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    Summary
    EudraCT Number:2011-000443-24
    Sponsor's Protocol Code Number:TR02-110
    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:2012-03-19
    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 number2011-000443-24
    A.3Full title of the trial
    Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa
    Studio di sicurezza e tollerabilita' a lungo termine, in aperto sull'™amikacina liposomiale per via inalatoria (Arikace) in pazienti con fibrosi cistica associata ad infezione cronica da Pseudomonas aeruginosa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa
    Studio di sicurezza e tollerabilita' a lungo termine su Arikace™ in pazienti con fibrosi cistica associata ad infezione cronica da Pseudomonas aeruginosa
    A.4.1Sponsor's protocol code numberTR02-110
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01316276
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/031/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorINSMED 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 supportInsmed Incoporated
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInsmed Limited
    B.5.2Functional name of contact pointRenu Gupta
    B.5.3 Address:
    B.5.3.1Street Address5 - 10 St. Paul's Churchyard
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC4M 8AL
    B.5.3.4CountryItaly
    B.5.4Telephone number+1 732 997 4526
    B.5.5Fax number+1 732 997 4599
    B.5.6E-mailcf@insmed.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/3/06/387
    D.3 Description of the IMP
    D.3.1Product nameLiposomal Amikacin
    D.3.2Product code NA
    D.3.4Pharmaceutical form Nebuliser suspension
    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 INNAMIKACIN SULFATE
    D.3.9.1CAS number 398-31-555
    D.3.9.4EV Substance CodeSUB00444MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 Yes
    D.3.11.13.1Other medicinal product typedispersione sterile liposomiale di amikacina solfato
    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
    Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
    Infezione/colonizzazione polmonare da Pseudomonas aeruginosa in pazienti con 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 14.1
    E.1.2Level PT
    E.1.2Classification code 10011763
    E.1.2Term Cystic fibrosis lung
    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 longer term safety, tolerability and efficacy of Arikace™ 560 mg administered once daily for up to twelve cycles with each cycle consisting of 28 days on-treatment followed by 28 days off treatment.
    Valutare la sicurezza, tollerabilità ed efficacia a lungo termine di Arikace™ 560 mg somministrato una volta al giorno per un massimo di dodici cicli, ciascuno dei quali consiste di 28 giorni di trattamento intervallati da 28 senza farmaco
    E.2.2Secondary objectives of the trial
    None
    Nessuno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Written informed consent or assent obtained from the subject, parent or legal guardian to participate in the open label multi-cycle study, TR02- 110 2) Subject has completed study TR02-108 or TR02-109, and has been compliant with the study protocol 3) Negative pregnancy result on pregnancy test performed within 2 weeks prior to Day 1 and use of reliable methods of contraception (e.g., abstinence, hormonal or barrier methods, partner sterilization, or IUD) throughout the study duration in women of child-bearing potential. Women not of childbearing potential are defined as prepubescent, postmenopausal (i.e., amenorrhea for at least 1 year), or surgically or naturally sterile
    1) Consenso o assenso informato scritto alla partecipazione allo studio di più cicli, in aperto TR02-110, acquisito dal soggetto, dal genitore o dal tutore legale. 2) Il soggetto ha completato lo studio TR02-108 o TR02-109 e ha rispettato il protocollo dello studio. 3) Risultato negativo del test di gravidanza effettuato entro le 2 settimane precedenti al Giorno 1 e uso di metodi contraccettivi affidabili (ad es., astinenza, metodi ormonali o di barriera, sterilizzazione del partner o IUD) per l’intera durata dello studio nelle donne potenzialmente fertili. Per donne non potenzialmente fertili si intendono ragazze prepubescenti, donne postmenopausali (ossia amenorreiche da almeno 1 anno), oppure sterili (sia di origine organica che chirurgica).
    E.4Principal exclusion criteria
    1) Subject met any of the listed criteria for study drug discontinuation (safety reasons or non-compliance) in protocol TR02-108 or TR02-109 2) Elevated AST, ALT or GGT ≥ 3× the upper limit of normal (ULN) within 4 weeks prior to Day 1 3) Absolute neutrophil count < 1000 within 4 weeks prior to Day 1 4) Serum creatinine > 2× ULN within 4 weeks prior to Day 1 5) Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements. 6) History of alcohol, medication, or illicit drug abuse within the 6 months prior to consent 7) Smoking tobacco or any substance within 6 months prior to consent or anticipated inability to refrain from smoking throughout the study 8) Any condition which in the opinion of the investigator interferes with the subject's ability to safely complete the study or adhere to the study requirements
    1) • Soggetti che hanno soddisfatto uno qualsiasi dei criteri per la sospensione del farmaco (per motivi di sicurezza o di non compliance) elencati nel protocollo TR02-108 o TR02-109. 2) Elevati valori di AST, ALT o GGT ≥3 volte il limite superiore della norma (LSN) nelle 4 settimane precedenti al Giorno 1. 3) Conta assoluta dei neutrofili &lt;1000 nelle 4 settimane precedenti al Giorno 1. 4) Creatinina sierica &gt;2 volte il LSN nelle 4 settimane precedenti al Giorno 1. 5) Disturbi psicotici, da dipendenza o altro disturbo che limita la capacità di accordare il consenso informato o di aderire ai requisiti dello studio. 6) Anamnesi di etilismo, farmacodipendenza o tossicodipendenza nei 6 mesi precedenti l’acquisizione del consenso. 7) Tabagismo o consumo di altre sostanze nei 6 mesi precedenti l’acquisizione del consenso, oppure la prevista incapacità di astenersi dal fumo per l’intera durata dello studio. 8) Qualsiasi condizione che, a giudizio dello sperimentatore, influenzi la capacità del soggetto di completare in modo sicuro lo studio, o di aderire ai requisiti dello stesso.
    E.5 End points
    E.5.1Primary end point(s)
    1) Treatment emergent adverse events (AE) up to Day 672 2) Adverse events leading to permanent discontinuation of study drug 3) Serious adverse events (SAE) up to Day 672 4) Laboratory abnormalities up to Day 672 5) Acute tolerability as measured by PFT changes pre to post dose 6) Vital signs and oxygen saturation (change from pre to post-dose) and change from baseline 7) Shift in MICs for Pa and Burkholderia species from Day 1 to Days 169, 337, 505 and 672 8) Proportion of subjects with emergent pathogens 9) Evaluation of audiology 10) Change in serum creatinine throughout study 11) Concomitant medications including antibiotics, antivirals, antifungals and other inhalant medications such as bronchodilators, DNase, inhaled steroids
    1) Eventi avversi (AE) emergenti dal trattamento fino al Giorno 672. 2) Eventi avversi che portano alla sospensione permanente del farmaco in studio. 3) Eventi avversi seri (SAE) fino al Giorno 672. 4) Anomalie nei parametri di laboratorio fino al Giorno 672. 5) Tollerabilità acuta, misurata dalle variazioni delle PFT da prima a dopo la somministrazione della dose. 6) Segni vitali e saturazione d’ossigeno (variazione da prima a dopo la somministrazione della dose) e variazione dalla basale. 7) Deviazione nelle MIC per Pa e Burkholderia species dal Giorno 1 ai Giorni 169, 337, 505 e 672. 8) Proporzione di soggetti presentanti patogeni emergenti. 9) Valutazione audiologica 10) Variazione della creatinina sierica per l’intera durata dello studio. 11) Farmaci concomitanti, compresi antibiotici, antivirali, antifungini e altri farmaci inalatori, come broncodilatatori, DNasi, steroidi inalatori.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After the first phase of the study (6 cycles and ~356 days). Then reconsented patients will enter into a second phase (an additional 6 cycles and ~356 days)
    Dopo la prima fase dello studio (6 cicli e circa 356 giorni). I pazienti che daranno di nuovo il consenso entreranno in una seconda fase (altri 6 cicli e circa 356 giorni)
    E.5.2Secondary end point(s)
    1) Relative change in FEV1 [liters], and FEV1 (% predicted) throughout the study 2) Time to first protocol defined pulmonary exacerbation and proportion of subjects experiencing a protocol defined pulmonary exacerbation 3) Time to first antipseudomonal antibiotic treatment for protocol defined pulmonary exacerbation, proportion of subjects initiating treatment and number of days of treatment Exploratory Endpoints 1) Time to first investigator defined pulmonary exacerbation and proportion of subjects experiencing an investigator defined pulmonary exacerbation 2)Time to first pulmonary exacerbation defined using Seattle Score (Rosenfeld Criteria) and proportion of subjects experiencing a pulmonary exacerbation defined using Seattle Score 3) Time to first antipseudomonal antibiotic treatment for any pulmonary exacerbation (protocol defined or investigator defined), proportion of subjects initiating treatment and number of days of treatment 4) Log CFU Pa and change in log CFU Pa from baseline throughout study 5) Log CFU Burkholderia species and change in log CFU Burkholderia species from baseline throughout study 6) Time to, number of and length of hospitalizations and proportions of subjects hospitalized for any cause 7) Time to, number of and length of hospitalizations and proportions of subjects hospitalized for pulmonary exacerbation 8) Change in patient reported symptoms from baseline throughout study as measured by the Cystic Fibrosis Respiratory Symptoms Diary (CFRSD) (instrument is only available in English and will therefore only be completed in English speaking countries by subjects who are comfortable reading and speaking English) 9) Change in respiratory symptoms from baseline throughout study as measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R) 10) Evaluation of Global Rating of Health (GRH) at each study visit and change from baseline throughout study 11) Proportion of subjects reporting days missed from work or school due to underlying complications of CF and number of days missed 12) FEV1 (liters), and FEV1 (% predicted) throughout the study and absolute change in FEV1 (liters), and FEV1 (% predicted) throughout the study; forced vital capacity (FVC) and forced expiratory flow (FEF(25-75%)) throughout study and absolute change in and relative change in FVC and FEF(25-75%) throughout study 13) Evaluation of time to and frequency of pulmonary exacerbations, relative change in FEV1(liters) and FEV1 % predicted, time to antipseudomonal rescue treatment, log CFU change, change in CFQRRespiratory domain, change in CFRSD and change in GRH by FEV1 % predicted, age and additional sub-groups
    • Variazione relativa del FEV1 [litri] e FEV1 (% rispetto al predetto) per l’intera durata dello studio. • Tempo alla prima esacerbazione polmonare definita dal protocollo, e proporzione di soggetti colpiti da un’esacerbazione polmonare definita dal protocollo. • Tempo alla prima terapia antibiotica anti Pseudomonas per esacerbazione polmonare definita dal protocollo, proporzione di soggetti che iniziano la terapia e numero di giorni di terapia. Endpoint esploratori • Tempo alla prima esacerbazione polmonare definita dallo sperimentatore, e proporzione di soggetti presentanti esacerbazione polmonare definita dallo sperimentatore. • Tempo alla prima esacerbazione polmonare definita utilizzando il punteggio Seattle Score (criteri di Rosenfeld) e proporzione dei soggetti presentanti esacerbazione polmonare definita utilizzando il punteggio Seattle Score. • Tempo alla prima terapia antibiotica anti Pseudomonas per qualsiasi esacerbazione polmonare (definita dal protocollo o dallo sperimentatore), proporzione dei soggetti che iniziano la terapia e numero dei giorni di trattamento. • Log UFC di Pa e variazione dello stesso dalla basale per l’intera durata dello studio. • Log UFC di Burkholderia species e variazione dello stesso dalla basale per l’intera durata dello studio. • Tempo al ricovero, numero di ricoveri, durata della degenza e proporzione di soggetti ricoverati per ogni causa. • Tempo al ricovero, numero di ricoveri, durata della degenza e proporzione di soggetti ricoverati per esacerbazione polmonare. • Variazione dei sintomi segnalati dal paziente dalla basale per l’intera durata dello studio, determinati utilizzando il diario CFRSD (Cystic Fibrosis Respiratory Symptoms Diary) (lo strumento è disponibile solo in lingua inglese e, pertanto, sarà compilato solo nei paesi di lingua inglese da soggetti fluenti nell’inglese parlato e scritto). • Variazione dei sintomi respiratori dalla basale durante l’intero studio, come determinato dal questionario specifico per la fibrosi cistica (CFQ-R, Cystic Fibrosis Questionnaire-Revised). • Valutazione dello stato globale di salute GRH (Global Rating of Health) ad ogni visita e variazione dalla basale per l’intera durata dello studio. • Proporzione di soggetti che segnalano giorni di lavoro o scuola persi a causa delle complicanze sottese della FC e numero di giorni persi. • FEV1 (litri) e FEV1 (% rispetto al predetto) per l’intera durata dello studio e variazione assoluta del FEV1 (litri) e FEV1 (% rispetto al predetto) per l’intera durata dello studio; capacità vitale forzata (CVF) e flusso espiratorio forzato (FEF(25-75%)) per l’intera durata dello studio e variazione assoluta e relativa della CVF e del FEF(25-75%) per l’intera durata dello studio. Valutazione del tempo alle esacerbazioni polmonari e frequenza delle stesse, variazione relativa del FEV1(litri) e del FEV1 % rispetto al predetto, tempo alla terapia di soccorso anti Pseudomonas, variazione del log UFC, variazione nel dominio della respirazione del CFQ-R, variazione del CFRSD e variazione del GRH per FEV1 % rispetto al predetto, età e sottogruppi addizionali.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1 to Day 672
    da Giorno 1 al giorno 672
    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 Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tollerabilità
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) 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 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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA92
    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
    New Zealand
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 50
    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: 25
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    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
    In case of Patients under the age of 18, consent should be also given by parents/guardians.
    Per pazienti minori di 18 anni, il consenso dovrà essere dato dai genitori/tutore
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 250
    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)
    Normal treatment of condition
    Normali condizioni di 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 Cystische Fibrose - Netzwerk Klinische Studien
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Cystic Fibrosis Foundation Therapeutics - Therapeutics Development Network
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation European Cystic Fibrosis Society - Clinical Trial
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation Cystic Fibrosis - National Knowledge Service (UK CFNKS)
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-04-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-03-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-16
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