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    Summary
    EudraCT Number:2016-000624-25
    Sponsor's Protocol Code Number:ATYR1940-C-006
    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:2021-01-19
    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 number2016-000624-25
    A.3Full title of the trial
    An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Biological Activity of ATYR1940 in Patients with Limb Girdle and Fascioscapulohumeral Muscular Dystrophy
    Studio di estensione in aperto per la valutazione a lungo termine di sicurezza, tollerabilit¿, e attivit¿ biologica di ATYR1940 in pazienti affetti da distrofie muscolari dei cingoli e facio-scapolo-omerale
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Study to Evaluate the Long-Term Safety, Tolerability, and Biological Activity of ATYR1940 in Patients with Limb Girdle and Fascioscapulohumeral Muscular Dystrophy
    Uno studio per valutare a lungo termine la sicurezza, la
    tollerabilit¿, e l¿attivit¿ biologica di ATYR1940 in pazienti affetti da distrofie muscolari dei cingoli e facio-scapolo-omerale
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberATYR1940-C-006
    A.5.4Other Identifiers
    Name:IND numberNumber:122045
    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 SponsorATYR PHARMA, 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 supportATYR PHARMA, INC.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVoisin Consulting
    B.5.2Functional name of contact pointClinical Trial Operations
    B.5.3 Address:
    B.5.3.1Street Address3 rue des Longs Pr¿s
    B.5.3.2Town/ cityBoulogne-Billancourt
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    B.5.4Telephone number0033 1 41 31 83 00
    B.5.5Fax number0033 1 41 31 83 09
    B.5.6E-mailclinicaltrialinformation@voisinconsulting.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 numberEU/3/15/1448
    D.3 Description of the IMP
    D.3.1Product nameATYR1940
    D.3.2Product code ATYR1940
    D.3.4Pharmaceutical form Concentrate for 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.3.9.2Current sponsor codeATYR1940
    D.3.9.4EV Substance CodeSUB129952
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Limb Girdle Muscular Dystrophy and Facioscapulohumeral Muscular Dystrophy
    distrofie muscolari dei cingoli e facio-scapolo-omerale
    E.1.1.1Medical condition in easily understood language
    Genetic myopathies
    distrofie muscolari genetiche
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10064087
    E.1.2Term Facioscapulohumeral muscular dystrophy
    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
    To evaluate the safety, tolerability, and immunogenicity of long-term treatment with intravenous (IV) ATYR1940 in patients with limb girdle muscular dystrophy 2B (LGMD2B) or fascioscapulohumeral muscular dystrophy (FSHD) previously enrolled in clinical study ATYR1940-C-003 (Stage 1 only) or ATYR1940-C-004.
    Valutare la sicurezza, tollerabilit¿ ed immunogenicit¿ a lungo termine di ATYR1940 somministrato per via endovenosa (EV) in pazienti affetti da distrofia muscolare dei cingoli 2B (LGMD2B) o distrofia muscolare facio-scapolo-omerale (FSHD) che abbiano partecipato in precedenza allo studio clinico ATYR1940-C-003 (solo Fase 1) o ATYR1940-C-004.
    E.2.2Secondary objectives of the trial
    To explore the biological and pharmacodynamic (PD) activity of ATYR1940 in patients with LGMD2B and FSHD, based on changes in:
    ¿ Serum-based muscle biomarkers.
    ¿ Inflammatory immune state in peripheral blood.
    ¿ Muscle disease and muscle disease burden, based on skeletal muscle MRI.
    ¿ Skeletal muscle strength.
    ¿ Upper and lower extremity muscle function.
    ¿ Quality of life measures.
    Indagare l'attivit¿ biologica e farmacodinamica (PD) di ATYR 1940 in pazienti affetti da LGMD2B e FSHD, in base alle variazioni di:
    ¿ Biomarker muscolari sierici.
    ¿ Stato immunologico infiammatorio nel sangue periferico.
    ¿ Patologia muscolare e impatto della patologia muscolare, valutati tramite risonanza magnetica nucleare (RMN).
    ¿ Forza dei muscoli scheletrici.
    ¿ Funzionalit¿ muscolare degli arti superiori ed inferiori.
    ¿ Misure della qualit¿ di vita.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Enrolled in and completed the treatment period in the parent study.
    2. Demonstrated, in the Investigator’s opinion, acceptable tolerability of ATYR1940.
    3. In the Investigator’s opinion, patient has shown acceptable compliance with ATYR1940 and the study procedures in the parent study and is willing and able to comply with all procedures in the current study.
    4. Is, in the Investigator’s and Sponsor’s opinion, a suitable candidate for continued ATYR1940 treatment.
    5. Provide written informed consent after the nature of the study has been explained and prior to the performance of any research-related procedures.
    1. Ha partecipato allo studio precedente e completato il periodo di trattamento.
    2. Ha dimostrato, a giudizio dello sperimentatore, una tolleranza accettabile ad ATYR1940.
    3. A giudizio dello sperimentatore, il paziente ha dimostrato sufficiente affidabilità nell'assumere ATYR1940 e nel seguire le procedure dello studio precedente, ed ha espresso la volontà e la capacità di attenersi a tutte le procedure del presente studio.
    4. È, a giudizio dello sperimentatore e del promotore, un candidato idoneo per quanto riguarda la continuazione del trattamento con ATYR1940.
    5. Fornisce il proprio consenso o assenso informato (come indicato, a seconda dello stato di maggiore età) dopo aver ricevuto spiegazion sulla natura dello studio e prima che sia effettuata qualsiasi procedura a scopo di ricerca.
    E.4Principal exclusion criteria
    1. At any time during participation in the parent study, met a ATYR1940 discontinuation criterion, including, but not limited to:
    - Jo-1 antibody (Ab) levels =1.5 U/mL.
    - Clinical evidence of a generalized infusion-related reaction (IRR).
    - Clinical evidence of a National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.03) =Grade 2, study-drug-related serious adverse event (SAE).
    - Pregnancy.
    - Progression of disease that, in the opinion of the Investigator, precluded further participation in the study.
    - Withdrawal of consent.
    - Other findings that, at the discretion of the Investigator and/or Sponsor, indicated that study drug administration should be discontinued.
    2. Is expected to require treatment with curcumin or systemic albuterol (intermittent inhaled albuterol is permissible) during study participation; or use of a product that putatively enhances muscle growth (e.g., insulin-like growth factor, growth hormone) or activity (e.g., Coenzyme Q, Coenzyme A, creatine, L-carnitine) on a chronic basis; or statin treatment initiation or significant adjustment to statin regimen (stable, chronic statin use is permissible).
    3. Patient planned to receive any vaccination during study participation.
    4. Abnormal baseline findings, medical condition(s), or laboratory findings that, in the Investigator’s opinion, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
    5. Evidence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, metabolic, dermatological, or gastrointestinal disease, or has a condition that requires immediate surgical intervention or other treatment or may not allow safe participation.
    6. If female and of childbearing potential (premenopausal and not surgically sterile), has a positive pregnancy test at entry or is unwilling to use contraception from the time of entry through the 3-month Follow-up visit. Acceptable methods of birth control include abstinence, barrier methods, hormones, or intra-uterine device.
    7. If male, is unwilling to use a condom plus spermicide during sexual intercourse from the time of entry through the 1 month Follow-up visit.
    1. In qualsiasi momento durante la partecipazione allo studio precedente, hanno soddisfatto uno dei criteri di interruzione, compresi ma non solo:
    - Valori degli anticorpi (Ab) Jo-1 =1.5 U/mL.
    - Segni clinici di reazione generalizzata all'infusione.
    - Evidenza di un evento avverso grave (SAE) collegato al farmaco di grado =2, secondo la National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (versione 4.03).
    - Gravidanza.
    - Progressione della patologia che, a giudizio dello sperimentatore, preclude ogni ulteriore partecipazione allo studio.
    - Ritiro del consenso o assenso.
    - Altre evidenze che, a giudizio dello sperimentatore e/o del Promotore, indicano che l'uso del farmaco sperimentale debba essere interrotto.
    2. Previsione di trattamento con curcumina o albuterolo sintetico (l'albuterolo per inalazione intermittente è consentito) durante la partecipazione allo studio; oppure uso di un prodotto ritenuto promotore della crescita (ad es. fattore di crescita insulino-simile, ormone della crescita) o dell'attività muscolare (ad es. Coenzima Q, Coenzima A, creatina, L-carnitina) su base cronica; oppure avvio del trattamento con statine o correzione sostanziale del regime di somministrazione delle statine (l'uso continuativo e stabile di statine è consentito).
    3. Intenzione di sottoporsi a vaccinazione durante la partecipazione allo studio.
    4. Riscontri anomali in condizioni di baseline, patologie o esami di laboratorio che, a giudizio dello sperimentatore, potrebbero mettere a rischio la sicurezza del paziente o ridurre la probabilità di ottenere dati adeguati per perseguire gli obiettivi dello studio.
    5. Evidenza di patologia significativa cardiovascolare, polmonare, epatica, renale, ematologica, metabolica, dermatologica o gastrointestinale, o patologia che necessita di immediato intervento chirurgico o altro trattamento o che potrebbe mettere a rischio la partecipazione del paziente.
    6. Se di sesso femminile ed in età fertile (pre-menopausa e non chirurgicamente sterile), esito positivo nel test di gravidanza di ingresso, o rifiuto di utilizzare contraccettivi dal momento dell'ingresso nello studio fino alla visita di follow-up a 3 mesi. I metodi contraccettivi accettabili comprendono l'astinenza, i metodi a barriera, ormoni e dispositivi intrauterini.
    7. Se di sesso maschile, rifiuta di utilizzare una combinazione di preservativo e spermicida durante il rapporto sessuale dal momento dell'ingresso nello studio fino alla visita di follow-up a 1 mese.
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability:
    • Incidence of treatment-emergent adverse events (TEAEs) and SAEs overall and by intensity
    • Changes from baseline in:
    - Safety laboratory test results
    - Electrocardiogram (ECG) findings
    - Vital signs measurements
    - Pulmonary evaluations (pulmonary function tests [PFTs] and pulse oximetry)
    - Incidence and level of anti-drug antibodies (ADA) titers and Jo-1 Ab levels
    • Exploratory characterization of immune response to ATYR1940
    Sicurezza e tollerabilità:
    • Incidenza totale e per gravità di eventi avversi dovuti al trattamento (TEAEs) ed eventi avversi gravi (SAEs).
    • Variazione rispetto alla baseline in:
    - Risultati degli esami di laboratorio in materia di sicurezza.
    - Riscontri elettrocardiografici (ECG).
    - Misurazioni dei segni vitali.
    - Esami polmonari (test di funzionalità polmonare [PFTs] e pulsossimetria).
    - Incidenza e valori del titolo degli anticorpi anti farmaco (ADA) e valori degli anticorpi Jo-1.
    • Caratterizzazione esplorativa della reazione immunitaria ad ATYR 1940.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety and tolerability:
    - Adverse events & vital signs & pulse oximetry & Jo-1 Ab: at week 1, every week and at 1, 4 and 12-week follow-up
    - Lab test results & ADA: at week 1, every month and at 1, 4 and 12-week follow-up
    - ECG: at week 1, every month and at 1 and 4-week follow-up
    - Pulmonary function tests: at week 1, every 6 weeks or every 3 months and at 4-week follow-up
    Sicurezza e tollerabilità:
    - Eventi avversi & segni vitali & pulsossimetria & anticorpi Jo-1: a settimana 1, ogni settimana e a 1, 4 e 12 settimane di follow-up
    - Esami di laboratorio & ADA: a settimana 1, ogni mese e a 1, 4 e 12 settimane di follow-up
    - ECG: a settimana 1, ogni mese e a 1 e 4 settimane di follow-up
    - Test di funzionalità polmonare: a settimana 1, ogni 6 settimane o ogni 3 mesi e a 4 settimane di follow-up
    E.5.2Secondary end point(s)
    Muscle strength and function:
    ¿ Changes from baseline in the following clinical parameters:
    - Muscle disease burden on lower extremity skeletal muscle MRI
    - Muscle strength, based on manual muscle testing (MMT)
    - Upper and lower extremity muscle function, based on the Brooke and Vignos scales, respectively

    Pharmacodynamics (exploratory):
    ¿ Changes in muscular-dystrophy-related inflammatory immune state in peripheral blood, as assessed by:
    - Circulating immune proteins, such as cytokines
    - Ex vivo inflammatory immune protein (including cytokines) release from peripheral blood mononuclear cells (PBMCs)
    - Immunophenotyping of circulating PBMCs
    ¿ Changes in serum- and/or plasma-based muscle biomarkers

    Quality of life (exploratory):
    ¿ INQoL questionnaire
    ¿ For patients with FSHD, the FSHD-specific Health Inventory (FSHD-HI) questionnaire

    Systemic exposure:
    ¿ Sparse pharmacokinetic (PK) sampling
    Effetti sulla muscolatura:
    ¿ Variazioni rispetto alla baseline nei seguenti parametri clinici:
    - Impatto della patologia muscolare sulla RMN dei muscoli degli arti inferiori.
    - Forza dei muscoli, misurata tramite test muscolare manuale (MMT).
    - Funzionalit¿ dei muscoli degli arti superiori ed inferiori, basata sulle scale di Brooke e Vignos, rispettivamente.

    Farmacodinamica (Esplorativa):
    ¿ Variazioni nello stato infiammatorio del sangue periferico collegato alla distrofia muscolare, valutato come segue:
    - Proteine immunitarie circolanti, ad es. citochine.
    - Rilascio ex-vivo di proteine immunitarie infiammatorie (comprese le citochine) da cellule mononucleari del sangue periferico (PBMCs).
    - Immunofenotipizzazione delle PBMC circolanti.
    ¿ Variazioni dei biomarker muscolari nel siero e/o nel plasma.

    Qualit¿ di vita (esplorativa):
    ¿ Individualized Neuromuscular Quality of Life (INQoL)
    ¿ Per i pazienti affetti da FSHD, con il questionario the FSHD-specific Health Inventory (FSHD-HI)

    Esposizione sistemica:
    ¿ Campionamento farmacocinetico (PK) sparso
    E.5.2.1Timepoint(s) of evaluation of this end point
    Muscle strength and function:
    - Surveillance skeletal muscle MRI: at week 1, every 3 months and at 12-week follow-up
    - MMT & Upper and lower extremity muscle function: at week 1, every 3 months and at 1-week follow-up

    Pharmacodynamics:
    - PBMCs & muscle biomarkers: at week 1, every 3 months and at 1 and 4-week follow-up

    Quality of life:
    - INQoL & FSHD-HI: at week 1, every 3 months and at 1 and 12-week follow-up

    Systemic exposure:
    - Serum ATYR1940 concentrations: at week 1, every 6 weeks and at 1-week follow-up
    Effetti sulla muscolatura:
    - RMN di sorveglianza dei muscoli scheletrici: a settimana 1, ogni 3 mesi e a 12 settimane di follow-up
    - Test muscolare manuale & funzionalit¿ degli arti superiori ed inferiori: a settimana 1, ogni 3 mesi e a 1 settimana di follow-up

    Farmacodinamica:
    - PBMC & biomarker muscolari: a settimana 1, ogni 3 mesi e a 1 e 4 settimane di follow-up

    Qualit¿ di vita:
    - INQoL & FSHD-HI: a settimana 1, ogni 3 mesi e a 1 e 12 settimane di follow-up

    Esposizione sistemica:
    - Concentrazioni sieriche di ATYR1940: a settimana 1, ogni 6 settimane e a 1 settimana di follow-up
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilit¿
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase 1b/2a: Long-Term Safety, Tolerability, and Biological Activity
    Fase 1b/2a: sicurezza, tollerabilit¿, e attivit¿ biologica a lungo termine
    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 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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    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. The 12-week follow-up visit is the End-of-Study visit.
    LVLS. La visita a 12 settimane di follow-up ¿ la visita di fine studio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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) No
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 4
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 8
    F.4.2.2In the whole clinical trial 24
    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)
    Subjects will return to their standard of care treatment as determined by their physician after completion of the trial.
    I soggetti torneranno al loro trattamento di cura abituale, come stabilito dal medico, dopo il completamento della sperimentazione.
    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 Decision2016-05-25
    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 StatusPrematurely Ended
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