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    Summary
    EudraCT Number:2014-004788-18
    Sponsor's Protocol Code Number:VX14-661-108
    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:2015-03-19
    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 number2014-004788-18
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function
    Studio di fase 3, randomizzato, in doppio cieco, controllato con placebo, di cross-over, per valutare l’efficacia e la sicurezza di ivacaftor e VX-661 in associazione a ivacaftor in soggetti di età pari e superiore a 12 anni affetti da fibrosi cistica, eterozigoti per la mutazione F508del-CFTR e portatori di una mutazione CFTR sul secondo allele con prevista funzione residua
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor
    Studio in soggetti affetti da fibrosi cistica (una rara malattia polmonare ereditaria) per valutare l’efficacia e la sicurezza di due farmaci sperimentali: ivacaftor e VX 661 in combinazione con ivacaftor
    A.4.1Sponsor's protocol code numberVX14-661-108
    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 SponsorVertex Pharmaceuticals Incorporated
    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 supportVertex Pharmaceuticals Incorporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVertex Pharmaceuticals Incorporated
    B.5.2Functional name of contact pointClinical Trials and Medical Info
    B.5.3 Address:
    B.5.3.1Street Address50 Northern Avenue
    B.5.3.2Town/ cityBoston, MA
    B.5.3.3Post code02210
    B.5.3.4CountryUnited States
    B.5.4Telephone number001877634 8789
    B.5.5Fax number001510595 8183
    B.5.6E-mailmedicalinfo@vrtx.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/3/14/1281
    D.3 Description of the IMP
    D.3.1Product nameVX-661/ivacaftor 100mg/150 mg
    D.3.2Product code VX-661/VX-770
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNNot yet assigned
    D.3.9.1CAS number 1152311-62-0
    D.3.9.2Current sponsor codeVX-661
    D.3.9.3Other descriptive nameVRT-893661 VRT-0893661
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIVACAFTOR
    D.3.9.1CAS number 873054-44-5
    D.3.9.2Current sponsor codeVX-770
    D.3.9.4EV Substance CodeSUB33103
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    D.2.1.1.1Trade name Kalydeco
    D.2.1.1.2Name of the Marketing Authorisation holderVertex Pharmaceuticals (U.K.) Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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/3/08/556
    D.3 Description of the IMP
    D.3.1Product nameivacaftor
    D.3.2Product code VX-770, VRT-813077
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNIVACAFTOR
    D.3.9.1CAS number 873054-44-5
    D.3.9.2Current sponsor codeVX-770
    D.3.9.4EV Substance CodeSUB33103
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Cystic Fibrosis
    Fibrosi Cistica
    E.1.1.1Medical condition in easily understood language
    Cystic Fibrosis
    Fibrosi Cistica
    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 17.1
    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 efficacy of VX-661 in combination with ivacaftor and ivacaftor monotherapy through 8 weeks of treatment in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation on the CF transmembrane conductance regulator (CFTR) gene and a second allele with a CFTR mutation predicted to have residual function.
    Valutare l’efficacia di VX-661 in combinazione con ivacaftor e ivacaftor in monoterapia nel corso di 8 settimane di trattamento in soggetti affetti da fibrosi cistica (FC), eterozigoti per la mutazione F508del del gene regolatore della conduttanza transmembrana della FC (cystic fibrosis transmembrane conductance regulator, CFTR) e portatori di una mutazione CFTR sul secondo allele con prevista funzione residua.
    E.2.2Secondary objectives of the trial
    •To evaluate the safety of VX-661 in combination with ivacaftor through 8 weeks of treatment
    •To evaluate the safety of ivacaftor monotherapy through 8 weeks of treatment
    •To investigate the pharmacokinetics (PK) of VX-661 and its metabolite M1 (M1-661), and ivacaftor and its metabolite M1 (M1-ivacaftor)
    Valutare la sicurezza di VX-661 in combinazione con ivacaftor nel corso di 8 settimane di trattamento
    • Valutare la sicurezza di ivacaftor in monoterapia nel corso di 8 settimane di trattamento
    • Analizzare la farmacocinetica (pharmacokinetics, PK) di VX-661 e del suo metabolita, M1 (M1-661), e di ivacaftor e del suo metabolita, M1 (M1-ivacaftor)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subjects (males and females) will be aged 12 years or older on the date of informed consent or, where appropriate, assent.
    • Heterozygous for F508del-CFTR and a second allele with a CFTR mutation predicted to have residual function ; genotype confirmed at the Screening Visit.
    • Forced Expiratory Volume in 1 Second (FEV1) greater than or equal to (≥) 40 percent (%) and less than or equal to (≤) 90% of predicted normal for age, sex, and height during screening.
    • Sweat chloride value ≥ 60 mmol/L from test results obtained during screening OR as documented in the subject’s medical record.
    • Sweat chloride value <60 mmol/L must have documented evidence of chronic sinopulmonary disease.
    • Stable CF disease as judged by the investigator
    • I soggetti (di sesso maschile e femminile) avranno un’età pari o superiore ai 12 anni alla data del consenso informato o, se del caso, dell’assenso.
    • Eterozigoti per F508del-CFTR e portatori di una mutazione CFTR sul secondo allele con prevista funzione residua; genotipo confermato alla Visita di screening
    • Volume espiratorio forzato in 1 secondo (Forced Expiratory Volume in 1 Second, FEV1) maggiore o uguale al
    (≥) 40 percento (%) e minore o uguale al (≤) 90% del valore normale previsto per età, sesso e altezza durante lo screening
    • Valore del cloruro nel sudore ≥60 mmol/l dai risultati dei test ottenuti durante lo screening OPPURE documentato nella cartella clinica del soggetto
    • Il valore del cloruro nel sudore <60 mmol/l deve presentare un’evidenza documentata di malattia sinopolmonare cronica
    • Malattia FC stabile in base al giudizio dello sperimentatore
    E.4Principal exclusion criteria
    • History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject
    • An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 28 days before Day 1
    • A 12-lead electrocardiogram (ECG) demonstrating corrected QT interval (QTc) greater than (>) 450 milliseconds (msec) at the Screening Visit
    • History of solid organ or hematological transplantation
    • History or evidence of cataract, lens opacity, Y-suture, or lamellar rings determined to be clinically significant by the ophthalmologist during the ophthalmologic examination during the Screening Period
    • Ongoing or prior participation in an investigational drug study (including studies investigating VX-661, lumacaftor [VX-809], and/or ivacaftor) within 30 days of screening
    • Use of restricted medications or foods within the specified window before the first dose of study drug
    • Pregnant and nursing females (females of childbearing potential must have a negative pregnancy test at Screening and Day 1).
    • Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements
    • Colonization with organisms associated with a more rapid decline in pulmonary status
    • Anamnesi di qualsiasi comorbilità che, in base al giudizio dello sperimentatore, possa confondere i risultati dello studio o esporre il soggetto a un rischio aggiuntivo durante la somministrazione del farmaco dello studio
    • Un’infezione acuta delle vie respiratorie superiori o inferiori, esacerbazione polmonare o variazioni della terapia (compresi gli antibiotici) per la malattia polmonare nei 28 giorni prima del Giorno 1
    • Un elettrocardiogramma (ECG) a 12 derivazione che dimostri un intervallo QT corretto (corrected QT, QTc) maggiore di (>) 450 millisecondi (msec) alla Visita di screening
    • Anamnesi di trapianto di organo solido o ematologico
    • Anamnesi o presenza di cataratta, opacità del cristallino, sutura a forma di Y o anelli lamellari giudicati clinicamente significativi da parte dell’oftalmologo all’esame oftalmologico durante il Periodo di screening
    • Partecipazione attuale o pregressa a uno studio su un farmaco sperimentale (inclusi studi di valutazione di VX-661, lumacaftor [VX-809] e/o ivacaftor) nei 30 giorni precedenti lo screening
    • Uso di farmaci o alimenti soggetti a restrizioni nella finestra specificata prima della prima dose di farmaco dello studio
    • Donne in gravidanza e allattamento (le donne in età fertile devono risultare negative al test di gravidanza allo Screening e al Giorno 1).
    • Soggetti fertili sessualmente attivi che non sono disposti ad attenersi ai requisiti contraccettivi
    • Colonizzazione da parte di organismi associati a un più rapido declino dello stato dei polmoni
    E.5 End points
    E.5.1Primary end point(s)
    Absolute change in percent predicted forced expiratory volume in 1 second (FEV1) from study baseline to the average of the Week 4 and Week 8 measurements in each Treatment Period.
    Variazione assoluta del volume espiratorio forzato in 1 secondo (FEV1) dal basale dello studio alla media delle misurazioni della Settimana 4 e della Settimana 8 in ciascun periodo di trattamento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, Week 4 and week 8 of each treatment period

    Basale, Settimana 4 e Settimana 8 di ciascun periodo di trattamento
    E.5.2Secondary end point(s)
    • Relative change in percent predicted FEV1 from study baseline to the average of the Week 4 and Week 8 measurements in each Treatment Period
    • Absolute change in sweat chloride from study baseline to the average of the Week 4 and Week 8 measurements in each Treatment Period
    • Safety and tolerability assessments based on adverse events (AEs), clinical laboratory values, standard digital electrocardiograms (ECGs), vital signs, and pulse oximetry
    • Absolute Change From study Baseline to Average of Week 4 and Week 8 Measurements in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score
    • PK parameters of VX-661, M1-661, ivacaftor, and M1-ivacaftor
    • Variazione relativa del FEV1 previsto in percentuale dal basale dello studio alla media delle misurazioni della Settimana 4 e Settimana 8 in ciascun periodo di trattamento
    • Variazione assoluta del cloruro nel sudore dal basale dello studio alla media delle misurazioni della Settimana 4 e Settimana 8 in ciascun periodo di trattamento
    • Valutazioni della sicurezza e della tollerabilità sulla base di eventi avversi (EA), valori clinici di laboratorio, elettrocardiogrammi (ECG) digitali standard, segni vitali e pulsossimetria.
    • Variazione assoluta dal basale dello studio alla media delle misurazioni della Settimana 4 e Settimana 8 nel punteggio del dominio relativo alla funzionalità respiratoria del Questionario sulla fibrosi cistica - rivisto (Cystic Fibrosis Questionnaire-Revised, CFQ-R)
    • Parametri PK di VX-661, M1-661, ivacaftor e M1-ivacaftor.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Relative change in percent predicted FEV1 from study baseline: Baseline, Week 4 and Week 8 of each treatment period
    • Absolute change in sweat chloride from study baseline: Baseline, Week 4 and Week 8 of each treatment period
    •Safety and tolerability assessments based on adverse events (AEs), clinical laboratory values, standard digital electrocardiograms (ECGs), vital signs, and pulse oximetry: Baseline up to 28 days after last dose (up to 28 weeks)
    •Absolute Change From study Baseline in CFQ-RRespiratory Domain Score: Baseline, Week 4 and Week 8 of each treatment period
    • PK parameters of VX-661, M1-661, ivacaftor, and M1-ivacaftor: day 1 through week 24
    • Variazione relativa del FEV1 previsto in percentuale dal basale dello studio: Basale, Settimana 4 e Settimana 8 di ciascun periodo di trattamento
    • Variazione assoluta del cloruro nel sudore dal basale dello studio: Basale, Settimana 4 e Settimana 8 di ciascun periodo di trattamento
    • Valutazioni di sicurezza e tollerabilità basate su eventi avversi (EA), valori clinici di laboratorio, elettrocardiogrammi (ECG) digitali standard, segni vitali e pulsossimetria: Basale fino a 28 giorni dopo l’ultima dose (fino a 28 settimane).
    • Variazione assoluta dal basale dello studio nel punteggio del dominio respiratorio del CFQ-R: Basale, Settimana 4 e Settimana 8 di ciascun periodo di trattamento
    • Parametri PK di VX-661, M1-661, ivacaftor e M1-ivacaftor: dal Giorno 1 fino alla Settimana 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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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 No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial6
    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 EEA28
    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
    Australia
    Canada
    France
    Germany
    Israel
    Italy
    Netherlands
    Switzerland
    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
    LVLS
    LVLS
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 150
    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: 150
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 150
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children, age 12-17 years old, are included in the study
    specificare:saranno arruolati Adolescenti (12-17 anni)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 300
    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)
    Following the conclusion of the patient's participation in the clinical study, the patient will return to their standard treatment for Cystic Fibrosis. Subjects who complete the Week 24 Visit, regardless of whether they have prematurely discontinued study drug treatment, may be offered the opportunity to enroll in an extension study, if they meet the eligibility criteria for the extension study.
    Successivamente alla conclusione della propria partecipazione allo studio clinico, il/la paziente ritornerà al proprio trattamento standard per la fibrosi cistica. Ai soggetti che completano la visita della Settimana 24, indipendentemente dal fatto che abbiano interrotto prematuramente il trattamento con il farmaco dello studio, potrà essere offerta l’opportunità di arruolarsi in uno studio di estensione, qualora soddisfino i criteri di idoneità per lo studio di estensione.
    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 Decision2015-07-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-25
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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