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    Summary
    EudraCT Number:2019-000906-31
    Sponsor's Protocol Code Number:IgPro10_2001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-01-22
    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 number2019-000906-31
    A.3Full title of the trial
    A Randomized, Multicenter, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of IgPro10 (Intravenous Immunoglobulin, Privigen®) for the Treatment of Adults with Systemic Sclerosis
    Studio di fase 2, randomizzato, multicentrico, in doppio cieco, controllato con placebo, per valutare l'efficacia e la sicurezza di IgPro10 (immunoglobulina per via endovenosa, Privigen®) per il trattamento di adulti con sclerosi sistemica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of IgPro10 in Adults with Systemic Sclerosis (SSc)
    Efficacia e sicurezza di IgPro10 negli adulti con sclerosi sistemica
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberIgPro10_2001
    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 SponsorCSL BEHRING GMBH
    B.1.3.4CountryGermany
    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 supportCSL Behring GmbH (CSLB)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCSLB
    B.5.2Functional name of contact pointTrial Registration Coordinator
    B.5.3 Address:
    B.5.3.1Street Address1020 First Ave
    B.5.3.2Town/ cityKing of Prussia,PA
    B.5.3.3Post code19406
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016108784000
    B.5.5Fax number000000
    B.5.6E-mailclinicaltrials@cslbehring.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 PRIVIGEN - 100 MG/ML - SOLUZIONE PER INFUSIONE USO ENDOVENOSO FLACONCINO(VETRO) 1 FLACONCINO DA 100 ML
    D.2.1.1.2Name of the Marketing Authorisation holderCSL BEHRING 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 nameImmunoglobulina normale umana per somministrazione endovenosa
    D.3.2Product code [IgPro10]
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeIgPro10
    D.3.9.4EV Substance CodeSUB14196MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Yes
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    efficacy and safety in subjects with diffuse cutaneous systemic sclerosis
    efficacia e sicurezza in soggetti con sclerosi sistemica diffusa cutanea
    E.1.1.1Medical condition in easily understood language
    scleroderma
    scleroderma
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10012977
    E.1.2Term Diffuse systemic sclerosis
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10010331
    E.1.2Term Congenital, familial and genetic disorders
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the efficacy of IgPro10 in comparison to placebo in adults with Diffuse systemic sclerosis (dcSSc) assessed by improvement as measured by American College of Rheumatology Combined Response Index in Diffuse Systemic Sclerosis (ACR CRISS) score.
    L’obiettivo primario è di valutare l’efficacia di IgPro10 rispetto al placebo in adulti con sclerosi sistemica diffusa cutanea (dcSSc) valutata in base al miglioramento misurato con il punteggio dell’Indice di risposta combinato per la sclerosi sistemica diffusa (American College of Rheumatology Combined Response Index in Diffuse Systemic Sclerosis, ACR CRISS).
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to evaluate:
    1. To further assess the efficacy of IgPro10 as compared to placebo
    2. To assess safety of IgPro10 as compared to placebo
    3. To assess the IgPro10 concentrations at steady state
    4. To assess longer term efficacy and safety of IgPro10 at the end of an OL Treatment Period at Week 72.
    Gli obiettivi secondari dello studio consistono nella valutazione di:
    1. Valutare ulteriormente l’efficacia di IgPro10 rispetto al placebo
    2. Valutare la sicurezza di IgPro10 rispetto al placebo
    3. Valutare le concentrazioni di IgPro10 allo stato stazionario
    4. Valutare l’efficacia e la sicurezza a più lungo termine di IgPro10 alla conclusione di un periodo di trattamento in aperto alla settimana 72.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age =18 years (male or female) at time of providing written informed consent
    2. Documented diagnosis of dcSSc according to ACR / EULAR criteria 2013
    3. mRSS = 15 and = 45
    4. Disease duration = 5 years defined as the time from the first non-Raynaud's phenomenon manifestation
    5. Subjects within first 18 months of disease duration from first non-Raynaud's phenomenon manifestation. For those >18 to = 60 months, subjects with worsening of sclerodermatous skin involvement in one or more body areas (including any new areas of involvement) within 6 months prior to Screening and/or the presence of a tendon friction rub within 3 months prior to Screening as documented and determined by the investigator based on medical history and medical records
    1. Età = 18 anni (maschio o femmina) al momento del consenso informato scritto
    2. Diagnosi documentata di dcSSc secondo i criteri ACR /EULAR del 2013
    3. mRSS = 15 e = 45
    4. Durata della malattia = 5 anni definita come tempo dalla manifestazione del primo sintomo non Raynaud
    5. Soggetti nei primi 18 mesi di durata della malattia dalla manifestazione del primo sintomo non Raynaud. Da >18 a = 60 mesi, soggetti con peggioramento della sclerodermia in una o più aree del corpo (compreso il coinvolgimento di nuove aree) entro 6 mesi dallo screening e/o presenza di sfregamento tendineo entro 3 mesi dallo screening documentati e determinati dallo sperimentatore in base all’anamnesi e alla cartella clinica
    E.4Principal exclusion criteria
    1. Primary rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disorder, polymyositis, and dermatomyositis, as determined by the investigator
    Note: Subjects with fibromyalgia, secondary Sjogren's syndrome, and scleroderma-associated myopathy or myositis at Screening are not excluded
    2. Positive anti-centromere autoantibodies at Screening
    3. Evidence of severe chronic kidney disease with estimated glomerular filtration rate < 45 mL/min/1.73m2 (as calculated by the Chronic Kidney Disease Epidemiology Collaboration equation) or receiving dialysis.
    Additionally, subjects with current confirmed diagnosis of diabetes
    mellitus and requiring medication, with eGFR < 90 mL/min/1.73m2 will
    be excluded from the study.
    Additionally, subjects with current confirmed diagnosis of diabetes mellitus and requiring medication, with eGFR < 90 mL/min/1.73m2 will be excluded from the study.
    4. History of documented thrombotic episode eg, PE, DVT, myocardial infarction, thromboembolic stroke at any time.
    Note: past superficial thrombophlebitis more than two years from Screening is not exclusionary
    5. Documented thrombophilic abnormalities including blood hyperviscosity, protein S or protein C deficiency, anti-thrombin-3 deficiency, plasminogen deficiency, antiphospholipid syndrome, Factor V Leiden mutation, dysfibrinogenemia, or prothrombin G20210A mutation
    6. Greater than 3 specified current risk factors for TEEs (documented and currents conditions): atrial fibrillation, coronary disease, diabetes mellitus, dyslipidemia, hypertension, obesity (Body Mass Index = 30 kg/m2), recent significant trauma, and immobility (wheelchair-bound or bedridden)
    7. Ongoing active serious infection at Screening (including, but not limited to, pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess)
    8. Malignancy in the past 2 years, except for non-melanoma skin cancer, cervical carcinoma in situ, or other in situ cancer if it has been excised and treated within in the past year
    9. Known hypoalbuminemia, protein-losing enteropathies, and any proteinuria (defined by total urine protein concentration > 0.2 g/L)
    10. Known IgA deficiency or serum IgA level < 5% lower limit of normal
    11. Known or suspected antibodies to the IP, or to excipients of the IP.
    1. Malattia reumatica autoimmune primaria diversa da dcSSc, inclusi a titolo esemplificativo artrite reumatoide, lupus eritematoso sistemico, malattia mista del tessuto connettivo, polimiosite, dermatomiosite, secondo la valutazione dello sperimentatore
    Nota: I soggetti con fibromialgia, sindrome di Sjogren secondaria e miopatia o miosite associate a sclerodermia allo screening non sono esclusi
    2. Presenza di anticorpi anti-centromero allo screening
    3. Evidenza di malattia renale cronica severa con velocità di filtrazione glomerulare stimata < 45mL/min/1,73m2 (calcolata secondo l’equazione Chronic Kidney Disease Epidemiology Collaboration) o in trattamento con dialisi.
    Inoltre, i soggetti con l'attuale diagnosi confermata di diabete mellito e che richiedono farmaci, con eGFR <90 mL / min / 1.73m2 essere escluso dallo studio.
    4. Anamnesi di episodi trombotici documentati, ad es. PE, DVT, infarto del miocardio, ictus tromboembolico in qualsiasi momento
    Nota: una tromboflebite superficiale pregressa a oltre due anni dallo screening non determina l’esclusione
    5. Anomalie trombofiliche documentate tra cui iperviscosità ematica, deficit di proteina S o C, deficit di antitrombina III, deficit di plasminogeno, sindrome antifosfolipidica, mutazione del Fattore V di Leiden, disfibrinogenemia o mutazione della protrombina G20210A
    6. Oltre 3 fattori di rischio attuali specificati di eventi tromboembolici (TEE) (condizioni attuali e documentate): fibrillazione atriale, malattia coronarica, diabete mellito, dislipidemia, ipertensione, obesità (Indice di massa corporea = 30 kg/m2), recente trauma significativo e immobilità (su sedia a rotelle o allettato)
    7. Infezioni attive gravi in corso al momento dello screening (inclusi a titolo esemplificativo polmonite, batteriemia/setticemia, osteomielite/artrite settica, meningite batterica o ascesso viscerale)
    8. Neoplasia maligna negli ultimi 2 anni, fatta eccezione per carcinoma cutaneo non melanoma, carcinoma cervicale in situ, o altro carcinoma in situ qualora sia stato resecato e trattato nel corso dell’anno precedente
    9. Ipoalbuminemia nota, enteropatie proteino-disperdenti e qualsiasi proteinuria (definita dalla concentrazione proteica totale nelle urine > 0,2 g/L)
    10. Deficit di IgA noto o livello sierico di IgA < 5% del limite inferiore di normalità
    11. Presenza nota o sospetta di anticorpi contro l’IP o contro gli eccipienti dell’IP.
    E.5 End points
    E.5.1Primary end point(s)
    Response on American College of Rheumatology Combined Response Index in Diffuse Systemic Sclerosis (ACR CRISS) score in IgPro10 vs Placebo
    Risposta in base al punteggio dell’Indice di risposta combinato per la sclerosi sistemica diffusa (American College of Rheumatology Combined Response Index in Diffuse Systemic Sclerosis, ACR CRISS) nel braccio IgPro10 vs placebo
    E.5.1.1Timepoint(s) of evaluation of this end point
    over 48 weeks
    oltre 48 settimane
    E.5.2Secondary end point(s)
    1. Proportion of subjects meeting cardiopulmonary or renal failure criteria in ACR CRISS Step 1 events
    2. Proportion of responders (ACR CRISS > 0.6)
    3. Mean change from Baseline in Modified Rodnan Skin Score (mRSS)
    4. Mean change from Baseline in Health Assessment Questionnaire – Disability Index (HAQ-DI)
    5. Mean change from Baseline in Forced Vital Capacity (FVC)% predicted
    6. Mean change from Baseline in Physician Global Assessment (MDGA)
    7. Mean change from Baseline in Patient Global Assessment (PGA)
    8. Mean change from Baseline in UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract 2.0 (UCLA SCTC GIT 2.0) total score and subscale
    9. Mean change from Baseline in Scleroderma Skin Patient Reported Outcome (SSPRO) score in IgPro10 vs Placebo
    10. Proportion of responders in mRSS
    11. Time to treatment failure(time from first infusion to time of first event) in IgPro10 vs Placebo
    12. Proportion of subjects with events at Week 48 in IgPro10 vs Placebo
    13. Mean change from Baseline in Cochin Hand Function Scale in IgPro10 vs Placebo
    14. Mean change from Baseline in Scleroderma Health Assessment Questionnaire (SHAQ) score in IgPro10 vs Placebo
    15. Mean change from baseline in muscle strength as measured by Manual Muscle Testing 8 (MMT) in IgPro10 vs Placebo
    16. Number of subjects with adverse events (AEs) including any AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)
    17. Percentage of subjects with AEs, TEAEs, SAEs, AESIs
    18. Change in Vital signs
    19. Change in body weight
    20. Change in Electrocardiogram (ECG)
    21. Change in pulmonary function tests ( PFTs)
    22. Serum trough IgG levels at Baseline and prior to first infusion
    23. Proportion of responders (ACR CRISS > 0.6)
    24. Mean change from Baseline in mRSS
    25. Mean change from Baseline in HAQ-DI
    26. Mean change from Baseline in Forced Vital Capacity (FVC)% predicted
    27. Mean change from Baseline in MDGA
    28. Mean change from Baseline in PGA
    29. Number of subjects with adverse events (AEs) including any AEs, treatment-emergent AEs (TEAEs), serious AEs (SAEs), and AEs of special interest (AESIs)
    30. Percentage of subjects with AEs, TEAEs, SAEs, AESIs
    31. Change in Vital signs
    32. Change in Electrocardiogram (ECG)
    33. Change in FVC and DLCO
    1. Percentuale di soggetti che soddisfano i criteri di insufficienza cardiopolmonare o renale nella valutazione ACR CRISS Step 1
    2. Percentuale di responder (ACR CRISS > 0,6)
    3. Variazione media dal basale del punteggio Modified Rodnan Skin Score (mRSS)
    4. Variazione media dal basale del Health Assessment Questionnaire-Disability Index (HAQ-DI)
    5. Variazione media dal basale della % prevista di capacità vitale forzata (FVC)
    6. Variazione media dal basale della Valutazione globale del medico (MDGA)
    7. Variazione media dal basale della Valutazione globale del paziente (PGA)
    8. Variazione media dal basale del punteggio totale e della sotto-scala del questionario UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract 2.0 (UCLA SCTC GIT 2.0)
    9. Variazione media dal basale del punteggio dei Risultati riferiti dai pazienti con sclerodermia (SSPRO) nel braccio IgPro10 vs placebo
    10. Percentuale di responder in mRSS
    11. Tempo al fallimento del trattamento (tempo dalla prima infusione al primo evento) nel braccio IgPro10 vs placebo
    12. Percentuale di soggetti con eventi alla settimana 48 nel braccio IgPro10 vs placebo
    13. Variazione media dal basale della Scala Cochin Hand Function Scale nel braccio IgPro10 vs placebo
    14. Variazione media dal basale del punteggio dello Scleroderma Health Assessment Questionnaire (SHAQ) nel braccio IgPro10 vs placebo
    15. Variazione media dal basale della forza muscolare misurata con il Test muscolare manuale 8 (MMT) nel braccio IgPro10 vs placebo
    16. Numero di soggetti con eventi avversi (AE) tra cui qualsiasi AE, eventi avversi emergenti dal trattamento (TEAE), eventi avversi seri (SAE) ed eventi avversi di interesse speciale (AESI)
    17. Percentuale di soggetti con AE, TEAE, SAE, AESI
    18. Variazione dei parametri vitali
    19. Variazione del peso corporeo
    20. Variazione dell’elettrocardiogramma (ECG)
    21. Variazione dei test di funzionalità polmonare (PFT)
    22. Livelli sierici di IgG minimi al basale e prima della prima infusione
    23. Percentuale di responder (ACR CRISS > 0,6)
    24. Variazione media dal basale del mRSS
    25. Variazione media dal basale del HAQ-DI
    26. Variazione media dal basale della % prevista di capacità vitale forzata (FVC)
    27. Variazione media dal basale della MDGA
    28. Variazione media dal basale della PGA
    29. Numero di soggetti con eventi avversi (AE) tra cui qualsiasi AE, eventi avversi emergenti dal trattamento (TEAE), eventi avversi seri (SAE) ed eventi avversi di interesse speciale (AESI)
    30. Percentuale di soggetti con AE, TEAE, SAE, AESI
    31. Variazione dei parametri vitali
    32. Variazione dell’elettrocardiogramma (ECG)
    33. Variazione di FVC e DLCO
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. over 48 weeks
    2. over 48 weeks
    3. over 48 weeks
    4. over 48 weeks
    5. over 48 weeks
    6. over 48 weeks
    7. over 48 weeks
    8. over 48 weeks
    9. up to 48 weeks
    10. up to 48 weeks
    11. over 48 weeks
    12. over 48 weeks
    13. over 48 weeks
    14. over 48 weeks
    15. over 48 weeks
    16. over 48 weeks
    17. over 48 weeks
    18. over 48 weeks
    19. over 48 weeks
    20. over 48 weeks
    21. over 48 weeks
    22. At baseline and up to Weeks 24, 48, 60 and 72.
    23. over 72 weeks
    24. over 72 weeks
    25. over 72 weeks
    26. over 72 weeks
    27. over 72 weeks
    28. over 72 weeks
    29. over 72 weeks
    30. over 72 weeks
    31. over 72 weeks
    32. over 72 weeks
    33. over 72 weeks
    1. oltre 48 settimane
    2. oltre 48 settimane
    3. oltre 48 settimane
    4. oltre 48 settimane
    5. oltre 48 settimane
    6. oltre 48 settimane
    7. oltre 48 settimane
    8. oltre 48 settimane
    9. fino a 48 settimane
    10. fino a 48 settimane
    11. oltre 48 settimane
    12. oltre 48 settimane
    13. oltre 48 settimane
    14. oltre 48 settimane
    15. oltre 48 settimane
    16. oltre 48 settimane
    17. oltre 48 settimane
    18. oltre 48 settimane
    19. oltre 48 settimane
    20. oltre 48 settimane
    21. oltre 48 settimane
    22. Al basale e fino alle settimane 24, 48, 60 e 72.
    23. oltre 72 settimane
    24. oltre 72 settimane
    25. oltre 72 settimane
    26. oltre 72 settimane
    27. oltre 72 settimane
    28. oltre 72 settimane
    29. oltre 72 settimane
    30. oltre 72 settimane
    31. oltre 72 settimane
    32. oltre 72 settimane
    33. oltre 72 settimane
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Canada
    Mexico
    United States
    Belgium
    France
    Germany
    Italy
    Poland
    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
    The end of the clinical study for DB and OL treatment periods (ie, completion of the study at all participating study sites) is defined as the date of the final completing follow-up phone call (Follow-up Period).
    La conclusione dello studio clinico per i periodi di trattamento in doppio cieco e in aperto (ovvero il completamento dello studio presso tutti i centri dello studio partecipanti) è definita come la data dell’ultimo contatto telefonico di follow-up (periodo di follow-up).
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 144
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 81
    F.4.2.2In the whole clinical trial 144
    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 Decision2019-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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