Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   42316   clinical trials with a EudraCT protocol, of which   6969   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-005554-23
    Sponsor's Protocol Code Number:1199-0378
    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:2022-01-28
    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 number2020-005554-23
    A.3Full title of the trial
    An open-label trial of the long-term safety and tolerability of nintedanib per os, on top of standard of care, over at least 2 years, in children and adolescents with clinically significant fibrosing Interstitial Lung Disease (InPedILD™-ON)
    Studio in aperto a lungo termine per valutare la sicurezza e la tollerabilità di nintedanib per os, in aggiunta a terapia standard, per almeno 2 anni in bambini e adolescenti con malattia polmonare interstiziale fibrosante clinicamente significativa. (InPedILD™-ON)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate long-term safety of nintedanib in children and adolescents with interstitial lung disease (InPedILD™-ON)
    Studio per valutare la sicurezza a lungo termine di nintedanib in bambini e adolescenti con malattia polmonare interstiziale (InPedILD™-ON).
    A.3.2Name or abbreviated title of the trial where available
    InPedILD™-ON
    InPedILD™-ON
    A.4.1Sponsor's protocol code number1199-0378
    A.5.4Other Identifiers
    Name:-Number:-
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/150/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBOEHRINGER-INGELHEIM ITALIA S.P.A.
    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 pointCT Disclosure & Data Transparency
    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 number00498002430127
    B.5.5Fax number00498008217119
    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 Yes
    D.2.1.1.1Trade name Ofev®
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International 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 nameNintedanib 100 mg capsules
    D.3.2Product code [Nintedanib]
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    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 INNNINTEDANIB
    D.3.9.1CAS number 656247-17-5
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB120728
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.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 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 nameNintedanib 25 mg capsules
    D.3.2Product code [Nintedanib]
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    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 INNNINTEDANIB
    D.3.9.1CAS number 656247-17-5
    D.3.9.2Current sponsor codeNINTEDANIB
    D.3.9.4EV Substance CodeSUB120728
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 3
    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 Ofev®
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International 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 nameNintedanib 150 mg capsules
    D.3.2Product code [Nintedanib]
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    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 INNNINTEDANIB
    D.3.9.1CAS number 656247-17-5
    D.3.9.2Current sponsor codeNintedanib
    D.3.9.4EV Substance CodeSUB120728
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    Interstitial Lung Disease
    malattia polmonare interstiziale fibrosante clinicamente significativa
    E.1.1.1Medical condition in easily understood language
    Interstitial Lung Disease
    malattia polmonare interstiziale fibrosante clinicamente significativa
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10066393
    E.1.2Term Respiratory bronchiolitis-associated interstitial lung disease
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The trial will assess the safety and tolerability of long-term treatment
    with nintedanib in pediatric patients with clinically significant fibrosing ILD.
    The primary objective is to estimate the incidence of treatment emergent
    adverse events over the whole trial.
    l’obiettivo principale dello studio è di valutare la sicurezza e tollerabilità a lungo termine del trattamento con nintedanib in pazienti pediatrici con malattia polmonare interstiziale fibrosante clinicamente significativa.
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: HRCT substudy:
    only at selected sites in the United States (US) for patients who already
    participated in the similar substudy in the parent trial
    Details of the planned HRCT analyses and endpoints will be described in
    a specific Statistical Analysis Plan (SAP) for the substudy and are
    considered exploratory.

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Sottostudio HRCT:
    solo in siti selezionati negli Stati Uniti (USA) per i pazienti che già hanno
    partecipato al sottostudio simile nella sperimentazione madre
    I dettagli delle analisi HRCT pianificate e degli endpoint saranno descritti in
    uno specifico Piano di Analisi Statistica (SAP) per il sottostudio e sono
    considerate esplorative.
    E.3Principal inclusion criteria
    For new patients:
    1. Children and adolescents 6 to 17 years old at Visit 2.
    2. Signed and dated written informed consent and assent, where
    applicable, in accordance with ICH-GCP and local legislation prior to
    admission to the trial.
    3. Male or female patients. Female of childbearing potential (WOCBP1)
    must confirm that sexual abstinence is standard practice and will be
    continued until 3 months after last drug intake, or be ready and able to
    use a highly effective method of birth control per ICH M3 (R2) that
    results in a low failure rate of less than 1% per year when used
    consistently and correctly, in combination with one barrier method, from 28 days prior to initiation of study treatment, during treatment and until
    3 months after last drug intake. Sexual abstinence is defined as
    abstinence from any sexual act that may result in pregnancy.
    4. Patients with evidence of fibrosing ILD on HRCT within 12 months of
    Visit 1 as assessed by the investigator and confirmed by central review.
    5. Patients with FVC % predicted =25% at Visit 2.
    6. Patients with clinically significant disease at Visit 2, as assessed by
    the investigator based on any of the following:
    - Fan score =3, or
    - Documented evidence of clinical progression over time based on either
    o a 5-10% relative decline in FVC% predicted accompanied by
    worsening symptoms, or
    o a =10% relative decline in FVC % predicted, or
    o increased fibrosis on HRCT, or
    o other measures of clinical worsening attributed to progressive lung
    disease
    For roll-over patients from the InPedILD™ study:
    Only criteria 2 and 3 listed for new patients are applicable with the
    following additional inclusion criterion:
    7. Patients who completed the InPedILD™ trial as planned and who did
    not permanently prematurely discontinue study treatment.
    For patients who discontinued treatment permanently in 1199-0337 but
    are potentially eligible:
    Criteria for new patients are applicable except criteria 4, and 6
    Per i nuovi pazienti:
    1. Bambini e adolescenti dai 6 ai 17 anni di età alla Visita 2.
    2. Consenso informato scritto firmato e datato e assenso, ove applicabile, prima dell’inclusione nella sperimentazione, in conformità alle norme ICH-GCP e alla normativa locale.
    3. Pazienti di ambo i sessi. Per la donna potenzialmente fertile andrà confermata l’astinenza sessuale come pratica che verrà osservata fino a 3 mesi dopo l’ultima assunzione del farmaco, oppure andrà confermato che è disposta e in grado di utilizzare un metodo contraccettivo altamente efficace secondo le linee guida ICH M3 (R2), con una percentuale di insuccesso inferiore all’1% all’anno se usato in modo coerente e corretto, in combinazione con un metodo barriera da 28 giorni prima dell’inizio del trattamento in studio, durante tutto il trattamento e fino a 3 mesi dopo l’ultima assunzione del farmaco. L’astinenza sessuale è definita come l’astinenza da qualsiasi rapporto sessuale che potrebbe portare ad una gravidanza. Una lista dei metodi contraccettivi che corrispondono a questi criteri è riportata nella sezione 4.2.2.3 del protocollo.
    4. Pazienti con evidenza di ILD fibrosante all’HRCT entro 12 mesi dalla Visita 1, valutata dallo sperimentatore e confermata da una revisione centralizzata.
    5. Pazienti con FVC prevista = 25% alla Visita 2.
    Nota: i valori normali previsti saranno calcolati secondo la GLI (Global Lung Initiative).
    6. Pazienti con malattia clinicamente significativa alla Visita 2, valutata dallo sperimentatore in base a uno dei seguenti criteri:
    • Fan score =3 oppure
    • Evidenza documentata di progressione clinica nel tempo basata su:
    o un declino relativo del 5-10% della FVC prevista, accompagnato da un peggioramento dei sintomi; oppure
    o un declino relativo =10% della FVC prevista; o
    o un aumento della fibrosi all’HRCT; oppure
    o altre misure di peggioramento clinico attribuite alla malattia polmonare progressiva (ad es. aumento del fabbisogno di ossigeno, diminuzione della capacità di diffusione).

    Per i pazienti che fanno roll-over dallo studio InPedILD™ (1199-0337):

    Si applicano solo i criteri 2 e 3 per i nuovi pazienti con l’aggiunta del seguente criteri

    7. Pazienti che hanno completato lo studio InPedILD™ (1199-0337) come previsto e che non sono stati permanentemente discontinuati dal trattamento di studio

    Per i pazienti che hanno interrotto in modo permanente il trattamento nello studio 1199-0337 ma sono potenzialmente eleggibili:

    Si applicano tutti i criteri per i nuovi pazienti eccetto i criteri 4 e 6 (poiché l’eleggibilità per questi criteri è già stata verificate nello studio 1199-0337 e non è necessario che venga riverificata).
    E.4Principal exclusion criteria
    For new patients:
    1. AST and/or ALT >1.5 x ULN at Visit 1.
    2. Bilirubin >1.5 x ULN at Visit 1.
    3. eGFR <30 mL/min calculated by Schwartz formula at Visit 1
    4. Patients with underlying chronic liver disease (Child Pugh A, B or C
    hepatic impairment) at Visit 1.
    5. Other investigational therapy received within 1 month or 5 half-lives
    (whichever is shorter but =1 week) prior to Visit 2 except investigational
    therapy received in InPedILD™ trial.
    6. Significant pulmonary arterial hypertension (PAH) defined by any of
    the following:
    a. Previous clinical or echocardiographic evidence of significant right
    heart failure
    b. History of right heart catheterization showing a cardiac index =2
    l/min/m²
    c. PAH requiring parenteral therapy with epoprostenol/treprostinil
    7. In the opinion of the Investigator, other clinically significant
    pulmonary abnormalities.
    8. Cardiovascular diseases, any of the following:
    a. Severe hypertension, uncontrolled under treatment, within 6 months
    of Visit 1.
    Uncontrolled hypertension is defined as
    i. In children 6 to =12 years old: =95th percentile + 12 mm Hg or =
    140/90 mm Hg
    (whichever is lower) (systolic or diastolic blood pressure equal to or
    greater than
    the calculated target value) (please refer to Appendix 10.5)
    ii. In adolescents 13 to 17 years old: systolic blood pressure =140 mm
    Hg or diastolic blood pressure =90 mm Hg (please refer to Appendix 10.5)
    b. Myocardial infarction within 6 months of Visit 1
    c. Unstable cardiac angina within 6 months of Visit 1
    9. Bleeding risk, any of the following:
    a. Known genetic predisposition to bleeding
    b. Patients who require
    i. Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K
    antagonists, direct thrombin inhibitors, heparin, hirudin)
    ii. High dose antiplatelet therapy
    c. History of haemorrhagic central nervous system (CNS) event within 12
    months of Visit 1
    d. Any of the following within 3 months of Visit 1:
    i. Haemoptysis or haematuria
    ii. Active gastro-intestinal (GI) bleeding or GI – ulcers
    iii. Major injury or surgery (investigator's judgment)
    e. Any of the following coagulation parameters at Visit 1:
    i. International normalized ratio (INR) >2
    ii. Prolongation of prothrombin time (PT) by >1.5 x ULN
    iii. Prolongation of activated partial thromboplastin time (aPTT) by >1.5
    x ULN
    10. History of thrombotic event (including stroke and transient ischemic
    attack) within 12 months of Visit 1.
    For other criteria, see protocol
    Per i nuovi pazienti:
    1. AST e/o ALT >1,5 x ULN alla Visita 1.
    2. Bilirubina >1,5 x ULN alla Visita 1.
    3. Clearance della creatinina calcolata mediante la formula di Schwartz <30 ml/min alla Visita 1.
    [Nota: dalla Visita 1, i parametri di laboratorio devono soddisfare i valori soglia indicati sopra. Visita 2: i risultati di laboratorio saranno disponibili solo dopo la randomizzazione. Nel caso in cui durante la Visita 2 i risultati non soddisfino più i criteri di eleggibilità, lo sperimentatore dovrà decidere se la permanenza del paziente nel trattamento è giustificata. La giustificazione della decisione deve essere documentata. I parametri di laboratorio risultati anormali alla Visita 1 possono essere nuovamente analizzati (una sola volta) se si ritiene che si tratti di un errore di misurazione (ad esempio se non vi è stato alcun risultato anomalo di questo test nella storia clinica recente del paziente e non vi è alcun segno clinico correlato) o del risultato di una condizione medica temporanea e reversibile (in questo casi il test verrà ripetuto una volta che questa condizione è risolta).]
    4. Pazienti con epatopatia cronica (di grado A, B o C secondo la classificazione Child Pugh) alla Visita 1.
    5. Altra terapia sperimentale ricevuta entro 1 mese o 5 emivite (a seconda di quale sia più breve ma =1 settimana) prima della Visita 2, ad eccezione della terapia sperimentale ricevuta nello studio InPedILD™.
    6. Ipertensione arteriosa polmonare significativa, definita da uno dei seguenti criteri:
    a. Precedente evidenza clinica o ecocardiografica di insufficienza cardiaca destra significativa
    b. Storia di cateterizzazione cardiaca destra che mostra un indice cardiaco =2 l/min/m²
    c. Ipertensione arteriosa polmonare che richiede la terapia parenterale con epoprostenolo/treprostinil
    7. Altre anomalie polmonari clinicamente significative secondo il parere dello sperimentatore.
    8. Una qualsiasi delle seguenti malattie cardiovascolari:
    a. Ipertensione grave, non controllata durante dalla terapia medica, entro 6 mesi dalla Visita 1. L’ipertensione non controllata è definita come segue:
    i. Nei bambini da 6 a =12 anni: =95º percentile + 12 mmHg o =140/90 mmHg (a seconda di quale sia inferiore) (pressione arteriosa sistolica o diastolica pari o superiore al valore target calcolato)
    ii. Negli adolescenti di età compresa tra 13 e 17 anni: pressione arteriosa sistolica =140 mmHg o pressione diastolica =90 mmHg
    b. Infarto miocardico entro 6 mesi dalla Visita 1
    c. Angina instabile entro 6 mesi dalla Visita 1
    9. Rischio di sanguinamento associato a una delle seguenti condizioni:
    a. Predisposizione genetica nota al sanguinamento
    b. Pazienti che richiedono:
    i. fibrinolisi, terapia anticoagulante a dosaggio pieno (ad es. antagonisti della vitamina K, inibitori diretti della trombina, eparina, irudina)
    ii. Terapia antipiastrinica ad alto dosaggio
    [Nota: non sono vietati la profilassi con eparina a basso dosaggio o flush di eparina al bisogno per la manutenzione di un dispositivo endovenoso fisso (ad es. enoxaparina 4000 UI s.c./die) e l’uso profilattico della terapia antipiastrinica (ad es. acido acetilsalicilico fino a 325 mg/die o clopidogrel alla dose di 75 mg/die o dosi equivalenti di un’altra terapia antipiastrinica).]
    c. Storia di evento emorragico a carico del sistema nervoso centrale (SNC) entro 12 mesi dalla Visita 1
    d. Una qualsiasi delle seguenti condizioni entro 3 mesi dalla Visita 1:
    i. Emottisi o ematuria
    ii. Sanguinamento gastrointestinale (GI) attivo o ulcere GI
    iii. Lesioni o interventi chirurgici importanti (secondo il parere dello sperimentatore)
    e. Uno qualsiasi dei seguenti parametri di coagulazione alla Visita 1:
    i. INR (International Normalized Ratio) >2
    ii. PT (Prothrombin Time) >1,5 x ULN
    iii. aPTT (activated Partial Thromboplastin Time) >1,5 x ULN
    10. Storia di evento trombotico (inclusi ictus e attacco ischemico transitorio) entro 12 mesi dalla Visita 1.
    Per gli altri criteri, fare riferimento alla sinossi in italiano
    E.5 End points
    E.5.1Primary end point(s)
    1) The primary endpoint is the incidence of treatment emergent adverse
    events over the whole trial.
    1) L'endpoint primario è l'incidenza degli eventi avversi emergenti dal trattamento durante l'intero studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Whole trial duration
    1) l'intero studio.
    E.5.2Secondary end point(s)
    None
    nessuno
    E.5.2.1Timepoint(s) of evaluation of this end point
    None
    nessuno
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 Yes
    E.8.1.7.1Other trial design description
    In aperto
    Open
    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 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 EEA18
    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
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    Czechia
    Denmark
    Finland
    France
    Germany
    Greece
    Hungary
    Italy
    Mexico
    Netherlands
    Norway
    Poland
    Portugal
    Russian Federation
    Spain
    Ukraine
    United Kingdom
    United States
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days1
    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.1.1.5.1Number of subjects for this age range: 18
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 38
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 4
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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)
    None
    nessuno
    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 Decision2022-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-12
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA