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    Summary
    EudraCT Number:2019-004476-19
    Sponsor's Protocol Code Number:ACTIVE-BRIC2018–ID03
    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:2021-01-26
    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 number2019-004476-19
    A.3Full title of the trial
    Autologous mesenchymal stem/stromal Cells for the Treatment of workers affected by chronic low back pain due to multilevel InterVErtebral disc degeneration: a phase IIB randomized clinical trial - ACTIVE
    Cellule stromali/mesenchimali autologhe per il trattamento di lavoratori affetti da lombalgia cronica a causa della degenerazione del disco intervertebrale multilivello: trial clinico randomizzato di fase IIB - Studio ACTIVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of intradiscal injection of cells from the bone marrow in subjects with chronic back pain, caused by a degenerative disease affecting the vertebral disc, which does not respond to traditional therapy.
    Efficacia dell'iniezione intradiscale di cellule provenienti dal midollo osseo in soggetti con mal di schiena cronico, causato da una malattia degenerativa che colpisce il disco vertebrale, che non risponde alla terapia tradizionale.
    A.3.2Name or abbreviated title of the trial where available
    ACTIVE
    ACTIVE
    A.4.1Sponsor's protocol code numberACTIVE-BRIC2018–ID03
    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 SponsorUNIVERSITÀ CAMPUS BIO-MEDICO DI ROMA
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportINAIL - Bando Ricerca Finalizzata
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione GIMEMA
    B.5.2Functional name of contact pointCentro Dati GIMEMA
    B.5.3 Address:
    B.5.3.1Street Addressvia Casilina, 5
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00182
    B.5.3.4CountryItaly
    B.5.4Telephone number0670390526
    B.5.5Fax number0670390540
    B.5.6E-mailgimema@gimema.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCellule staminali mesenchimali/stromali autologhe isolate da midollo osseo
    D.3.2Product code [auto BM-MSC]
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradiscal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCellule staminali mesenchimali/ stromali autologhe estratte da midollo osseo
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Yes
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Symptomatic chronic low back pain due to a degenerative disease of the intervertebral disc
    Lombalgia cronica sintomatica dovuta a malattia degenerativa del disco intervertebrale
    E.1.1.1Medical condition in easily understood language
    Low back pain is the chronic pain of the lower back and is caused by the constant deterioration of the area between the two discs of the spine.
    La Lombalgia è il dolore cronico della parte bassa della schiena ed è causata dal costante deterioramento della zona presente tra i due dischi della colonna vertebrale.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10070241
    E.1.2Term Degenerative disc disease
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the efficacy of intradiscal injection of autologous BM-MSCs in workers affected by chronic LBP, due to multilevel (max. 4 levels) lumbar IDD after 12 months of treatment in terms of pain relief (VAS), functionality (ODI), quality of life (SF36) and work ability index (WAI).
    Valutare l’efficacia dell’iniezione intradiscale di BM-MSCs autologhe in lavoratori affetti da lombalgia cronica causata da IDD lombare multilivello (massimo 4 livelli) dopo 12 mesi di trattamento in termini di miglioramento del dolore (VAS), funzionalità (ODI), qualità della vita (SF36) e indice di abilità lavorativa (WAI).
    E.2.2Secondary objectives of the trial
    1) Evaluate regenerative changes of the treated IVD assessed by MRI including assessment of chemical biomarkers for tissue degeneration through MRI spectroscopy
    2) Assess modification of employment and work status between baseline and months 12 and 24
    3) Assess safety and tolerability.
    4) Evaluate consumption of medications to relieve pain such as type and dose of analgesics.
    1) Valutare modificazioni rigenerative dei dischi trattati mediante RM, con l’analisi dei markers biochimici di degenerazione tissutale attraverso la spettroscopia RM.
    2) Valutare le variazioni circa l’occupazione e le condizioni lavorative dall’inizio dello studio e a 12 e 24 mesi.
    3) Valutare sicurezza e tollerabilità del trattamento
    4) Valutare il ricorso ad analgesici (principio attivo e dosaggio).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Workers ( it means subject has worked at least 2 months, even if not continuously, in the last 6 months)
    - Age between 18 and 65 years.
    - Signed informed consent.
    - Symptomatic chronic LBP due to moderate-severe IDD [modified Pfirrmann score 3-5 (Pfirrmann et al., 2001), Griffith score 4-8 (Griffith et al., 2007)] at max. 4 levels of the lumbar spine unresponsive to
    conservative treatment, physical and medical for at least 6 months. Physical treatment includes physiotherapy. Medical treatments include NSAIDs, paracetamol, opioids and myorelaxant.
    - Annulus fibrosus intact, demonstrated by MRI.
    - Pain baseline > 40 mm on VAS (0- 100).
    - NSAIDs washout of at least 2 days before screening.
    - Painkillers washout of at least 24 hours before screening.
    - For females of childbearing potential (see definitions in paragraph 6.5), a negative pregnancy test must be documented at Screening.
    - Men and women should use effective contraception during treatment and for at least 24 months after BM-MSC discontinuation. The complete list of contraceptive methods is described in the patient information sheet and in paragraph 6.5. As a precautionary measure, breast-feeding should be discontinued during treatment with BM-MSC and should not be restarted after discontinuation of BM-MSC.
    - Lavoratori (si intende che il soggetto ha lavorato per almeno 2 mesi, anche se non in maniera continuativa, negli ultimi 6 mesi)
    - Età tra 18 e 65 anni
    - Consenso informato firmato
    - Lombalgia cronica sintomatica dovuta a IDD di grado moderato-severo [score di Pfirrmann modificato 3-5 (Pfirrmann et al., 2001), score di Griffith 4-8 (Griffith et al., 2007)] che coinvolge massimo 4
    livelli della colonna vertebrale lombare non responsiva al trattamento conservativo, fisico e medico per almeno 6 mesi. Le terapie fisiche includono la fisioterapia. La terapia medica include FANS,
    paracetamolo, oppioidi e miorilassanti.
    - Annulus fibrosus intatto alla RM
    - Dolore alla zona lombare al baseline > 40 mm sulla scala VAS (0-100).
    - Sospensione di FANS da almeno 2 giorni prima dello screening.
    - Sospensione di analgesici almeno 24 ore prima dello screening.
    - Le donne in età fertile (si vedano le definizioni al paragrafo 6.5 del Protocollo) devono effettuare un test di gravidanza allo screening che deve risultare negativo.
    - Uomini e donne dovrebbero utilizzare metodi contraccettivi efficaci durante il trattamento e per almeno 24 mesi dopo l’interruzione del trattamento con BM-MSCs. La lista completa dei metodi contraccettivi è descritta nel foglio informativo del paziente e nel paragrafo 6.5. Come misura precauzionale, l’allattamento dovrebbe essere interrotto durante il periodo di trattamento con BM-MSCs e non dovrebbe essere ripreso dopo la sospensione delle iniezioni di BM-MSCs.
    E.4Principal exclusion criteria
    - Non-workers (it means that the person has worked less than 2 months, although not continuously, in the last 6 months)
    - Congenital or acquired diseases leading to spine deformations that may upset cell application (scoliosis, isthmus lesion, sacralization and hemisacralization, degenetative spondilolisthesis, previous fractures of the lumbar spine).
    - Spinal segmental instability assessed by dynamic X-Ray.
    - Symptomatic facet joints syndrome on MRI (facet joints iperintensity and ipertrophy evaluated at coronal T2 weighted MRI).
    - Prior to the screening visit, has received:
    .Oral corticosteroid therapy within the previous 3 months, OR
    .Intramuscular, intravenous or epidural corticosteroid therapy within the previous 3 months.
    - Spinal canal stenosis (Schizas score > B).
    - History of spinal infection.
    - Lumbar disc herniation and sciatica.
    - Endplate abnormality such as Schmorl’s Nodes.
    - Previous discal puncture or previous spine surgery.
    - IDD with Modic IIII changes on MRI images.
    - Patients not eligible to the intravertebral disc surgery.
    - Patients who have the risk to undergo a surgery in the next 6 months.
    - Patients with local infusion device/devices for corticosteroids.
    - Obesity with body mass index (BMI in Kg/size in m2) greater than 35 (obesity grade II).
    - Participation in another clinical trial or treatment with another investigational product within 30 days prior to inclusion in the study.
    - Abnormal blood tests: hepatic (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST] >1.5 × upper limit of normal [ULN]), renal, pancreatic or biliary disease, blood coagulation disorders, anemia or platelet count of <100 × 109/L.
    - Pregnant or lactating women, or premenopausal women not using an acceptable form of birth control, are ineligible for inclusion. Contraception will be maintained during treatment and until the end of relevant systemic exposure. Additional pregnancy testing will be performed at the end of relevant systemic exposure. The patients will be required to use contraception from initial treatment administration until 24 months after the last dose of study drug.
    - In each case of delayed menstrual period (over one month between menstruations) confirmation of absence of pregnancy is strongly recommended. The complete list of contraceptive methods is described in the patient information sheet and in paragraph 6.5.
    - Positive serology for following infection: Syphilis, HIV, Hepatitis B, or C.
    - Contraindication to MRI assessed by the investigator.
    - Intolerance or allergy to local anaesthesia.
    - Any history of Cancer or immunodeficiency disease.
    - Previous transplantation.
    - Non lavoratori (si intende che il soggetto abbia lavorato meno di 2 mesi, anche in maniera non continuativa, negli ultimi 6 mesi).
    - Patologie congenite o acquisite associate a deformità vertebrali che potrebbero ostacolare la terapia cellulare (scoliosi, lesioni istmiche, sacralizzazione ed emisacralizzazione, spondilolistesi degenerativa,precedenti fratture della colonna vertebrale lombare).
    - Instabilità vertebrale segmentale evidenziata alle RX in proiezioni dinamiche.
    - Sindrome faccettaria sintomatica alla RM (iperintensità e ipertrofia delle faccette articolari alla RM in sequenza T2 in proiezione coronale).
    - Pazienti che, prima della visita di screening, hanno assunto:
    . Terapia corticosteroidea orale nei tre mesi precedenti, O:
    .Terapia corticosteroidea intramuscolare, endovenosa o epidurale nei tre mesi precedenti.
    - Lombalgia cronica sintomatica dovuta a IDD di grado moderato-severo [score di Pfirrmann modificato 3-5 (Pfirrmann et al., 2001), score di Griffith 4-8 (Griffith et al., 2007)] che coinvolge 5 livelli della colonna vertebrale lombare
    - Stenosi del canale vertebrale (Schizas score > B).
    - Pregressa infezione vertebrale.
    - Ernia del disco lombare e sciatica.
    - Anomalie dei dischi terminali, come ernie di Schmorl.
    - Pregressa puntura discale o intervento di chirurgia vertebrale.
    - IDD con alterazioni tipo Modic III alla RM.
    - Pazienti non idonei alla chirurgia del disco intervertebrale.
    - Pazienti che presentano il rischio di incorrere in interventi chirurgici nei 6 mesi successi all’inclusione nello studio.
    - Pazienti con dispositivo/i per infusione locale di corticosteroidi.
    - Obesità con un indice di massa corporea (BMI in Kg/statura in m2) maggiore di > 35 (obesità di grado II).
    - Partecipazione ad un altro trial clinico o trattamento con altro prodotto sperimentale nei 30 giorni precedenti all’inclusione nello studio.
    - Alterazione degli esami ematici: funzionalità epatica (alanina aminotrasferasi [ALT] e/o aspartato aminotrasferasi [AST] >1.5 oltre il valore limite normale [ULN]), funzionalità renale, pancreatica o biliare, alterazione del profilo emocoagulativo, anemia o conta piastrinica <100 × 109/L.
    - Donne in gravidanza o allattamento, o donne in pre-menopausa che non adottano un metodo contraccettivo adeguato non possono essere incluse. La contraccezione dovrà essere mantenuta durante il trattamento e fino al termine dello studio. Un test di gravidanza aggiuntivo sarà effettuato al termine dello studio. Ai pazienti è richiesto l’uso di metodi contraccettivi dall’inizio del trattamento e fino a 24 mesi dopo l’ultima dose del medicinale sperimentale.
    - In ogni caso di ritardo del periodo mestruale (oltre un intervallo di un mese tra le due mestruazioni), è fortemente raccomandato escludere la possibilità di un’eventuale gravidanza. La lista completa dei metodi contraccettivi è descritta nel foglio informativo per il paziente e nel paragrafo 6.5.
    - Positività sierologica per le seguenti infezioni: Sifilide, HIV, Epatite B o C
    - Non idoneità all’esecuzione di RM
    - Intolleranza o allergia all’anestesia locale.
    - Pregressa neoplasia o immunodeficienza.
    - Pregresso trapianto d’organo.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy of intradiscal injection of autologous BM-MSCs in workers affected by chronic LBP, due to multilevel (max. 4 levels) lumbar IDD, in terms of in terms of pain relief (VAS), functionality (ODI), defining responders in case of at least 40% improvement in VAS or ODI at month 12 compared to baseline and in term of quality of life (SF36) and 10% improvement on work ability index (WAI) score at month 12 compared to baseline and sham control.
    Valutare l'efficacia dell'iniezione intradiscale di cellule BM-MSC autologhe in lavoratori affetti da lombalgia cronica causata da IDD lombare multilivello (massimo 4 livelli) in termini di miglioramento del dolore (VAS), funzionalità (ODI), definendo responsivi i pazienti che presentano un miglioramento di almeno il 40% in VAS o ODI al mese 12 rispetto al basale, in termini di qualità della vita (SF36) e di aumento del 10% nel punteggio dell'Indice di Abilità Lavorativa (WAI) al mese 12 rispetto al baseline e al gruppo di controllo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 12 months from the treatment.
    Dopo 12 mesi dal trattamento.
    E.5.2Secondary end point(s)
    - To evaluate changes of the treated IVD induced by regenerative therapy by quantitative Magnetic Resonance Imaging (MRI) signal measurements in T2, T1spin/echo, T1 mapping and weighted images that allow a quantitative measure of the NP extracellular matrix and MRI spectroscopy that allow assessment of chemical biomarkers for tissue degeneration between baseline and 3, 6 and 12 months.
    - To evaluate modification of pain relief (VAS), disability (ODI), quality of life (SF-36) and work ability index (WAI) considered as continuos measures, between baseline and 1, 3, and 6 months.
    - Safety and tolerability will be evaluated by recording adverse events (AEs) and serious AEs (SAEs) throughout the study till 24 months. Number of participants with adverse events, the correlation of the AE to the IMP and their severity will be used as a measure of safety and tolerability.
    - To evaluate consumption of medications to relieve pain such as type and dose of analgesics will be evaluated. Paracetamol (acetaminophen) and levels 2 analgesics will be assessed throughout the study at each visit.
    - Valutare i cambiamenti dell'IVD trattati indotti dalla terapia rigenerativa mediante misure di Imaging quantitative del segnale di Risonanza Magnetica (MRI) nelle immagini T2, T1 spin/echo e T1rho pesate che consentono una misura quantitativa della matrice extracellulare del Nucleo Polposo (NP) e e spettroscopia MRI che consentono la valutazione di biomarcatori chimici per la degenerazione dei tessuti tra il basale e 3, 6 e 12 mesi.
    - Valutare la modifica in termini di miglioramento del dolore (VAS), funzionalità (ODI), qualità della vita (SF36) e indice di abilità lavorativa (WAI) considerati come misure continue tra il basale ed i mesi 1, 3 e 6.
    - La sicurezza e la tollerabilità saranno valutate registrando eventi avversi (AE) e eventi avversi gravi (SAE) durante lo studio fino a 24 mesi. Il numero di partecipanti con eventi avversi, la correlazione dell'AE all'IMP e la loro gravità saranno usati come misura di sicurezza e tollerabilità.
    - Valutare il consumo di farmaci per alleviare il dolore come il tipo e la dose di analgesici. Paracetamolo (acetaminofene) e analgesici di livello 2 saranno valutati durante lo studio ad ogni visita.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Between baseline and 1,3,6, 12 and 24 months.
    Tra il basale ed i mesi 1, 3, 6, 12 e 24.
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Gruppo di controllo sottoposto a procedura "sham" con sola anestesia
    Control group with a sham procedure including local anesthesia
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Last visit last subject
    Ultima visita dell'ultimo paziente.
    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 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: 26
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state52
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 52
    F.4.2.2In the whole clinical trial 52
    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)
    Patients will continue to be followed according to the normal care activity provided by good clinical practice.
    I pazienti continueranno ad essere seguiti secondo la normale attività assistenziale prevista dalla buona pratica 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 Decision2020-04-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-17
    P. End of Trial
    P.End of Trial StatusOngoing
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