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    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).

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    Summary
    EudraCT Number:2015-004631-13
    Sponsor's Protocol Code Number:MBCT206
    National Competent Authority:Latvia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-03
    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 ConcernedLatvia - SAM
    A.2EudraCT number2015-004631-13
    A.3Full title of the trial
    A Phase IIa, two-part, randomised, multi-centre, multinational, double-blind, placebo-controlled, parallel group study to compare the efficacy and safety of BCT197 when added on to standard of care for the treatment of acute respiratory exacerbations of chronic obstructive pulmonary disease (COPD) requiring hospitalisation in adults.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to compare the efficacy and safety of BCT197 when it is used together with current treatments for acute respiratory exacerbations of chronic obstructive pulmonary disease (COPD) that result in hospitalisation in adults
    A.4.1Sponsor's protocol code numberMBCT206
    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 SponsorMereo BioPharma 1 Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportMereo BioPharma 1 Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationICON Clinical Research
    B.5.2Functional name of contact pointProject Management
    B.5.3 Address:
    B.5.3.1Street AddressSouth County Business Park
    B.5.3.2Town/ cityLeopardstown
    B.5.3.3Post codeDublin 18
    B.5.3.4CountryIreland
    B.5.4Telephone number+3531291 2000
    B.5.5Fax number+3531247 6260
    B.5.6E-mailKaren.VanHulst@iconplc.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBCT197 20mg hard gelatine capsules
    D.3.4Pharmaceutical form Capsule, hard
    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 INNAcumapimod
    D.3.9.1CAS number 836683-15-9
    D.3.9.2Current sponsor codeBCT197
    D.3.9.4EV Substance CodeSUB31871
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 nameBCT197 25mg hard gelatine capsules
    D.3.4Pharmaceutical form Capsule, hard
    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 INNAcumapimod
    D.3.9.1CAS number 836683-15-9
    D.3.9.2Current sponsor codeBCT197
    D.3.9.4EV Substance CodeSUB31871
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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: 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 nameBCT197 50mg hard gelatine capsules
    D.3.4Pharmaceutical form Capsule, hard
    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 INNAcumapimod
    D.3.9.1CAS number 836683-15-9
    D.3.9.2Current sponsor codeBCT197
    D.3.9.4EV Substance CodeSUB31871
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 placeboCapsule, hard
    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
    Acute exacerbations of chronic obstructive pulmonary disease
    E.1.1.1Medical condition in easily understood language
    Worsening of respiratory function in patients with chronic obstructive pulmonary disease
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10010953
    E.1.2Term COPD exacerbation
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of two different dosing regimens of BCT197 added to standard of care (SoC) versus placebo added to SoC in the treatment of acute respiratory exacerbations of COPD that required hospitalisation by comparison of change in forced expiratory volume in 1 second (FEV1) from Baseline (pre-dose) to Day 7.
    E.2.2Secondary objectives of the trial
    - To evaluate the efficacy and tolerability of two different dosing regimens of BCT197 added to SoC versus placebo added to SoC in treatment of an acute exacerbation of COPD.

    - Safety and tolerability of BCT197
    - Please see protocol for exploratory objectives
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female adults aged ≥ 40 years
    2. Written informed consent obtained prior to any study-related procedure
    3. Presence of an active exacerbation of the ongoing COPD requiring hospitalisation for treatment:
    “A sustained worsening of the patient’s condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD that includes prescriptions of systemic corticosteroids and/or antibiotics and need for hospitalisation”
    4. Subjects with a diagnosis of COPD with spirometry performed outside an exacerbation within the last 12 months prior to the Screening Visit.
    5. Current smokers or ex-smokers with a smoking history of at least 10 pack-years (pack-years = [number of cigarettes per day x number of years/20])
    6. A FEV1 < 65% of the predicted normal value.
    7. A documented history of at least one moderate or severe COPD exacerbation in the 12 months preceding the Screening Visit that required antibiotics and/or systemic corticosteroid (addition or increment on subject current use) as defined below:
    o “A sustained worsening of the patient’s condition (dyspnoea, cough and/or sputum production/purulence), from the stable state and beyond normal day-to-day variations, that is acute in onset and necessitates a change in regular medication in a patient with underlying COPD that includes prescriptions of systemic corticosteroids and/or antibiotics or need for hospitalisation”
    o Also, documented visits to an emergency department due to COPD exacerbation are considered acceptable to fulfil this criterion.
    8. Current regular treatment for COPD (categories C and D according to GOLD guidelines, updated 2015) for at least 2 months prior to the Screening Visit with either:
    • Inhaled corticosteroids/long-acting β2-agonist combination, long-acting muscarinic antagonist without regular use of any short-acting bronchodilator (any short-acting bronchodilator allowed if used as needed [PRN]) or
    • Inhaled corticosteroids/long-acting β2-agonist combination, without regular use of any short-acting bronchodilator (any short-acting bronchodilator allowed if used PRN) or
    • Inhaled corticosteroids/long-acting muscarinic antagonist combination, without regular use of any short-acting bronchodilator (any short-acting bronchodilator allowed if PRN) or
    • Inhaled long-acting β2-agonist and inhaled long-acting muscarinic antagonist (with any PRN short acting bronchodilator) or
    • Subjects under monotherapy with long-acting muscarinic antagonist (with any PRN short acting bronchodilator).
    9. Ideally subjects should be screened, randomised and dosed on the same day. Where information is not available, the Screening period can be extended to a maximum of 24 hours before Randomisation and dosing.
    E.4Principal exclusion criteria
    1. Current diagnosis of asthma
    2. Subjects who have already completed treatment for current exacerbation of COPD
    3. Subjects who have been treated with or require the following medications:
    • Systemic steroids for longer than 3days for COPD exacerbation in the 4weeks prior to the current exacerbation
    • Antibiotics for COPD exacerbation for longer than 7days in the 4weeks prior to the current exacerbation
    • Phosphodiesterase type 3/4 inhibitors
    • Any p38 mitogen-activated protein kinase inhibitor treatment
    • Antibiotics for lower respiratory tract infection in the 4weeks prior to the current exacerbation (except for treatment of the current exacerbation, but not longer than 2days)
    4. Subjects currently requiring intensive care unit and/or mechanical ventilation
    5. Subjects treated with non-cardioselective β-blockers in the 10days preceding Screening Visit. Those subjects may enter the study after non-selective β-blockers withdrawal and/or cardioselective β-blockers intake for at least 10days before Randomisation
    6. Subjects treated with long-acting anti-histamines unless taken at stable regimen at least 2months prior to Screening and to be maintained constant during the study, or if taken as PRN
    7. Subjects requiring long term (at least 12hrs daily) oxygen therapy for chronic hypoxemia
    8. Known respiratory disorders other than COPD which may impact efficacy of study drug according to the investigator’s judgement. This can include but is not limited to α-1 antitrypsin deficiency, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension and interstitial
    lung disease
    9. Subjects who have had pulmonary lobectomy or lung volume reduction surgery or lung transplantation
    10. Subjects who have had a vaccination in the 14days (or 30days for live vaccines) prior to study start
    11. Subjects who have a clinically significant cardiovascular condition (including, but not limited to, unstable ischemic heart disease, NYHA Class III/IV, left ventricular failure, acute myocardial infarction); or current exacerbation is due to a cardiovascular condition
    12. An abnormal and clinically significant 12-lead ECG which may impact safety of the subject according to the investigator’s judgement at Screening or Baseline
    13. Subjects whose 12-lead ECG shows QTcF > 450 msec at Screening and at Randomisation visits; ECG does not need to be repeated if Screening and Randomisation visit are on the same day
    14. Current diagnosis of pneumonia, pulmonary embolus or pneumothorax.
    15. History of hypersensitivity to anti-cholinergics, β2-agonist, corticosteroids or any excipients contained in the formulations used in the study which may raise contra-indications or impact the efficacy of the study drug according to the investigator’s clinical judgement
    16. Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study drug according to the investigator’s clinical judgement
    17. Subjects with liver enzyme alterations (serum alanine aminotransferase and/or aspartate aminotransferase > 2 x upper limit of normal [ULN], bilirubin > 1.5 ULN)
    18. Impairment of renal function (defined as creatinine clearance < 60 mL/min (estimated by Cockcroft-Gault)
    19. Concomitant/recent use of the CYP3A inhibitors or P-gp inhibitors including, but not limited to macrolide antibiotics and the calcium channel blockers verapamil and diltiazem; consumption of grapefruit is also excluded.
    20. Unstable concurrent disease: e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; uncontrolled gastrointestinal disease; uncontrolled neurological disease; uncontrolled haematological disease; uncontrolled auto-immune disorders, or other which may impact the efficacy or the safety of the study drug according to the investigator’s judgement
    21. History of alcohol abuse and/or substance/drug abuse within 12months prior to the Screening Visit
    22. Participation in another interventional clinical study where the investigational drug was received within < 5 x half-lives of the drug or 8weeks (whichever is longer) (6months in the case of a monoclonal antibody) prior to Screening Visit. Participation in observational/non-interventional studies is allowed.
    23. Pregnant or nursing women
    24. Sexually active men unless they are using double barrier method for the period of dosing and for the 5 half-lives (8days) afterwards
    25. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 8days after treatment with investigational medication
    E.5 End points
    E.5.1Primary end point(s)
    Change in FEV1 from Baseline (pre-dose) at Day 7.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Please refer to protocol (Table 9-1 Schedule of Assessments).
    E.5.2Secondary end point(s)
    Efficacy:
    1. Comparison of forced expiratory volume in 1 second (FEV1) on Days 3, 10, and 14
    2. Normalisation evaluation of spirometry parameter (FEV1, FVC, and FEV1/FVC) response over time (performed daily from Days 1 to 7, 10, and 14, and Weeks 8, 12 and 26) compared with the most recent test performed within the last 12 months outside an exacerbation (pre-study FEV1 , FVC, and FEV1/FVC value)
    3. Time taken to improvement of 100 mL in FEV1 compared to Baseline versus placebo
    4. Comparison of AUC of FEV1 over time among groups
    5. Change in RR over time (performed daily from Days 1 to 7, 10 and 14) among groups
    6. Change in RR on Days 3, 7, 10 and 14 among groups
    7. Time to improvement based on EXACT-PRO total score
    8. Comparison of AUC of EXACT-PRO over time among groups
    9. Number of COPD-related deaths during the study
    10. Number of moderate/severe COPD-related exacerbations during the study
    11. Time to next moderate/severe COPD exacerbation
    12. Change from Baseline at each inter-visit period and over the entire period of the study in the average EXACT-PRO total score and domain scores
    13. Number of times each subject required rescue therapy during the study
    14. Time from hospitalisation until the subject is medically ready (COPD-related) for discharge
    15. Nonlinear mixed effects pharmacokinetic/pharmacodynamics (PK/PD) models evaluating the relationship between BCT197 exposure and efficacy/safety endpoints.

    Safety:
    1. TEAEs/SAEs (from first dose of study drug until study completion)
    2. Evaluation of the incidence of pneumonia from first dose of study drug until completion
    3. TEAEs of special interest (liver enzymes [ALT, AST, bilirubin total and
    fractions], rash, acneiform dermatitis, cervical/vaginal inflammation,
    headache and pruritus)
    4. Vital signs (oral body temperature, RR, pulse rate, blood oxygen [measured using a pulse oximeter], systolic and diastolic blood pressure)
    5. QTc intervals at Baseline, from Day 1 to Day 7 (daily), Days 10 and 14
    6. Laboratory data including sputum cultures and blood eosinophil percentages.

    Exploratory:
    1. Exploratory composite scale comparing the following among the three groups at Weeks 8, 12 and 26:
    o Number of events of worsening symptoms warranting the addition of antibiotics
    o Number of events of worsening of symptoms warranting an increase of oral dose corticosteroids or initiation of new oral corticosteroids
    o Number of events of worsening of symptoms requiring additional treatment with oral corticosteroids and/or antibiotics after completion of the initial regimen
    o Number of events of COPD exacerbations that required re-hospitalisation
    o Number of COPD-related deaths
    2. Change in CRQ from Baseline at Day 14 and Weeks 8, 12 and 26 to evaluate recovery, comparing among the three groups over time
    3. Cumulative oral/IV steroid dose from Day 1 to Day 14, and from Day 14 to Week 26
    4. Change in inflammatory blood biomarkers (IL-6, TNF-α, fibrinogen, hs-CRP, and MPO) daily during Part 1 of the study, and at Weeks 8, 12 and 26
    5. Relationship between BCT197 exposure and efficacy/safety endpoints
    6. Change from baseline in mMRC dyspnoea scale over time
    7. BODE index among the three groups at Day 14
    E.5.2.1Timepoint(s) of evaluation of this end point
    Please refer to protocol (Table 9-1 Schedule of Assessments).
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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 trial3
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA61
    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
    Bulgaria
    Czech Republic
    Germany
    Hungary
    Italy
    Latvia
    Poland
    Romania
    Russian Federation
    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
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    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 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 108
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 162
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 186
    F.4.2.2In the whole clinical trial 270
    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)
    None
    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 Decision2016-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-07
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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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