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    Summary
    EudraCT Number:2016-004153-32
    Sponsor's Protocol Code Number:MK-7625A-034
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-06-21
    Trial 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 ConcernedGreece - EOF
    A.2EudraCT number2016-004153-32
    A.3Full title of the trial
    A Phase 2, Randomized, Active Comparator-Controlled, Multicenter, Double-Blind Clinical Trial to Study the Safety and Efficacy of Ceftolozane/Tazobactam (MK-7625A) Versus Meropenem in Pediatric Subjects with Complicated Urinary Tract Infection, Including Pyelonephritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ceftolozane/tazobactam (MK-7625A) versus Meropenem in Pediatric Complicated Urinary Tract Infection
    A.3.2Name or abbreviated title of the trial where available
    Ceftolozane/tazobactam (MK-7625A) versus Meropenem in Pediatric cUTI
    A.4.1Sponsor's protocol code numberMK-7625A-034
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/088/2017
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., 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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.5.2Functional name of contact pointGlobal Clinical Trials Operations
    B.5.3 Address:
    B.5.3.1Street AddressOne Merck Drive PO Box 100
    B.5.3.2Town/ cityWhitehouse Station
    B.5.3.3Post code08889-0100
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1267305 3540
    B.5.5Fax number+1267305 6545
    B.5.6E-mailmatthew.johnson1@merck.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Zerbaxa
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNceftolozane
    D.3.9.1CAS number 936111-69-2
    D.3.9.2Current sponsor codeMK7625A
    D.3.9.3Other descriptive nameCEFTOLOZANE SULFATE
    D.3.9.4EV Substance CodeSUB167761
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTazobactam
    D.3.9.1CAS number 89785-84-2
    D.3.9.2Current sponsor codeMK7625A
    D.3.9.3Other descriptive nameTAZOBACTAM SODIUM
    D.3.9.4EV Substance CodeSUB04682MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 MERREM IV
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMEROPENEM
    D.3.9.1CAS number 96036-03-2
    D.3.9.3Other descriptive nameMEROPENEM ANHYDROUS
    D.3.9.4EV Substance CodeSUB49628
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 RoleComparator
    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 MERREM IV
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMEROPENEM
    D.3.9.1CAS number 96036-03-2
    D.3.9.3Other descriptive nameMEROPENEM ANHYDROUS
    D.3.9.4EV Substance CodeSUB49628
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Meronem IV
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Powder and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMeropenem
    D.3.9.1CAS number 119478-56-7
    D.3.9.3Other descriptive nameMEROPENEM TRIHYDRATE
    D.3.9.4EV Substance CodeSUB21617
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of complicated urinary tract infection (cUTI), including pyelonephritis
    E.1.1.1Medical condition in easily understood language
    Complicated Urinary Tract Infection
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10037606
    E.1.2Term Pyelonephritis, unspecified
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046576
    E.1.2Term Urinary tract infection, site not specified
    E.1.2System Organ Class 100000004862
    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 safety and tolerability of ceftolozane/tazobactam compared with that of meropenem
    E.2.2Secondary objectives of the trial
    1. To evaluate the efficacy of ceftolozane/tazobactam compared with that of meropenem with respect to clinical response at the End of Treatment (EOT) and Test of Cure (TOC) Visits
    2. To evaluate the efficacy of ceftolozane/tazobactam compared with that of meropenem with respect to per-subject microbiological response at the EOT and TOC Visits
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have a legal representative who provides written informed consent for the trial on the subject’s behalf and provides age-appropriate written informed assent (as applicable) for the trial
    2.Be a male or female from birth (defined as >32 weeks gestational age and ≥7 days postnatal) to <18 years of age
    3.Be able to comply with the protocol for the duration of the trial
    4.Require IV antibacterial therapy for the treatment of cUTI
    5.Have a pretreatment baseline urine culture specimen obtained within 48 hours before the start of administration of the first dose of study treatment and preferably prior to administration of any potentially therapeutic antibiotics. Specimen is to be obtained by suprapubic aspiration, clean intermittent urethral catheterization, indwelling urethral catheter, or midstream clean catch
    6.Have pyuria, defined as dipstick analysis positive for leukocyte esterase, OR: a)If ≥1 year of age: White blood cell (WBC) count >10 cells/μL in unspun urine or ≥10 cells/high power field in spun urine b)If <1 year of age: WBC count >5 cells/μL in unspun urine or ≥5 cells/high power field in spun urine
    7.Have clinical signs and/or symptoms of cUTI (pyelonephritis or cLUTI) at the Screening Visit as described in the protocol
    8.Meet one of the following categories: a)The subject is a male who is not of reproductive potential, defined as a male who has azoospermia (whether due to being prepubertal, having had a vasectomy, or an underlying medical condition) b)The subject is a female who is not of reproductive potential, defined as a female who either: (1) Has not undergone menarche; (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening, or (3) has a congenital or acquired condition that prevents childbearing
    c)The subject is a female or a male of reproductive potential who agrees to avoid becoming pregnant or impregnating partner during screening, while receiving study treatment, and for at least 30 days after the last dose of study treatment by complying with one of the following: (1) Practice abstinencea from heterosexual activity OR (2) use (or have their partner use) acceptable contraception during heterosexual activity. Refer to the protocol for the acceptable methods of contraception
    9.Meet the following criteria for a female subject who is of reproductive potential: a)The subject is not pregnant (as confirmed by serum pregnancy test at screening) and not planning to become pregnant within 30 days of the last day of study treatment administration b)The subject is nonlactating
    E.4Principal exclusion criteria
    1.Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days prior to the first dose of study treatment in this current trial
    2.Has previously participated in any trial of ceftolozane or ceftolozane/tazobactam or has enrolled previously in the current trial and been discontinued
    3.Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that, in the opinion of the investigator, might expose the subject to increased risk by participating in the trial, confound the results of the trial, or interfere with the subject’s participation for the full duration of the trial
    4.Has a history of any moderate or severe hypersensitivity (eg, anaphylaxis), allergic reaction, or other contraindication to any of the following: β-lactam antibiotics (eg, penicillins, cephalosporins and carbapenems), or β-lactamase inhibitors (eg, tazobactam, sulbactam, clavulanic acid, avibactam)
    5.Has a history of a cUTI within the past 1 year prior to randomization that is caused by a pathogen known to be resistant to either IV study treatment
    6.Has a concomitant infection at the time of randomization that requires nonstudy systemic antibacterial therapy in addition to IV study treatment or oral step -down therapy (medications with only gram-positive activity [eg, vancomycin, linezolid] are allowed)
    7.Has received potentially therapeutic antibacterial therapy (eg, with gram negative activity), including bladder infusions with topical urinary antiseptics or antibacterial agents, for a duration of more than 24 hours during the 48 hours preceding the first dose of study treatment
    8.Has any of the following: a)Intractable UTI or pyelonephritis infection at baseline that the Investigator anticipates would require more than 14 days of study treatment b)Confirmed fungal urinary tract infection at time of randomization with ≥103 fungal CFU/mL c)Permanent indwelling bladder catheter or instrumentation including nephrostomy d)Current urinary catheter that is not scheduled to be removed before the end of all study treatment (intermittent straight catheterization during the study treatment period is acceptable) e)Complete, permanent obstruction of the urinary tract f)Suspected or confirmed perinephric or intrarenal abscess g)Documented ileal loop reflux h) Suspected or confirmed prostatitis, urethritis, or epididymitis i)Trauma to pelvis/urinary tract
    9.Has a moderate or severe impairment of renal function, defined as an estimated creatinine clearance (CrCL) <50 mL/min/1.73 m2 based on the Schwartz equation [23] or requirement for peritoneal dialysis, hemodialysis, or hemofiltration
    10.Has one or more of the following laboratory abnormalities in a specimen obtained at baseline: a)Absolute neutrophil count (ANC) <1000/mm3 b)Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 × the upper limit of normal (ULN) c)Total bilirubin ≥2 × ULN (if 7 to ≤28 days of age and breastfeeding, total bilirubin >10 mg/dL OR ≥2 × ULN)
    11.Has a seizure disorder or is anticipated to be treated with divalproex sodium or valproic acid during the course of study treatment
    12.Is receiving, or is expected to receive, any of the following
    medications:
    a) Immunosuppressive agents
    b) Valproic acid or divalproex sodium
    c) Probenecid
    13.Has any rapidly progressing disease or immediately life-threatening
    illness including acute hepatic failure, respiratory failure, or septic shock
    14.Has an immunocompromising condition, including established AIDS,
    hematological malignancy, or bone marrow transplantation, or
    immunosuppressive therapy including cancer chemotherapy,
    medications for prevention of organ transplantation rejection, or the
    administration of corticosteroids equivalent to or greater than the
    systemic equivalent of ≥2 mg/kg total daily dose of prednisone for more
    than 14 days in the 30 days preceding randomization
    15.Has a history of malignancy ≤5 years prior to signing informed
    consent, except for adequately treated basal cell or squamous cell skin
    cancer or in situ cervical cancer
    16.Planned receipt of suppressive/prophylactic antibiotics with gramnegative
    activity after completion of study treatment
    17.Is or has an immediate family member (e.g., spouse, parent/legal
    guardian, sibling or child) who is investigational site or Sponsor staff
    directly involved with this trial
    E.5 End points
    E.5.1Primary end point(s)
    1. Adverse events (AEs)
    2. Clinical laboratory tests
    3. Vital signs
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety evaluation all study visits
    E.5.2Secondary end point(s)
    1. Clinical success at the End of Treatment (EOT) and Test of Cure (TOC) Visits
    2. Per-subject microbiological eradication at the EOT and TOC Visits

    E.5.2.1Timepoint(s) of evaluation of this end point
    End of IV Treatment (EOIV), End of treatment (EOT), Test of cure (TOC)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 Yes
    E.8.1.7.1Other trial design description
    open label Oral step down therapy / Standard of Care
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA21
    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
    Greece
    Hungary
    Mexico
    Poland
    Romania
    Russian Federation
    South Africa
    Turkey
    Ukraine
    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 years3
    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 years3
    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: 120
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 1
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 2
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 22
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 65
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception 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
    Pediatric patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 63
    F.4.2.2In the whole clinical trial 120
    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 Decision2017-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-01
    P. End of Trial
    P.End of Trial StatusCompleted
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