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    Summary
    EudraCT Number:2016-003835-39
    Sponsor's Protocol Code Number:FSS-AS-30003
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-02-21
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2016-003835-39
    A.3Full title of the trial
    A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared with Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler in Patients Aged 4 Through 11 Years with Persistent Asthma
    12 hetes, randomizált, kettős vak, placebo-kontrollált vizsgálat a flutikazon-propionát többadagos száraz por inhalátor hatásosságának és biztonságosságának flutikazon-propionát/szalmeterol többadagos száraz por inhalátorral szembeni értékelésére 4–11 éves, perzisztáló asztmában szenvedő betegeknél
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A 12-Week study to find out if Fluticasone Propionate or Fluticasone/Salmeterol are safe and effective to treat children from 4 to 11 Years old with asthma.
    A.4.1Sponsor's protocol code numberFSS-AS-30003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02980133
    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 SponsorTeva Branded Pharmaceutical Products R&D, 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 supportTeva Branded Pharmaceutical Products R&D, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva GmbH
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressGraf-Arco-Str. 3
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89079
    B.5.3.4CountryGermany
    B.5.6E-mailInfo-era-clinical@teva.de
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFluticasone Propionate multidose dry powder inhaler (Fp MDPI)
    D.3.2Product code Fp MPDI
    D.3.4Pharmaceutical form Inhalation powder
    D.3.4.1Specific paediatric formulation Yes
    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 INNFLUTICASONE PROPIONATE
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFluticasone Propionate/Salmeterol Xinafoate Multidose Dry Powder Inhaler (FS MDPI)
    D.3.2Product code FS MDPI
    D.3.4Pharmaceutical form Inhalation powder
    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 INNFLUTICASONE PROPIONATE
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSALMETEROL XINAFOATE
    D.3.9.1CAS number 94749-08-3
    D.3.9.3Other descriptive nameSALMETEROL XINAFOATE
    D.3.9.4EV Substance CodeSUB04314MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameFluticasone Propionate multidose dry powder inhaler (Fp MDPI)
    D.3.2Product code Fp
    D.3.4Pharmaceutical form Inhalation powder
    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 INNFLUTICASONE PROPIONATE
    D.3.9.1CAS number 80474-14-2
    D.3.9.3Other descriptive nameFLUTICASONE PROPIONATE
    D.3.9.4EV Substance CodeSUB02241MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 placeboInhalation powder
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Persistent asthma
    E.1.1.1Medical condition in easily understood language
    Asthma
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10003553
    E.1.2Term Asthma
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of Fp MDPI and FS MDPI when administered over 12 weeks in patients 4 through 11 years of age with persistent asthma.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the safety and tolerability of Fp MDPI and FS MDPI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. The patient is a male or female patient 4 through 11 years of age, inclusive, when informed consent/assent (as applicable) is signed.
    b. Written informed consent must be signed and dated by parent/legal guardian and the written informed assent form must be signed and dated by the patient (as applicable, per local regulations) before any study-related procedures are conducted.
    c. The patient has a diagnosis of asthma as defined by the NIH. The asthma diagnosis has been present for a minimum of 3 months before SV.
    d. The patient has persistent asthma with a FEV1 ≥50% and ≤90% of the value predicted for age, height, sex, and race at the SV as measured by handheld device.
    e. The patient’s persistent asthma is stable and is currently being treated with stable asthma therapy for at least 30 days before the SV. Patients who are currently on SABA regimen only or PRN only are not eligible for the study.
    f. The patient has demonstrated ≥10% response to a bronchodilator from screening FEV1 within 30 minutes after 2 to 4 inhalations of albuterol/salbutamol HFA MDI (90 mcg ex-actuator) or equivalent at SV as measured by handheld device. Patients who demonstrated <10% response to a bronchodilator may retest within 7 days of their initial SV.
    Patients who demonstrate response to a bronchodilator ≥10% and <14.50% may enter the run-in period (provided that they meet the other inclusion and none of the exclusion criteria) and may present for repeat lung function assessments by handheld device and another bronchodilator test within 14±2 days, during which they must demonstrate at least a 15% response to a bronchodilator. If the criteria are not met, patients may continue in the run-in period for up to 14 additional days to meet the lung function assessment and response to bronchodilator criteria (1 final attempt) for randomization. Patients may only continue in the run-in period if the investigator determines, by assessing the patient’s asthma status (at each investigational center visit), that it is safe for the patient to continue.
    g. The patient (with assistance from parents/legal guardians/caregivers, as needed) is able to perform technically acceptable lung function assessments by handheld device. Patients who fail to demonstrate technically acceptable lung function assessments may retest within 7 days of their initial SV.
    h. The patient (with assistance from parents/legal guardians/caregivers, as needed) is able to use an MDI device and an MDPI device.
    i. The patient is able to withhold (as judged by the investigator) his/her rescue medication for at least 6 hours before SV and all TVs where lung function assessments are performed.
    j. The patient is assessed as otherwise healthy, with clinically acceptable medical history, physical examination, and vital signs within acceptable ranges for children with asthma as assessed by the investigator.
    k. All patients must be able to replace their current SABA with albuterol/salbutamol HFA MDI inhalation aerosol at the SV for use as needed for the duration of the study.
    l. Female patients who have reached puberty and achieved menarche (as determined by the investigator) must be counseled regarding the possible unknown risks associated with IMP during pregnancy following permission of the parents/legal guardians. A urine pregnancy test must be negative for these patients at SV. Eligible female patients who are known to be sexually active will be excluded.
    m. Eligible male patients who are known to be sexually active will be excluded.
    E.4Principal exclusion criteria
    a. The patient has a history of life-threatening asthma exacerbation (asthma episode that required intubation and/or was associated with hypercapnia, respiratory arrest, or hypoxic seizures).
    b. The patient is pregnant or lactating or plans to become pregnant during the study period or within 30 days after the patient’s last study-related visit.
    c. The patient has participated as a randomized patient in any investigational drug study within the 30 days or within 5 half-lives preceding the SV (or prescreening visit) or plans to participate in another investigational drug study at any time during this study.
    d. The patient has a known hypersensitivity to any corticosteroid, salmeterol, or any of the excipients in the IMP or rescue medication formulation. Dietary lactose intolerance does not exclude from inclusion or as per the investigator’s medical discretion.
    e. The patient has been treated with any known strong cytochrome P450 (CYP) 3A4 inhibitors within 30 days before the SV or plans to be treated with any strong CYP3A4 inhibitor during the study.
    f. The patient has been treated with any of the prohibited medications during the prescribed washout periods before the SV.
    g. The patient currently smokes or has a smoking history. The patient must not have used tobacco products within the past year.
    h. The patient has a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus, or middle ear that has not resolved at least 2 weeks before the SV (note: patients who develop a URI or LRI during the run-in period may be rescreened 2 weeks after symptoms resolve).
    i. The patient has had an asthma exacerbation requiring systemic corticosteroids within 30 days before the SV or has had any hospitalization for asthma within 2 months before the SV.
    j. Initiation or dose escalation of immunotherapy (administered by any route) is planned during the study period. However, patients who initiated immunotherapy 90 days or more before the SV and have been on a stable (maintenance) dose for 30 days or more before the SV may be considered for inclusion.
    k. The patient has used immunosuppressive medications within 30 days before the SV.
    l. The patient is unable to tolerate or unwilling to comply with the appropriate washout periods and withholding of all applicable medications.
    m. The patient has untreated oral candidiasis at the SV. Patients with clinical visual evidence of oral candidiasis who agree to receive treatment and comply with appropriate medical monitoring may enter the run-in period.
    n. The patient has a history of a positive test for HIV, active hepatitis B virus, or hepatitis C infection.
    o. The patient is an immediate relative of an employee of the clinical investigational center.
    p. A member of the patient’s household is participating in the study at the same time. However, after the enrolled patient completes or discontinues participation in the study, another patient from the same household may be screened.
    q. The patient has a disease/condition that, in the medical judgment of the investigator, would put the safety of the patient at risk or that could affect the efficacy or safety analysis if the disease/condition worsened during the study. Examples include/ not limited to:
    -cardiovascular conditions including clinically significant cardiac arrhythmia, known aortic aneurysm, congenital heart disease, coronary heart disease, or vital signs clinically unacceptable for ranges in children with asthma as assessed by the investigator
    -hepatic, renal, hematologic, neuropsychologic, or endocrine conditions (eg, sickle cell disease, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison’s disease, Cushing’s syndrome, stroke within 3 months before the SV)
    -gastrointestinal conditions (eg, poorly controlled peptic ulcer, poorly controlled gastroesophageal reflux)
    -infectious/immunologic conditions including untreated tuberculosis (a history of tuberculosis is acceptable only if a patient has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years) and immunologic compromise
    -ocular conditions including glaucoma, ocular herpes simplex, or cataracts
    -oncologic conditions including any current malignancy, excluding basal cell carcinoma. History of malignancy is acceptable only if the patient has been in remission for 1 year before the SV. Remission is defined as no current evidence of malignancy and no treatment for the malignancy in the 12 months before the SV.
    -pulmonary conditions including chronic bronchitis, emphysema, chronic bronchiectasis, cystic fibrosis, chronic lung disease, or chronic obstructive pulmonary disease -renal conditions including chronic renal failure or ongoing dialysis
    -history of or planned solid organ transplant
    r. Vulnerable patients (ie, people kept in detention) are excluded from participation.
    E.5 End points
    E.5.1Primary end point(s)
    -For Fp MDPI versus placebo: the change from baseline in weekly average of the percent predicted trough morning FEV1 at week 12
    -For FS MDPI versus Fp MDPI: the change from baseline in 1-hour postdose percent predicted morning FEV1 at week 12
    E.5.1.1Timepoint(s) of evaluation of this end point
    The baseline percent predicted FEV1 will be the weekly average of the morning FEV1 prior to the first IMP dose. The first day before randomization consists of the entry on the morning of the RV in the patient diary built into the handheld device. The weekly average of the percent predicted FEV1 at week 12 will be the average values based on the available data at that week.

    For the endpoint of change from baseline in 1-hour postdose percent predicted morning FEV1 (measured at the clinic) at week 12, baseline is defined as predose FEV1 measurements obtained at the clinic at the RV with the handheld device immediately prior to the IMP administration.

    E.5.2Secondary end point(s)
    Secondary efficacy endpoints:
    -Change from baseline in the weekly average of daily trough morning (predose and pre-rescue bronchodilator) PEF over the 12-week treatment period
    -Change from baseline in the weekly average of total daily (24-hour) use of albuterol/salbutamol inhalation aerosol (number of inhalations) over weeks 1 through 12
    -Change from baseline in the weekly average of the total daily asthma symptom score (defined as the average of the daytime and nighttime scores) over weeks 1 through 12
    -Change from baseline in asthma control (measured by Childhood Asthma Control Test [C-ACT]) over the 12-week treatment period
    -Time to first onset of effect defined as the first decrease from baseline in daily rescue medication use
    -Proportion of patients discontinued from IMP for asthma exacerbation during the 12-week treatment period

    Safety endpoints:
    -Incidence of adverse events throughout the study
    -Vital signs assessments throughout the study
    -Oropharyngeal examination findings at each visit
    -Physical examination findings at baseline and at week 12 or at the IMP discontinuation visit (IMPDV)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary efficacy endpoints:
    Recorded in patient diary daily throughout 12 week study treatment period: during the treatment period (RV through TV6 [week 12] or IMPDV), daily in the morning and evening at approximately the same time each day, patients will use the handheld device at home to record asthma symptom scores and rescue albuterol/salbutamol HFA MDI use, after which they will perform lung function assessments (FEV1 and PEF) and then will take their dose of the IMP and record IMP dosing in the patient diary built into the handheld device.
    Safety measures and time points are as follows:
    -inquiries about adverse events at all visits
    -vital signs measurements at all visits
    -oropharyngeal examinations at all visits
    -physical examinations at baseline and week 12 or at the IMPDV
    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 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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 EEA25
    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
    Georgia
    Hungary
    Poland
    Russian Federation
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days15
    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: 824
    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: 824
    F.1.1.6Adolescents (12-17 years) No
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Minors
    F.4 Planned number of subjects to be included
    F.4.1In the member state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 824
    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)
    No IMP will be provided beyond completion of the study. Patients should return to their primary care physician for treatment after study completion.
    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 Decision2017-03-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-13
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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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