s)
    1) Incidence of all bleeding events, 2) Incidence of all adverse events. 3) Pharmacodynamic parameters: central and local measurement of TT 4) Pharmacokinetic parameters: plasma concentrations of total and free dabigatran, BIBR 1048 BS, BIBR 951BS, and BIBR 1087 SE,
    Endpoints di efficacia Non verranno eseguite misurazione sull'efficacia. Endpoints di sicurezza L'analisi di conferma non e' prevista per il trial attuale (vedere Sezione 7.2 del protocollo di studio). Endpoint primari di sicurezza 1)Incidenza di tutti gli eventi emorragici (maggiori e minori) 2)Incidenza di tutti gli eventi avversi Inoltre saranno valutati: 3)Parametri di farmacodinamica 4)Parametri di farmacocinetica
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoints 1) & 2) measured during screening, treatment period and 30 day followup. Endpoints 3) & 4) measured during screening (baseline) and treatment period.
    Endpoint 1 e 2: durante lo screening, il periodo di trattamento e 30 gg di followup Endpoint 3 e 4: durante lo screening ed il periodo di trattamento
    E.5.2Secondary end point(s)
    1) Changes in laboratory and clinical parameters such as liver enzymes, ECG, and physical examination, 2) Occurrences of clinical outcomes including recurrent thrombosis, post thrombotic syndrome (PTS), pulmonary emboli (PEs), and total and venous thrombolic event (VTE) related mortality, 3)Global assessment of tolerability to study medication (including patient taste assessment), 4) Pharmacodynamic parameters: local measurement of aPTT.
    -Cambiamenti nei parametri clinici di laboratorio come gli enzimi epatici, ECG, e l'esame fisico -Occorrenze di esiti clinici tra cui la trombosi ricorrente, sindrome post-trombotica (PTS), embolia polmonare (PE), e il tromboembolismo venoso totale e mortalita' correlata oggettivamente valutata, ad esempio con l'ecografia, la venografia o l'scanner (TC) (sulla base della posizione del trombo) -Valutazione globale della tollerabilita' al farmaco in studio (compresa la valutazione da parte del paziente del gusto)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoints 1) to 3) measured during screening, treatment period and 30 day followup. Endpoint 4) measured during screening (baseline) and treatment period.
    durante lo screening, il periodo di trattamento e 30 gg di followup
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    new pediatric formulation
    nuova formulazione in fascia pediatrica
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    Canada
    Singapore
    Switzerland
    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
    Sixteen patients who have completed the 30 day post treatment followup period.
    16 pazienti che devono completare il periodo di 30 giorni di folloup dopo il trattamento
    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 months8
    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 months13
    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.1.1Number of subjects for this age range: 33
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 16
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 17
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Parental/legal guardian consent and patient assent when applicable.
    pazienti minorenni con consnso firmato dal genitore/tutore legale ed assenso firmato dal paziente stesso
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 12
    F.4.2.2In the whole clinical trial 16
    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)
    no
    no
    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 Decision2012-02-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-25
    P. End of Trial
    P.End of Trial StatusCompleted
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