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    Summary
    EudraCT Number:2017-003538-10
    Sponsor's Protocol Code Number:BIVV009-03
    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:2021-01-28
    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 number2017-003538-10
    A.3Full title of the trial
    A PHASE 3, PIVOTAL, OPEN-LABEL, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF BIVV009 IN PATIENTS WITH PRIMARY COLD
    AGGLUTININ DISEASE WHO HAVE A RECENT HISTORY OF BLOOD TRANSFUSION
    STUDIO DI FASE 3, PIVOTALE, IN APERTO, MULTICENTRICO PER VALUTARE L¿EFFICACIA E LA SICUREZZA DI BIVV009 IN PAZIENTI AFFETTI DA MALATTIA DA AGGLUTININE A FREDDO PRIMARIA CHE HANNO UN¿ANAMNESI RECENTE DI TRASFUSIONI DI SANGUE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open-Label with BIVV009 in patients with Cold Agglutinin Disease
    Studio in aperto con BIVV009 in pazienti affetti da Malattia da Agglutinine a Freddo
    A.3.2Name or abbreviated title of the trial where available
    Cardinal Study
    Cardinal Study
    A.4.1Sponsor's protocol code numberBIVV009-03
    A.5.4Other Identifiers
    Name:Cardinal StudyNumber:BIVV009-03
    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 SponsorBIOVERATIV THERAPEUTICS INC
    B.1.3.4CountryUnited States
    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 supportBioverativ USA Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharm-Olam, LLC
    B.5.2Functional name of contact pointClinical Trial Dept
    B.5.3 Address:
    B.5.3.1Street Address460 N. Sam Houston Parkway, E. Suit 250
    B.5.3.2Town/ cityHouston
    B.5.3.3Post codeTX 77060
    B.5.3.4CountryUnited States
    B.5.4Telephone number00171355979001133
    B.5.5Fax number00171355979001133
    B.5.6E-mailtracy.klenk@pharm-olam.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 numberEMA/OD/177/15
    D.3 Description of the IMP
    D.3.1Product nameBIVV009
    D.3.2Product code BIVV009
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIVV009
    D.3.9.2Current sponsor codeBIVV009
    D.3.9.3Other descriptive nameTNT009
    D.3.9.4EV Substance CodeSUB177476
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIVV009
    D.3.9.2Current sponsor codeBIVV009
    D.3.9.4EV Substance CodeSUB177476
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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) 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
    Primary Cold Agglutinin Disease
    MALATTIA DA AGGLUTININE A FREDDO PRIMARIA
    E.1.1.1Medical condition in easily understood language
    Autoimmune Disease against red blood cells (Haemolytic Anaemia)
    Malattia Autoimmune contro gli eritrociti (Anemia Emolitica)
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10073785
    E.1.2Term Autoimmune haemolytic anaemia
    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
    Part A:
    The primary objective of Part A is to determine whether BIVV009
    administration results in a = 2 g/dL increase in hemoglobin (Hgb) levels
    or increases Hgb to = 12 g/dL and obviates the need for blood
    transfusion during treatment in patients with primary CAgD who have a
    recent history of transfusion
    Part B:
    The primary objective of Part B is to evaluate the long-term safety and
    tolerability of BIVV009 in patients with primary CAgD.
    Parte A: L'obiettivo primario della parte A ¿ quello di determinare se la somministrazione di BIVV009 produce un aumento dei livelli di emoglobina (HGB) di = 2 g/dL o aumenta il livello di Hgb a = 12 g/dL e previene la necessit¿ di trasfusioni di sangue durante il trattamento in pazienti affetti da CAgD primaria che hanno un¿anamnesi recente di trasfusioni
    Parte B: L'obiettivo primario della Parte B ¿ valutare la sicurezza a lungo termine e la tollerabilit¿ di BIVV009 in pazienti affetti da CAgD primaria
    E.2.2Secondary objectives of the trial
    Part A:
    Efficacy:
    ¿To assess the effect of BIVV009 on clinical events and laboratory
    parameters related to hemolysis and anemia in patients with primary
    CAgD
    ¿To assess the effect of BIVV009 on quality of life (QOL) in patients with
    primary CAgD
    Safety:
    ¿To evaluate the overall safety and tolerability of BIVV009 in patients
    with primary CAgD
    Exploratory:
    ¿To assess the effect of BIVV009 on specific complications of CAgD
    ¿To evaluate the effect of BIVV009 on certain disease-related
    biomarkers in patients with primary CAgD
    ¿To evaluate the pharmacokinetics of BIVV009
    Part B:
    ¿The secondary objective of Part B is to investigate the durability of
    response during long-term treatment with BIVV009 in patients with
    primary CAgD.
    Parte A:
    Efficacia:
    ¿Valutare l'effetto di BIVV009 su eventi clinici e parametri di laboratorio correlati a emolisi e anemia in pazienti affetti da CAgD primaria
    ¿Valutare l'effetto di BIVV009 sulla qualit¿ della vita (QOL) in pazienti affetti da CAgD primaria
    Sicurezza:
    ¿Valutare la sicurezza globale e la tollerabilit¿ di BIVV009 in pazienti affetti da CAgD primaria
    Esplorativi:
    ¿Valutare l'effetto di BIVV009 su specifiche complicanze di CAgD
    ¿Valutare l'effetto di BIVV009 su alcuni biomarcatori correlati alla malattia in pazienti affetti da CAgD primaria
    ¿Valutare la farmacocinetica di BIVV009
    Parte B:
    ¿L'obiettivo secondario della parte B ¿ studiare la durata della risposta durante il trattamento a lungo termine con BIVV009 in pazienti affetti da CAgD primaria.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult males and females = 18 years of age at Screening
    2. Body weight of = 39 kg at Screening
    3. Confirmed diagnosis of primary CAgD based on the following criteria:
    a. Chronic hemolysis
    b. Polyspecific direct antiglobulin test (DAT) positive
    c. Monospecific DAT strongly positive for C3d
    d. Cold agglutinin titer = 64 at 4¿C
    e. IgG DAT = 1+, and
    f. No overt malignant disease
    4. History of at least one documented blood transfusion within 6 months of enrollment
    5. Hemoglobin level = 10.0 g/dL
    6. Bilirubin level above the normal reference range, including patients with Gilbert’s Syndrome
    7. Ferritin levels above the lower limit of normal. Concurrent treatment with iron supplementation is permitted if the patient has been on a stable dose during the previous 4 weeks.
    8. Presence of one or more of the following CAgD-related signs or symptoms within 3 months of Screening:
    a. Symptomatic anemia defined as:
    i. Fatigue
    ii. Weakness
    iii. Shortness of breath
    iv. Palpitations, fast heart beat
    v. Light headedness and/or
    vi. Chest pain
    b. Acrocyanosis
    c. Raynaud’s syndrome
    d. Hemoglobinuria
    e. Disabling circulatory symptoms, and/or
    f. Major adverse vascular event (including thrombosis)
    9. Bone marrow biopsy within 6 months of Screening with no overt evidence of lymphoproliferative disease or other hematological malignancy. An additional bone marrow biopsy will be required if the prior bone marrow is deemed unsuitable for analysis by the Sponsor.
    10. Documented vaccinations against encapsulated bacterial pathogens (Neisseria meningitis, including serogroup B meningococcus where available, Haemophilus influenzae, and Streptococcus pneumoniae) within 5 years of enrollment or as specified in Section 6.1.1.1.
    11. Adequate IV access
    12. If female, must be post-menopausal, surgically sterile, or be established on (= 3 months prior to Screening) and agree to continue to use the same highly effective methods of birth control throughout the study and for 9 weeks following administration of the last dose of study drug
    13. Males must be surgically sterile for at least 90 days or when sexually active with female partners of child-bearing potential will agree to use highly effective contraception from Day 0 until 9 weeks following administration of the last dose of study drug.
    14. Able to comprehend and give informed consent
    15. Able to comply with the requirements of the study and to complete the full sequence of protocol-related procedures
    1. Adulti di sesso maschile e femminile di età = 18 anni allo Screening
    2. Peso corporeo = 39 kg allo Screening
    3. Diagnosi confermata di CAgD primaria sulla base dei seguenti criteri:
    a. Emolisi cronica,
    b. Test dell’antiglobulina diretto (DAT) polispecifico positivo,
    c. DAT monospecifico fortemente positivo per C3d,
    d. Titolo delle agglutinine a freddo =64 a 4¿C,
    e. DAT IgG = 1+, e
    f. Nessuna evidenza di patologia maligna
    4. Anamnesi di almeno una trasfusione di sangue documentata entro 6 mesi dall’arruolamento
    5. Livello di emoglobina = 10,0 g/dL
    6. Livello di bilirubina al di sopra del normale intervallo di riferimento, compresi pazienti con la Sindrome di Gilbert
    7. Livelli di ferritina superiori al limite inferiore della norma. Il trattamento concomitante con supplemento di ferro è consentito se il paziente ha assunto una dose stabile durante le 4 settimane precedenti.
    8. Presenza di uno o più dei seguenti segni o sintomi correlati a CAgD entro 3 mesi dallo Screening:
    a. Anemia sintomatica definita come:
    i. affaticamento
    ii. debolezza
    iii. respiro affannoso
    iv. palpitazioni, battito cardiaco accelerato
    v. stordimento e/o
    vi. dolore al petto
    b. acrocianosi
    c. Sindrome di Raynaud
    d. Emoglobinuria
    e. Sintomi circolatori invalidanti, e/o
    f. Eventi avversi vascolari maggiori (compresa trombosi)
    9. Biopsia del midollo osseo entro 6 mesi dallo Screening e nessuna palese evidenza di malattia linfoproliferativa o altre neoplasie ematologiche. Se il precedente campione di midollo osseo viene ritenuto non idoneo per l'analisi da parte dello Sponsor, sarà necessario eseguire una biopsia del midollo osseo aggiuntiva.
    10. Documentate vaccinazioni contro patogeni batterici incapsulati (Neisseria meningitis compreso il sierogruppo meningococco B dove disponibile, Haemophilus influenzae e Streptococcus pneumoniae) entro 5 anni dall’arruolamento o come specificato nella Sezione 6.1.1.1.
    11. Accesso EV adeguato
    12. Se di sesso femminile, deve essere in post-menopausa, chirurgicamente sterile, o usare stabilmente (= 3 mesi prima dello Screening) e accettare di continuare a utilizzare lo stesso metodo contraccettivo altamente efficace durante tutto lo studio e per 9 settimane dopo la somministrazione dell'ultima dose di farmaco in studio
    13. Gli uomini devono essere chirurgicamente sterili da almeno 90 giorni o, se sessualmente attivi con partner di sesso femminile in età fertile, dovranno accettare di usare metodi di contraccezione altamente efficaci dal Giorno 0 fino a 9 settimane dopo la somministrazione dell'ultima dose di farmaco in studio.
    14. In grado di comprendere e dare il proprio consenso informato
    15. In grado di soddisfare le esigenze dello studio e di completare l’intera sequenza delle procedure correlate al protocollo
    E.4Principal exclusion criteria
    1. Cold agglutinin syndrome secondary to infection, rheumatologic disease, or active hematologic malignancy
    2. Clinically relevant infection of any kind within the month preceding enrollment (eg, active hepatitis C, pneumonia).
    3. Clinical diagnosis of systemic lupus erythematosus (SLE) or other autoimmune disorders with anti-nuclear antibodies at Screening. Anti-nuclear antibodies of long standing duration without associated clinical symptoms will be adjudicated on a case-by-case basis during the Confirmatory Review of Patient Eligibility (Section 6.1.1.3).
    4. Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C virus antibody) prior to or at Screening.
    5. Positive human immunodeficiency virus (HIV) antibody at Screening.
    6. Treatment with rituximab monotherapy within 3 months or rituximab combination therapies (eg, with bendamustine, fludarabine, ibrutinib, or cytotoxic drugs) within 6 months prior to enrollment.
    7. Concurrent treatment with corticosteroids other than a stable daily dose equivalent to = 10 mg/day prednisone for previous 3 months.
    8. Erythropoietin deficiency. Concurrent treatment with erythropoietin is permitted if the patient has been on a stable dose for the previous 3 months.
    9. Concurrent usage of iron supplementation unless the patient has been on a stable dose for at least 4 weeks.
    10. Clinically significant medical history or ongoing chronic illness that would jeopardize the safety of the patient or compromise the quality of the data derived from his/her participation in this study (as determined by the Investigator [or designee]) at Screening.
    11. Concurrent treatment with other experimental drugs or participation in another clinical trial with any investigational drug within 30 days or 5 half lives, whichever is greater, prior to treatment start.
    12. Females who are pregnant, lactating, or, if having reproductive potential, are considered potentially unreliable with respect to contraceptive practice.
    13. History of hypersensitivity to BIVV009 or any of its components.
    1. Sindrome da agglutinine a freddo secondaria a infezione, malattia reumatologica o neoplasia ematologica attiva
    2. Infezione clinicamente rilevante di qualsiasi genere entro il mese precedente l’arruolamento (ad es, epatite C attiva, polmonite).
    3. Diagnosi clinica di lupus eritematoso sistemico (SLE) o altre malattie autoimmuni con anticorpi anti-nucleo allo Screening. Gli anticorpi anti-nucleari di lunga durata senza la presenza di sintomi clinici associati, saranno valutati caso per caso durante la Confirmatory Review dell’Eleggibilità del Paziente (Sezione 6.1.1.3.).
    4. Quadro completo di analisi per l’epatite positivo (compresi antigene superficiale dell’epatite B e/o anticorpo del virus dell’epatite C) prima di o allo Screening
    5. Esito positivo per gli anticorpi del virus dell'immunodeficienza umana (HIV) allo Screening
    6. Trattamento con rituximab in monoterapia entro 3 mesi o in combinazione (ad es., con bendamustina, fludarabina, ibrutinib, o farmaci citotossici) entro 6 mesi prima dell'arruolamento
    7. Trattamento concomitante con corticosteroidi diverso da una dose giornaliera stabile equivalente a = 10 mg/die di prednisone per i 3 mesi precedenti
    8. Deficit di eritropoietina Il trattamento concomitante con eritropoietina è consentito se il/la paziente ha seguito una terapia con dosaggio stabile per i 3 mesi precedenti.
    9. Utilizzo concomitante di integratori di ferro a meno che il/la paziente non abbia seguito una terapia con dosaggio stabile da almeno 4 settimane.
    10. Anamnesi medica clinicamente significativa o malattia cronica in corso che metterebbe a rischio la sicurezza del/della paziente o comprometterebbe la qualità dei dati derivati dalla sua partecipazione a questo studio (come stabilito dallo sperimentatore [o da un suo incaricato]) allo Screening.
    11. Trattamento concomitante con altri farmaci sperimentali o partecipazione ad un altro studio clinico con qualsiasi farmaco sperimentale entro 30 giorni o 5 emivite, a seconda di quale dei due sia il periodo più lungo, prima di iniziare il trattamento
    12. Donne in gravidanza o allattamento o, se in età fertile, considerate potenzialmente inaffidabili rispetto alla pratica contraccettiva.
    13. Storia clinica di ipersensibilità a BIVV009 o a qualcuno dei suoi componenti.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the responder rate. A patient will be
    considered a responder if he or she did not receive a blood transfusion
    from Week 5 through Week 26 (EOT) and did not receive treatment for
    CAgD beyond what is permitted per protocol. Additionally, the patient's
    Hgb level must meet either of the following criteria:
    • Hgb level is = 12 g/dL at the treatment assessment endpoint (defined
    as mean value from Weeks 23, 25, and 26), or
    • Hgb increased = 2 g/dL from baseline (defined as the last Hgb value
    before administration of the first dose of study drug) at treatment assessment endpoint
    L'endpoint di efficacia primario è la percentuale di responder. Un paziente sarà considerato responder se lui o lei non ha ricevuto una trasfusione di sangue
    dalla Settimana 5 alla Settimana 26 (EOT) e non ha ricevuto il trattamento per CAgD al di là di quanto è consentito per protocollo. Inoltre, i livelli di Hgb del paziente devono soddisfare uno dei seguenti criteri:
    • Il livello Hgb è = 12 g / dL all'endpoint per la valutazione del trattamento (definito
    come valore medio dalle Settimane 23, 25 e 26), oppure
    • Hgb è aumentato di = 2 g / dL dal baseline (definito come ultimo valore Hgb
    prima della somministrazione della prima dose di farmaco in studio) all'endpoint per la valutazione del trattamento
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 26 (EOT)
    Settimana 26 (EOT)
    E.5.2Secondary end point(s)
    ¿Mean change from baseline in bilirubin (excluding patients with
    Gilbert's Syndrome) at the treatment assessment endpoint (mean of
    values at Week 23, 25, and 26)
    ¿Mean change from baseline in QOL, as assessed by the change in
    Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale
    scores at the treatment assessment endpoint
    ¿Mean change from baseline in lactate dehydrogenase (LDH) at the
    treatment assessment endpoint
    ¿Number of transfusions and number of units after the first 5 weeks of
    study drug administration
    ¿Mean change from baseline in Hgb at the treatment assessment endpoint
    ¿ Variazione media rispetto alla baseline di bilirubina (esclusi i pazienti con sindrome di Gilbert), all¿endpoint di valutazione del trattamento (media dei valori alle Settimane 23, 25 e 26)
    ¿ Variazione media rispetto alla baseline della QOL, valutata mediante la variazione dei punteggi sulla Scala di valutazione funzionale della fatica collegata alla terapia di una malattia cronica (Functional Assessment of Chronic Illness Therapy FACIT-Fatigue) all¿endpoint di valutazione del trattamento
    ¿ Variazione media rispetto alla baseline dei livelli di lattato deidrogenasi (LDH) all¿endpoint di valutazione del trattamento
    ¿ Numero di trasfusioni e numero di unit¿ dopo le prime 5 settimane di somministrazione del farmaco in studio
    ¿ Variazione media rispetto alla baseline di Hgb all¿endpoint di valutazione del trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 26 (EOT)
    Settimana 26 (EOT)
    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 Yes
    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) 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 No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA37
    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
    Austria
    Belgium
    Canada
    France
    Germany
    Israel
    Italy
    Japan
    Netherlands
    New Zealand
    Norway
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 14
    F.4.2.2In the whole clinical trial 20
    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
    Terapia standard
    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 Decision2018-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-09
    P. End of Trial
    P.End of Trial StatusOngoing
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