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    Summary
    EudraCT Number:2018-002526-23
    Sponsor's Protocol Code Number:CS2514-2017-0004
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-05-22
    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 ConcernedGreece - EOF
    A.2EudraCT number2018-002526-23
    A.3Full title of the trial
    A Randomized, Active-Controlled Study to Evaluate the Efficacy and Safety of Intravenous Sulbactam-ETX2514 in the Treatment of Patients With Infections Caused by Acinetobacter baumannii-calcoaceticus Complex
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to Evaluate the Efficacy and Safety of Sulbactam-ETX2514, a New Drug in the Treatment of Patients With ABC Infections Caused by Acinetobacter baumannii-calcoaceticus Complex
    A.4.1Sponsor's protocol code numberCS2514-2017-0004
    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 SponsorEntasis Therapeutics
    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 supportEntasis Therapeutics
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHarald Hoelzl
    B.5.2Functional name of contact pointClinical Trial Manager
    B.5.3 Address:
    B.5.3.1Street AddressTheresienhöhe 30
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code80339
    B.5.3.4CountryGermany
    B.5.4Telephone number+4989895 571 899
    B.5.6E-mailregsubmissions@medpace.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 nameETX2514
    D.3.2Product code ETX2514 Sodium, NaETX2514
    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 INNNone
    D.3.9.1CAS number 1467157-21-6
    D.3.9.2Current sponsor codeETX2514
    D.3.9.3Other descriptive nameETX2514 Sodium, NaETX2514
    D.3.9.4EV Substance CodeSUB190240
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The 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 nameSulbactam
    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 INNSulbactam Sodium
    D.3.9.1CAS number 69388-84-7
    D.3.9.2Current sponsor codeSulbactam
    D.3.9.3Other descriptive nameSULBACTAM SODIUM
    D.3.9.4EV Substance CodeSUB04617MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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 Imipenem/Cilastatin Kabi 500 mg/500 mg Fresenius Kabi
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi Deutschland 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.3.1Product nameImipenem/Cilastatin
    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 INNImipenem
    D.3.9.1CAS number 74431-23-5
    D.3.9.2Current sponsor codeImipenem
    D.3.9.3Other descriptive nameIMIPENEM
    D.3.9.4EV Substance CodeSUB21472
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCilastatin
    D.3.9.1CAS number 82009-34-5
    D.3.9.2Current sponsor codeCilastatin
    D.3.9.3Other descriptive nameCILASTATIN SODIUM
    D.3.9.4EV Substance CodeSUB01295MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 COLOMYCIN INJECTION 2 million IU/vial
    D.2.1.1.2Name of the Marketing Authorisation holderForest Laboratories 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.3.1Product nameColistin
    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 INNCOLISTIMETHATE SODIUM
    D.3.9.1CAS number 2680-63-9
    D.3.9.2Current sponsor codeColistin
    D.3.9.4EV Substance CodeSUB01430MIG
    D.3.10 Strength
    D.3.10.1Concentration unit million IU million international units
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    Infections Caused by Acinetobacter baumannii-calcoaceticus Complex
    E.1.1.1Medical condition in easily understood language
    Infections Caused by Acinetobacter baumannii-calcoaceticus Complex
    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 10003999
    E.1.2Term Bacteremia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10046577
    E.1.2Term Urinary tract infections
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10037597
    E.1.2Term Pyelonephritis acute
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076918
    E.1.2Term Hospital acquired pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10065153
    E.1.2Term Ventilator associated pneumonia
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10078408
    E.1.2Term Surgical site infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •To compare the efficacy of ETX2514SUL plus imipenem/cilastatin to colistin plus imipenem/cilastatin in patients with carbapenem-resistant ABC (CRABC) infections in Part A;
    •To compare the incidence of nephrotoxicity, as measured by the Risk–Injury–Failure–Loss–End stage renal disease (RIFLE) criteria, of ETX2514SUL to colistin in patients with ABC infections in Part A.
    E.2.2Secondary objectives of the trial
    •To compare the efficacy of ETX2514SUL plus imipenem/cilastatin to colistin plus imipenem/cilastatin in all randomized patients in Part A;
    •To evaluate the efficacy of ETX2514SUL plus imipenem/cilastatin in patients with colistin resistant ABC infections in Part B;
    •To estimate the efficacy of ETX2514SUL plus imipenem/cilastatin for each primary infection site;
    •To evaluate and compare the safety of ETX2514SUL and colistin;
    •To describe the overall safety profile of ETX2514SUL;
    •To determine the systemic exposure of ETX2514 and sulbactam in a small cohort of severely ill patients administered ETX2514SUL in Part A.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Inclusion Criteria for Part A and B:
    1. A signed informed consent form. If a study patient is unable to provide informed consent due to their medical condition, the patient’s legally authorized representative may consent on behalf of the study patient, as permitted by local law and institutional Standard Operating Procedures;
    2. Male or female 18 years of age or older;
    3. A confirmed diagnosis of a serious infection and the expectation, in the judgment of the Investigator, that the patient’s infection will require treatment with intravenous (IV) antibiotics;
    4. A known infection caused by ABC (bacteremia, HABP, VABP, complicated urinary tract infection [cUTI] or acute pyelonephritis [AP], or surgical or post traumatic wound infections) as either a single pathogen or member of a polymicrobial infection based on evidence from culture or, if available, rapid diagnostic test from a sample collected within 72 hours prior to randomization (HABP/VABP patients), AND 1 of the following:
    a. Has received no more than 48 hours of effective empiric therapy prior to enrollment; OR
    b. Is clinically failing prior treatment regimens (ie, clinical deterioration or failure to improve after at least 48 hours of antibiotic treatment);
    Note: Rapid testing of respiratory specimens utilizing Biofire® FilmArray® 2.0 Pneumonia Panel (BPP) technology may be used to enable early identification of ABC pneumonia. Patients can be randomized based on the results of the BPP rapid test while awaiting results of cultures from the local laboratory. However, if the respiratory sample does not grow ABC in the local microbiology laboratory culture, these patients will be withdrawn from the study drug treatment.
    5. Expectation, in the judgment of the Investigator, that the patient will survive at least 72 hours with effective antibiotic therapy and appropriate supportive care for the anticipated duration of the study;
    6. Women of childbearing potential (ie, not post-menopausal or surgically sterilized) must have a negative serum pregnancy test before randomization. Participating women of childbearing potential must be willing to consistently use 2 highly effective methods of contraception (ie, condom, combined oral contraceptive, implant, injectable, indwelling intrauterine device, or a vasectomized partner) from Screening until at least 30 days after administration of the last dose of study drug; and
    7. Male participants must be willing to use condoms during sexual intercourse from Screening until at least 90 days after administration of the last dose of study drug.
    E.4Principal exclusion criteria
    1. Presence of suspected or confirmed deep-seated infection, including lung abscess in patients with pneumonia, that is not planned on being drained within 24 hours after randomization;
    2. Evidence of active concurrent community-acquired pneumonia caused by e.g. Streptococcus pneumoniae, Haemophilus influenzae, etc;
    3. Presence of suspected or confirmed osteomyelitis, endocarditis, or meningitis, as determined by history and/or physical examination;
    4. Irremovable implantable device or line thought to be the potential source of infection;
    5. Sustained shock with persisting hypotension requiring vasopressors to maintain mean arterial pressure (MAP) higher or equal to 60 mmHg AND having a serum lactate >2 mmol/L (18 mg/dL) despite adequate volume resuscitation;
    6. For patients to be enrolled with the primary indication of HABP or VABP, any of the following conditions:
    a. Diagnosis of ventilator-associated tracheobronchitis; or
    b. Inability to provide proper respiratory specimens for culture. Respiratory samples from expectorated or induced sputum should show <10 squamous epithelial cells and >25 polymorphonuclear neutrophils per 100 field;
    7. For patients to be enrolled with the primary indication of cUTI or AP, any of the following urologic conditions:
    a. Likely to receive ongoing antibacterial drug prophylaxis after treatment of cUTI (eg, patients with vesico-uretal reflux);
    b. Suspected or confirmed prostatitis;
    c. Requirement for bladder irrigation with antibiotics or for antibiotics to be administered directly via urinary catheter;
    d. Previous or planned cystectomy or ileal loop surgery;
    e. Uncomplicated urinary tract infection (eg, female patients with urinary frequency, urgency, or pain or discomfort without systemic symptoms or signs of infection);
    f. Complete, permanent obstruction of the urinary tract;
    g. Suspected or confirmed perinephric or renal corticomedullary abscess;
    h. Polycystic kidney disease; or
    i. Any recent history of trauma to the pelvis or urinary tract;
    8. Moribund patients or patients with evidence of immediately life-threatening disease where, in the opinion of the Investigator, the patient is unlikely to survive more than 72 hours after Day 1;
    9. Pregnant or breastfeeding women;
    10. APACHE II score >30 at the time of diagnosis of infection;
    11. Receiving chronic hemodialysis or peritoneal dialysis;
    12. Known seizure disorder requiring current treatment with antiseizure medication that, in the opinion of the Investigator, would prohibit the patient from complying with the protocol.
    13. Requirement for continuing treatment with probenecid, methotrexate, ganciclovir, valproic acid, or divalproex sodium during the study;
    14. Evidence of significant hepatic disease or dysfunction,
    15. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >3 upper limit of normal (ULN) AND total bilirubin >2 ULN at Screening;
    16. Requirement at the time of randomization for any reason, or likely to require during the patient’s participation in the study (from randomization through the Late Follow-up [LFU] Visit), for additional systemic antimicrobial therapy (including Gram negative antibacterial, antiviral, antimycobacterial, or antifungal therapy) other than study drug, with the exception of a single oral dose of any antifungal treatment for vaginal candidiasis;
    17. Requirement for inhaled antibiotics;
    18. Known history of human immunodeficiency virus infection and known recent CD4 count <200/mm3 within the last year or presence of significant immunologic disease or dysfunction;
    19. Presence of neutropenia (absolute neutrophil count <500/mm3) obtained from a local laboratory at Screening;
    20. A QT interval corrected using Fridericia’s formula higher or equal to 80 msec;
    21. History of significant hypersensitivity or allergic reaction to any β-lactam (BL), any contraindication to the use of cilastatin based on local approved prescribing information, any contraindication to the excipients used in the respective formulations, or any contraindication to the use of BL antibiotics;
    22. Participation in a clinical study within the last 30 days or 5 half-lives, whichever is longer, prior to Day 1;
    23. Any condition that would compromise the safety of the patient or the quality of the data or require greater than 14 days of treatment with antibiotics;
    24. Unable or unwilling to comply with the protocol;
    25. Has previously received study drug in this study.
    E.5 End points
    E.5.1Primary end point(s)
    28-day all-cause mortality in the CRABC m-MITT Population in Part A.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 5, Day 7, EOT, TOC, and LFU Visits.
    E.5.2Secondary end point(s)
    •28-day all-cause mortality in the ITT Population;
    •Attributable mortality in the CRABC m-MITT Population, if, at the discretion of the Investigator, the death is related to the indication infection (ie, ABC);
    •Clinical cure at TOC in the CRABC m-MITT Population;
    •Clinical cure at TOC in the m-MITT, Clinical Evaluable (CE), Microbiologic Evaluable (ME), and CRABC ME Populations;
    •Clinical cure at Day 5, Day 7, EOT, and LFU in the m-MITT, CRABC m MITT, CE, ME, and CRABC ME Populations;
    •Microbiological favorable assessment at Day 5, Day 7, EOT, TOC, and LFU in the m-MITT, CRABC m-MITT, ME, and CRABC ME Populations;
    •14-day all-cause mortality in the CRABC m-MITT and m-MITT Populations;
    •28-day all-cause mortality in the m-MITT and CRABC ME Populations; and
    •PK exposure of ETX2514 and sulbactam in the PK Population.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days
    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) 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 Yes
    E.8.1.4Double blind No
    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
    Part A: Assessor and Sponsor blinded; Part B: open-label non randomised
    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 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 EEA22
    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
    Belarus
    Brazil
    China
    Greece
    Hungary
    India
    Israel
    Italy
    Korea, Democratic People's Republic of
    Lithuania
    Mexico
    Peru
    Russian Federation
    Spain
    Taiwan
    Thailand
    Turkey
    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
    End of Study in this study is defined as the last visit or last study-related contact (whichever comes last) of the last patient worldwide.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 248
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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
    Unconscious patients due to medical condition
    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 52
    F.4.2.2In the whole clinical trial 246
    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 Decision2019-07-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-26
    P. End of Trial
    P.End of Trial StatusOngoing
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