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    Summary
    EudraCT Number:2015-001098-42
    Sponsor's Protocol Code Number:ALX0681-C301
    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:2021-01-19
    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 number2015-001098-42
    A.3Full title of the trial
    A Phase III double-blind, randomized, parallel group, multicenter placebo-controlled trial to study the efficacy and safety of caplacizumab in patients with acquired thrombotic thrombocytopenic purpura
    Studio di Fase III Multicentrico, in Doppio Cieco, Randomizzato a Gruppi Paralleli con Placebo, per Studiare l¿Efficacia e la Sicurezza di Caplacizumab in Pazienti con Porpora Trombotica Trombocitopenica Acquisita.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III trial with caplacizumab in patients with acquired thrombotic thrombocytopenic purpura
    Studio di fase III con caplacizumab in pazienti con porpora trombotica trombocitopenica acquisita
    A.3.2Name or abbreviated title of the trial where available
    HERCULES
    ALX0681-C301
    A.4.1Sponsor's protocol code numberALX0681-C301
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02553317
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/60/2012
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorABLYNX NV
    B.1.3.4CountryBelgium
    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 supportAblynx NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAblynx NV
    B.5.2Functional name of contact pointAblynx Clinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressTechnologiepark 21
    B.5.3.2Town/ cityZwijnaarde
    B.5.3.3Post code9052
    B.5.3.4CountryBelgium
    B.5.4Telephone number32 (0) 9 262 00 00
    B.5.5Fax number32 (0) 9 262 00 35
    B.5.6E-mailclinicaltrials@ablynx.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 Yes
    D.2.5.1Orphan drug designation numberEU73/09/629
    D.3 Description of the IMP
    D.3.1Product nameCaplacizumab (an anti-von Willebrand Factor Nanobody)
    D.3.2Product code ALX-0081
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCaplacizumab
    D.3.9.1CAS number 915810-67-2
    D.3.9.2Current sponsor codeALX-0081
    D.3.9.3Other descriptive nameALX-0081
    D.3.9.4EV Substance CodeSUB91244
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11
    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 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 Yes
    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 Yes
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/629
    D.3 Description of the IMP
    D.3.1Product nameCaplacizumab
    D.3.2Product code ALX-0081
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCaplacizumab
    D.3.9.1CAS number 915810-67-2
    D.3.9.2Current sponsor codeALX-0081
    D.3.9.4EV Substance CodeSUB91244
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11
    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 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 Yes
    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 Yes
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/09/629
    D.3 Description of the IMP
    D.3.1Product nameCaplacizumab
    D.3.2Product code ALX-0081
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCaplacizumab
    D.3.9.1CAS number 915810-67-2
    D.3.9.2Current sponsor codeALX-0081
    D.3.9.4EV Substance CodeSUB91244
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number11
    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 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 Yes
    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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Acquired Thrombotic thrombocytopenic purpura
    Porpora Trombotica Trombocitopenica acquisita
    E.1.1.1Medical condition in easily understood language
    TTP is a rare condition in which the blood becomes "sticky" and forms clots within the blood vessels in different parts of the body.
    La PTT ¿ una condizione rara in cui il sangue diviene "appiccicoso" e forma coaguli all'interno dei vasi sanguigni in vari distretti del corpo
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10043648
    E.1.2Term Thrombotic thrombocytopenic purpura
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    For adults: To evaluate efficacy of caplacizumab in more rapidly restoring normal platelet counts as measure of prevention of further microvascular thrombosis.
    For pediatric subjects:To report the efficacy, safety, PK and PD properties and immunogenicity of caplacizumab in pediatric subjects experiencing an acute episode of acquired TTP.
    Per gli adulti: Valutare l'efficacia del caplacizumab nel riportare pi¿ rapidamente a conta di piastrine normali come misura preventiva di ulteriori trombosi microvascolari.
    Per soggetti pediatrici:
    Registrare l'efficacia, la sicurezza, le propriet¿ di PK e PD e l'immunogenicit¿ di caplacizumab in soggetti pediatrici che manifestano episodi acuti di PTT acquisita.
    E.2.2Secondary objectives of the trial

    -to evaluate the effect of study drug on a composite endpoint consisting of TTP-related mortality, recurrence of TTP and major thromboembolic events during study drug treatment
    -to evaluate the effect of study drug on prevention of recurrence of TTP over the entire study period
    -to evaluate the effect of study drug on refractoriness to treatment
    -to evaluate the effect of study drug on biomarkers of organ damage: lactate dehydrogenase (LDH), cardiac troponin I (cTnI), and serum creatinine
    -to evaluate the effect of study drug on PE parameters (days of PE and volume), days in intensive care unit (ICU), days in hospital

    -Valutare l¿effetto del farmaco in studio su un endpoint composito, costituito da mortalit¿ correlata a TTP, ricomparsa di TTP ed eventi tromboembolici rilevanti durante il trattamento con il farmaco in studio
    -valutare l¿effetto del farmaco in studio sulla prevenzione della ricomparsa di TTP nell¿arco dell¿intero periodo dello studio
    -valutare l¿effetto del farmaco in studio sulla refrattariet¿ al trattamento
    -valutare l'effetto del farmaco in studio sui biomarcatori di danno d'organo: lattato deidrogenasi (LDH), troponina I cardiaca (cTnI) e creatinina nel siero
    -valutare l¿effetto del farmaco in studio sui parametri relativi a PE (giorni di PE e volume), giorni in unit¿ di terapia intensiva (UTI), giorni in ospedale

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Adult male or female = 18 years of age at the time of signing the informed consent form (ICF) or,
    Male or female child (aged = 2 to < 12 years) or adolescent (aged = 12 to <18 years) at the time of obtaining informed consent/assent (as applicable).
    2.Clinical diagnosis of acquired TTP (initial or recurrent), which includes thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g. schistocytes)
    3.Requires initiation of daily PE treatment and has received PE treatment prior to randomization for adult subjects, and prior to start of first dose of study drug for pediatric subjects.
    - Adulti di sesso maschile o femminile = a 18 anni al momento della firma del consenso informato. (ICF) o
    Bambini (età da = 2 a < 12 anni) o adolescenti (età da = 12 a <18 anni) di sesso maschile o femminile al momento dell'ottenimento del consenso/assenso informato (come applicabile).
    - Diagnosi clinica di PTT acquisita (iniziale o ricorrente)che includa trombocitopenia e evidenza microscopica di frammentazione dei globulirossi (e.g. shistociti).
    -Richiede l'inizio di trattamento di Plasmaferesi giornaliera ed ah ricevuto almento un trattamento di PE prima della randomizzazione per i soggetti adulti e prima dell'inizio della somministrazione della prima dose di farmaco in studio per i soggetti pediatrici.
    E.4Principal exclusion criteria
    1.Platelet count =100×10E9/L
    2.Serum creatinine level >200 µmol/L in case platelet count is >30×109/L
    3.Known other causes of thrombocytopenia
    -conta piastrinica =100×10E9/L
    -livello di creatinina sierica >200 µmol/L se conta piastrinica >30×109/L
    -altre cause note di trombocitopenia
    E.5 End points
    E.5.1Primary end point(s)
    Applicable for adults only:Time to platelet count response defined as initial platelet count = 150×109/L with subsequent stop of daily PE within 5 days.
    Pediatric subjects
    Data of pediatric subjects will be analyzed separately from data of adult subjects. No endpoints are defined for the pediatric subjects. Data will be analyzed descriptively.
    Applicabili solo per gli adulti; Tempo alla risposta della conta piastrinica definito come conta piastrinica iniziale = 150×109/L con successiva interruzione della PE giornaliera entro 5 giorni.
    I dati dei soggetti pediatrici saranno analizzati separatamente dai dati dei soggetti adulti. Non sono definiti endpoint per i soggetti pediatrici. I dati saranno analizzati in modo descrittivo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Daily PE period, for maximum 6 months
    Tempo di PE giornaliera, per massimo 6 mesi
    E.5.2Secondary end point(s)
    1. Proportion of subjects with TTP-related death, a recurrence of TTP, or
    at least one treatment-emergent major thromboembolic event during the
    study drug treatment period (including extensions).
    2. Proportion of subjects with a recurrence of TTP in the overall study
    period (including 4-week FU period).
    3. Proportion of subjects with refractory TTP, defined as absence of
    platelet count doubling after 4 days of standard treatment, and LDH
    >ULN
    4. Time to normalization of all 3 of the following organ damage marker
    levels:
    - Time to LDH = 1 x upper limit of normal (ULN), and
    - Time to cTnI = 1 x ULN, and
    - Time to serum creatinine = 1 x ULN
    1. Proporzione di soggetti con decesso correlato a PTT, ricomparsa di PTT, o almeno un evento tromboembolico rilevante emergente dal trattamento (per esempio infarto miocardico, evento cerebrovascolare, embolia polmonare o trombosi venosa profonda [DVT]; Si veda anche la Sezione 3.4.3.6) durante il trattamento con il farmaco in studio (incluse estensioni).
    2. Proporzione di soggetti con una ricomparsa di PTT nel periodo complessivo dello studio (incluso il periodo fi FU di 4 settimane)
    3. Proporzione di soggetti con PTT refrattaria definita come mancato raddoppio della conta piastrinica dopo 4 giorni di trattamento standard e LDH > ULN
    4. Tempo alla normalizzazione di tutti e 3 i seguenti livelli di marcatori del danno d'organo:
    - Tempo al livello di LDH = 1 x il limite superiore della norma (ULN) e
    - livello di cTnI = 1 x ULN e
    - livello di creatinina nel siero = 1 x ULN
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. During the treatment period (ie daily PE period + post-daily PE
    treatment period)
    2. During the overall study period (including the FU period)
    3. Will be evaluated during the daily PE period
    4. During the overall study period (including the FU period)
    1. Durante il periodo di trattamento (ie periodo di PE giornaliera + periodo di trattamento post PE-giornaliera
    2.Durante tutta la durata dello studio (incluso il periodo di FU)
    3.Verr¿ valutato durante il periodo di PE-giornaliera
    4. Durante tutta la durata dello studio (incluso il periodo di FU)
    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 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Per bambini & adolescenti trattamento open-label con Caplacizumab
    For children & Adolescents open-label treatment with Caplacizumab
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA47
    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
    Australia
    Canada
    Israel
    New Zealand
    Turkey
    United States
    Austria
    Belgium
    Czechia
    France
    Germany
    Hungary
    Italy
    Netherlands
    Spain
    Switzerland
    United Kingdom
    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 years2
    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 years2
    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.1.1.5.1Number of subjects for this age range: 5
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 119
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Adults with a clinical diagnosis of acquired TTP who require initiation of daily PE treatment.It is possible that patients were brought to the hospital unconscious and therefore unable to sign or give their consent.
    Adulti con una diagnosi clinica di PTT acquisita ceh richiedono un inizio di trattamento di PE quotidiano. E' possibile che i pazienti siano stati portati in ospedale incoscienti quindi risultano non in grado di firmare o dare il consenso
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 74
    F.4.2.2In the whole clinical trial 132
    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)
    standard of care
    secondo prassi clinica
    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 Decision2015-10-14
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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