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    Summary
    EudraCT Number:2014-005355-83
    Sponsor's Protocol Code Number:PTC124-GD-021e-CF
    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:2015-08-26
    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 number2014-005355-83
    A.3Full title of the trial
    A Phase 3 extension Study of Ataluren (PTC124®) in Patients with
    Nonsense Mutation Cystic Fibrosis
    STUDIO DI ESTENSIONE DI FASE 3 CON ATALUREN (PTC124®) IN PAZIENTI CON FIBROSI CISTICA DA MUTAZIONI NON SENSO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Confirmatory extension study of ataluren (PTC124) in patients with Cystic Fibrosis
    STUDIO DI ESTENSIONE DI CONFERMA CON ATALUREN (PTC124) IN PAZIENTI CON FIBROSI CISTICA
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberPTC124-GD-021e-CF
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02456103
    A.5.4Other Identifiers
    Name:INDNumber:48,648
    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 SponsorPTC 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 supportPTC Therapeutics, 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 Prés
    B.5.3.2Town/ cityBoulogne-Billancourt
    B.5.3.3Post code92100
    B.5.3.4CountryFrance
    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/3/05/277
    D.3 Description of the IMP
    D.3.1Product nameataluren
    D.3.2Product code PTC124
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNataluren
    D.3.9.1CAS number 775304-57-9
    D.3.9.2Current sponsor codePTC124
    D.3.9.4EV Substance CodeSUB89249
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/277
    D.3 Description of the IMP
    D.3.1Product nameataluren
    D.3.2Product code PTC124
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNataluren
    D.3.9.1CAS number 775304-57-9
    D.3.9.2Current sponsor codePTC124
    D.3.9.4EV Substance CodeSUB89249
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/277
    D.3 Description of the IMP
    D.3.1Product nameataluren
    D.3.2Product code PTC124
    D.3.4Pharmaceutical form Powder for oral suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNataluren
    D.3.9.1CAS number 775304-57-9
    D.3.9.2Current sponsor codePTC124
    D.3.9.4EV Substance CodeSUB89249
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    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
    Nonsense Mutation Cystic Fibrosis
    E.1.1.1Medical condition in easily understood language
    Genetic disease characterized by difficult breathing. Other symptoms include dysfunction of the pancreas, liver, bile duct and intestine, as well as reduced fertility.
    Malattia genetica caratterizzata da difficoltà respiratorie. Altri sintomi sono: disfunzione del pancreas, del fegato, del dotto biliare e dell’intestino, nonché una fertilità ridotta.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10011762
    E.1.2Term Cystic fibrosis
    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 long-term safety of 10-, 10-, 20-mg/kg ataluren in patients with nonsense mutation cystic fibrosis (nmCF), who previously participated in pivotal study PTC124-GD-021-CF, as determined by adverse events and laboratory abnormalities.
    Valutare la sicurezza a lungo termine di ataluren 10 mg/kg, 10 mg/kg e 20 mg/kg in pazienti con fibrosi cistica da mutazione non senso (nmCF), che hanno partecipato in precedenza allo studio cardine PTC124-GD-021-CF, come stabilito in base a eventi avversi e anomalie dei valori di laboratorio.
    E.2.2Secondary objectives of the trial
    - To evaluate the long-term effect of ataluren on pulmonary function
    - To evaluate the long-term effect of ataluren on pulmonary exacerbation
    - To determine the long-term effect of ataluren on medical interventions
    - To evaluate the long-term effect of ataluren on HRQL
    - To evaluate the long-term effect of ataluren on general well-being
    - To assess long-term ataluren plasma exposure
    - Valutare l'effetto a lungo termine di ataluren sulla funzionalità polmonare
    - Valutare l'effetto a lungo termine di ataluren sull'esacerbazione polmonare
    - Valutare l'effetto a lungo termine di ataluren sugli interventi medici
    - Valutare l'effetto a lungo termine di ataluren sulla HRQL
    - Valutare l'effetto a lungo termine di ataluren sul benessere generale
    - Valutare l'esposizione plasmatica a lungo termine ad ataluren
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Completion of study treatment (placebo or active) in the previous Phase 3, double-blind study protocol (Protocol PTC124-GD-021-CF).
    2. Evidence of signed and dated informed consent/assent document(s) indicating that the patient (and/or his parent/legal guardian) has been informed of all pertinent aspects of the trial.
    3. In patients who are sexually active, willingness to abstain from sexual intercourse or employ a barrier or medical method of contraception during the study drug administration and 4-week follow-up period.
    4. Willingness and ability to comply with scheduled visits, ataluren administration plan, study procedures, laboratory tests, and study restrictions
    1.Completamento del trattamento in studio (placebo o farmaco attivo) nel precedente protocollo di studio di fase 3, in doppio cieco (Protocollo PTC124-GD-021-CF).
    2.Evidenza di documento (i) di consenso/assenso informato firmato e datato, indicante(i) che il paziente (e/o il genitore/tutore legale del paziente) è stato informato riguardo a tutti gli aspetti pertinenti della sperimentazione.
    3.Nei pazienti sessualmente attivi, volontà di astenersi dai rapporti sessuali o di utilizzare un metodo contraccettivo di barriera o medico durante il periodo di somministrazione del farmaco in studio e per il periodo di follow-up di 4 settimane.
    4.Volontà e capacità di aderire alle visite programmate, al piano di somministrazione di ataluren, alle procedure dello studio, ai test di laboratorio e alle restrizioni dello studio.
    E.4Principal exclusion criteria
    1. Known hypersensitivity to any of the ingredients or excipients of the study drug.
    2. Ongoing participation in any other therapeutic clinical trial.
    3. Prior or ongoing medical condition (eg, concomitant illness, psychiatric condition, behavioral disorder, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the patient, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
    1. Ipersensibilità nota a uno dei principi attivi o degli eccipienti del farmaco in studio (Litesse® UltraTM [polidestrosio raffinato], polietilenglicole 3350, Lutrol® micro F127 [poloxamer 407], mannitolo 25C, crospovidone XL10, idrossietilcellulosa, vaniglia, Cab-O-Sil® M5P [silice colloidale], magnesio stearato).
    2. Partecipazione in corso ad altre sperimentazioni cliniche terapeutiche.
    3. Condizione medica precedente o in corso (ad es. malattia concomitante, disturbo psichiatrico, disturbo del comportamento, alcolismo, abuso di droga), anamnesi, risultati di esame obiettivo, risultati di ECG o anomalie dei valori di laboratorio che, secondo il parere dello sperimentatore, potrebbero influire negativamente sulla sicurezza del paziente, rendono improbabile il completamento del ciclo di trattamento o del follow-up o potrebbero compromettere la valutazione dei risultati dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    Safety profile characterized by type, frequency, severity, timing, and relationship to ataluren of any adverse events (AEs) or laboratory abnormalities.
    Profilo di sicurezza caratterizzato in base a tipo, frequenza, gravità, tempistica e rapporto rispetto ad ataluren di eventuali eventi avversi o anomalie nei valori di laboratorio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    AEs assessment and documention at : Screening, Week 12, 24, 36, 48, 60, 72, 84, 96, 4-Week Post-Treatment.
    Reporting of AEs of concern at any time between visits.
    Valutazione e documentazione degli eventi avversi alle visite: screening, settimane 12, 24, 36, 48, 60, 72, 84, 96, 4 settimane post trattamento. Segnalazione di eventi avversi di interesse, in qualsiasi momento tra una visita e l’altra.
    E.5.2Secondary end point(s)
    1- Changes in FEV1, FVC, and FEF25-75 as assessed by spirometry
    2- Rate, incidence, and duration of pulmonary exacerbations (modified Fuchs criteria)
    3- Incidences, rates, and durations of interventions (eg, antibiotic use and hospitalization) and disruptions to daily living (eg, missed school or work) resulting from pulmonary symptoms
    4- Changes in CFQ-R domains
    5- Changes in body weight and BMI
    6- New Pseudomonas aeruginosa lung infection
    7- Pre-dose ataluren plasma concentrations prior to morning ataluren administration at each clinic visit as assessed by a validated bioanalytical method
    8- Change from baseline in other safety parameters (eg, vital signs)
    - Variazioni a livello di FEV1, FVC e FEF25-75 valutate mediante spirometria
    - Tasso, incidenza e durata delle esacerbazioni polmonari (criteri di Fuchs modificati)
    - Incidenza, tasso e durata degli interventi (ad es. uso di antibiotici e ricovero ospedaliero) e delle interruzioni delle attività quotidiane (ad es. assenza da scuola o da lavoro) come conseguenza di sintomi polmonari
    - Variazioni dei domini del CFQ-R
    - Variazioni di peso corporeo e BMI
    - Nuova infezione polmonare da Pseudomonas aeruginosa
    - Concentrazioni plasmatiche pre-dose di ataluren prima della somministrazione del mattino di ataluren a ogni visita in clinica, valutate attraverso un metodo bioanalitico convalidato
    - Variazione dal basale in altri parametri di sicurezza (ad es. funzioni vitali)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints #1, 5 and 8 :
    Screening, Week 12, 24, 36, 48, 60, 72, 84, 96, 4-Week Post-Treatment.

    Secondary endpoints #2, 3, 4, 6 and 7 :
    Screening, Week 12, 24, 36, 48, 60, 72, 84, 96
    End point secondario #1, 5, 8 : Screening, settimane 12, 24, 36, 48, 60, 72, 84, 96, 4 settimane post trattamento.

    End point secondario #2, 3, 4, 6 and 7 : Screening settimane 12, 24, 36, 48, 60, 72, 84, 96
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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 No
    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
    Belgium
    Brazil
    Bulgaria
    Canada
    France
    Germany
    Greece
    Israel
    Italy
    Netherlands
    Poland
    Spain
    United Kingdom
    United States
    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
    Last visit of the last patient
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 80
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 20
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 120
    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 state29
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 141
    F.4.2.2In the whole clinical trial 200
    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)
    This study may be further extended by amendment until either ataluren becomes commercially available or the clinical development of ataluren in nmCF is discontinued. Should the study treatment not be extended, the long term care of the participant will remain the responsibility of the primary treating physician.
    La durata dello studio può essere prolungata tramite emendamento fino a quando ataluren diventa disponibile in commercio, oppure lo sviluppo clinico di ataluren in nmCF viene interrotto.
    In caso di mancato prolungamento, il trattamento a lungo termine del partecipante rientra nelle responsabilità del medico di base.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation CFFT TDN
    G.4.3.4Network Country United States
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation ECFS CTN
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-10-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-03-02
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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