Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-001255-36
    Sponsor's Protocol Code Number:GS-US-205-0162
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-09-28
    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 number2011-001255-36
    A.3Full title of the trial
    Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients with Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas aeruginosa (PA) Aztreonam Lysine for Pseudomonas Infection Eradication (ALPINE)study
    Studio clinico di Fase 2 in aperto, volto alla valutazione della sicurezza e dell'efficacia di Aztreonam 75 mg polvere e solvente per soluzione per nebulizzatore / Aztreonam soluzione per inalazione (AZLI) in pazienti pediatrici con fibrosi cistica (FC) e coltura delle vie respiratorie inferiori positiva per Pseudomonas aeruginosa (PA) di nuovo esordio. Studio ALPINE - Aztreonam-lisina per eradicazione dell'infezione da pseudomonas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria
    Studio con Aztreonam per inalazione in bambini con fibrosi cistica e nuova infezione delle vie aeree causata dal batterio Pseudomonas aeruginosa
    A.3.2Name or abbreviated title of the trial where available
    ALPINE
    ALPINE
    A.4.1Sponsor's protocol code numberGS-US-205-0162
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/117/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGILEAD SCIENCES 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 supportGilead Sciences Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 1223 897496
    B.5.5Fax number+44 1223 897284
    B.5.6E-mailclinical.trials@gilead.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Cayston Aztreonam 75 mg powder and solvent for nebuliser solution
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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/3/04/204
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for nebuliser solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAZTREONAM
    D.3.9.1CAS number 78110-38-0
    D.3.9.2Current sponsor codeAZLI
    D.3.9.4EV Substance CodeSUB05664MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Yes
    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
    Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
    Fibrosi cistica e nuova esordio di coltura del tratto respiratorio inferiore positiva per Pseudomonas aeruginosa
    E.1.1.1Medical condition in easily understood language
    Cystic fibrosis and a newly acquired lung infection with a bacterium (germ) called Pseudomonas aeruginosa
    Fibrosi cistica e recente comparsa di infezione polmonare causata da un batterio (germe) chiamato Pseudomonas aeruginosa
    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 15.0
    E.1.2Level PT
    E.1.2Classification code 10056971
    E.1.2Term Infective exacerbation of chronic obstructive airways disease
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level SOC
    E.1.2Classification code 10021881
    E.1.2Term Infections and infestations
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 safety and efficacy of a 28-day course of AZLI in patients with initial PA pulmonary colonization/infection at Day 28 (end of treatment) and Days 56, 112, and 196 (1, 3, and 6 months after the end of treatment, respectively).
    Valutare la sicurezza e l’efficacia di un ciclo di 28 giorni con AZLI in pazienti affetti da colonizzazione/infezione iniziale da PA al giorno 28 (fine del trattamento) e nei giorni 56, 112 e 196 (rispettivamente 1, 3, e 6 mesi dopo la fine del trattamento).
    E.2.2Secondary objectives of the trial
    Below the age of 6 years pharmacokinetic data will be assessed.
    Sono stati valutati i dati farmacocinetici di pazienti sotto i 6 anni di età.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Aged 3 months to less than 18 years. • Diagnosis of CF as determined by the 1997 CF Consensus Conference criteria: sweat chloride level ≥ 60 mEq/L by quantitative pilocarpine iontophoresis; or a genotype with 2 identifiable mutations consistent with CF; or an abnormal nasal transepithelial potential difference (NPD), and 1 or more clinical features consistent with CF. • Documented new onset of positive lower respiratory tract culture for PA within 30 days of study entry (screening visit) defined as either first lifetime documented PA-positive culture, or PA recovered after at least a 2-year history of PA-negative respiratory cultures (at least 2 cultures per year) • FEV1 ≥ 80% predicted (for patients ≥ 6 years of age). • Clinically stable with no evidence of significant respiratory symptoms or, if obtained for clinical evaluation, no chest radiograph findings at screening that would require administration of IV antipseudomonal antibiotics, oxygen supplementation, or hospitalization.
    • Età compresa fra 3 mesi e meno di 18 anni. • Diagnosi di FC secondo quanto stabilito dai criteri della CF Consensus Conference del 1997: livello di cloruro nel sudore ≥ 60 mEq/L mediante ionoforesi quantitativa con pilocarpina; o un genotipo con 2 mutazioni identificabili compatibili con FC; o una differenza anomala del potenziale transepiteliale nasale (NPD), e 1 o più caratteristiche cliniche compatibili con FC. • Nuovo esordio documentato di coltura delle vie respiratorie inferiori positiva per PA entro 30 giorni dall’ingresso nello studio (visita di screening), definita come prima coltura documentata positiva per PA permanente, o PA recidivante dopo almeno un’anamnesi di 2 anni di colture del tratto respiratorio PA-negative (almeno 2 colture l’anno. • FEV1 ≥ 80% previsto (per pazienti ≥ 6 anni). • Stabilità clinica, senza alcuna evidenza di sintomi respiratori significativi o, in caso di valutazione clinica, assenza di risultanze dagli esami radiografici al torace, effettuati allo screening, che richiederebbero la somministrazione di antibiotici attivi contro pseudomonas somministrati per IV, erogazione supplementare di ossigeno, od ospedalizzazione.
    E.4Principal exclusion criteria
    • Use of IV or inhaled antipseudomonal antibiotics within 2 years of study entry (screening visit). • Use of oral antipseudomonal antibiotics within 30 days of study entry (screening visit). • History of hypersensitivity/adverse reaction to aztreonam, or beta-agonists. • Use of any investigational drug, or device within 28 days of study entry (screening visit). • Presence of a condition or abnormality that would compromise the patient’s safety or the quality of study data, in the opinion of the investigator.
    • Uso di antibiotici contro Pseudomonas somministrati per IV o per inalazione nei 2 anni antecedenti l’ingresso nello studio (visita di screening). • Uso di antibiotici contro pseudomonas somministrati per via orale nei 30 giorni antecedenti l’ingresso nello studio (visita di screening). • Anamnesi positiva per ipersensibilità/ reazione avversa ad aztreonam o a beta-agonisti. • Uso di qualsiasi farmaco o dispositivo sperimentale nei 28 giorni antecedenti l’ingresso nello studio (visita di screening). • Presenza di una condizione o anomalia che comprometterebbe la sicurezza del paziente o la qualità dei dati dello studio, secondo il parere dello sperimentatore.
    E.5 End points
    E.5.1Primary end point(s)
    The primary objective of this study is to evaluate the proportion of patients with PA-negative cultures at all time points during a 6-month monitoring period (through Day 196) after cessation of active treatment; microbiological cultures will be obtained at Baseline, Day 28 (end of treatment), Day 56 (1 month after completing AZLI), Day 112 (3 months after completing AZLI), and Day 196 (6 months after completing AZLI). PA-specific antibody titers will be obtained at Baseline, Day 28, and Day 196. Safety endpoints will include adverse events, airway reactivity (study drug-induced bronchspasm), vital signs, blood biochemistry and hematology.
    L’obiettivo primario del presente studio è volto alla valutazione della proporzione dei pazienti con colture PA-negative in tutte le fasi durante un periodo di monitoraggio di 6 mesi (fino al giorno 196), dopo la cessazione del trattamento con il principio attivo; le colture microbiologiche saranno prelevate al basale, al giorno 28 (fine del trattamento), al giorno 56 (1 mese dopo l’ultimazione del trattamento con AZLI), al giorno 112 (3 mesi dopo l’ultimazione del trattamento con AZLI) e al giorno 196 (6 mesi dopo l’ultimazione del trattamento con AZLI). Saranno effettuati titoli anticorpali PA-specifici al basale, al giorno 28 e al giorno 196. Gli endpoint di sicurezza comprenderanno eventi avversi, reattività delle vie respiratorie (broncospasmo indotto dal farmaco in studio), segni vitali, parametri ematologici ed ematochimici.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Microbiological cultures will be obtained at Baseline (Day 1), Day 28 (end of treatment), Day 56 (1 month after completing AZLI), Day 112 (3 months after completing AZLI), and Day 196 (6 months after completing AZLI). PA-specific antibody titers will be obtained at Baseline, Day 28, and Day 196. Airway reactivity (study drug-induced bronchospasm) will be assessed at Baseline and Day 28. Blood biochemistry and hematology will be assessed at Screening, Baseline, Day 28 and Day 196. Adverse events and vital signs will be assessed at Screening, Baseline, Day 28, Day 56, Day 112 and Day 196.
    Le colture microbiologiche saranno prelevate al basale (Giorno 1), al giorno 28 (fine del trattamento), al giorno 56 (1 mese dopo l’ultimazione del trattamento con AZLI), al giorno 112 (3 mesi dopo l’ultimazione del trattamento con AZLI) e al giorno 196 (6 mesi dopo l’ultimazione del trattamento con AZLI). Saranno effettuati titoli anticorpali PA-specifici al basale, al giorno 28 e al giorno 196.
    E.5.2Secondary end point(s)
    In patients ≥ 6 years of age: • Change from baseline in FEV1 % predicted at Days 28, 56, 112, and 196; • Change from baseline in CFQ-R Respiratory Symptoms Score (RSS) at Days 28, 56, 112, and 196. In all patients: • Proportion of patients with PA-negative cultures at Days 28, 56, 112 and 196; • Use of additional (non-study) antipseudomonal antibiotics (as a marker for PA exacerbation); • Change from baseline in weight, height, and body mass index (BMI) at Days 28, 56, 112, and 196; In patients < 6 years of age: • Pharmacokinetics: 1 peak plasma sample will be obtained 1 hour after the first dose of AZLI (Day 1); 1 trough plasma sample will be obtained immediately prior to the last dose of AZLI (Day 28). Plasma aztreonam concentrations at each time point will be summarized (mean, median, standard deviation [SD], minimum, maximum, and number of samples).
    Gli obiettivi secondari sono volti alla valutazione di quanto segue: In pazienti ≥ 6 anni: • Variazione dal basale della % di FEV1 prevista ai giorni 28, 56, 112 e 196; • Variazione dal basale del punteggio RSS (Respiratory Symptoms Score) nel CFQ-R (Cystic Fibrosis Questionnaire-Revised) ai giorni 28, 56, 112 e 196; In tutti i pazienti: • Percentuale di pazienti con colture PA-negative ai giorni 28, 56, 112 e 196; • Uso di antibiotici supplementari (non in studio) contro pseudomonas (come marcatore per l’esacerbazione di PA); • Variazione dal basale di peso, altezza e indice di massa corporea (IMC) ai giorni 28, 56, 112 e 196; In pazienti < 6 anni: • Profilo farmacocinetico: 1 campione per i livelli plasmatici di picco sarà prelevato 1 ora dopo la prima dose di AZLI (giorno 1); 1 campione per i livelli plasmatici di valle sarà prelevato subito prima dell’ultima dose di AZLI (giorno 28). In ogni fase, saranno sintetizzate le concentrazioni plasmatiche di aztreonam (media, mediana, deviazione standard [DS], minimo, massimo e numero di campioni).
    E.5.2.1Timepoint(s) of evaluation of this end point
    In patients ≥ 6 years of age at Days 28, 56, 112, and 196: • Change from baseline in FEV1 % predicted; • Change from baseline in CFQ-R Respiratory Symptoms Score (RSS). In all patients at Days 28, 56, 112 and 196: • Proportion of patients with PA-negative cultures; • Change from baseline in weight, height, and body mass index (BMI). In all patients at Screening and Days 1, 28, 56, 112 and 196: • Use of additional (non-study) antipseudomonal antibiotics (as a marker for PA exacerbation). In patients < 6 years of age: • Pharmacokinetics: 1 peak plasma sample will be obtained 1 hour after the first dose of AZLI (Day 1); 1 trough plasma sample will be obtained immediately prior to the last dose of AZLI (Day 28).
    In pazienti ≥ 6 anni ai giorni 28, 56, 112 e 196: • Variazione dal basale della % di FEV1 • Variazione dal basale del punteggio RSS (Respiratory Symptoms Score) nel CFQ-R (Cystic Fibrosis Questionnaire-Revised); In tutti i pazienti ai giorni 28, 56, 112 e 196: • percentuale di pazienti con colture PA-negative • Uso di antibiotici supplementari (non in studio) contro pseudomonas (come marcatore per l’esacerbazione di PA); • Variazione dal basale di peso, altezza e indice di massa corporea (IMC); In pazienti < 6 anni: • Profilo farmacocinetico: 1 campione per i livelli plasmatici di picco sarà prelevato 1 ora dopo la prima dose di AZLI (giorno 1); 1 campione per i livelli plasmatici di valle sarà prelevato subito prima dell'ultima dose di AZLI (giorno 28).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA39
    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
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months20
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months20
    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.1.1Number 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) Yes
    F.1.1.4.1Number of subjects for this age range: 20
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) No
    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 No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infants and young children
    Lattanti e bambini piccoli
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adolescent girls of childbearing potential using contraception
    Ragazze adolescenti in età fertile che fanno uso di contraccettivi
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 60
    F.4.2.2In the whole clinical trial 80
    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)
    Upon completion of study participation, subjects will be referred back to the physician who referred them to the study for continuing care and treatment.
    Al termine della partecipazione allo studio i soggetti dovranno fare riferimento al medico per il proseguimento del trattamento.
    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 European Cystic Fibrosis Society Clinical Trials Network (ECFS-CTN)
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Cystic Fibrosis Foundation Therapeutics (CFFT) Therapeutics Development Network (TDN)
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-06-20
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Sat Apr 20 00:45:22 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA