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    Summary
    EudraCT Number:2014-000546-30
    Sponsor's Protocol Code Number:Rempex-506
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-10-30
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-000546-30
    A.3Full title of the trial
    A PHASE 3, MULTI-CENTER, RANDOMIZED, OPEN-LABEL STUDY OF CARBAVANCE (MEROPENEM/RPX7009) VERSUS BEST AVAILABLE THERAPY IN SUBJECTS WITH SELECTED SERIOUS INFECTIONS DUE TO CARBAPENEM RESISTANT ENTEROBACTERIACEAE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized open-lable Phase 3 study performed at multiple study sites to evaluate the safety, efficacy and tolerability of the combinational product Carbavance (Meropenem/RPX7009) in comparison to best available therapy to treat patients with selected serious urinary infections, bacterial pneumonia infections and/or blood infections known or suspected to be caused by carbapenem-resistant Enterobacteriaceae.
    A.4.1Sponsor's protocol code numberRempex-506
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02168946
    A.5.4Other Identifiers
    Name:US-IND # Number:120040
    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 SponsorRempex Pharmaceuticals, 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 supportRempex Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportBiomedical Advanced Research and Development Authority (BARDA)
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRempex Pharmaceuticals Inc.
    B.5.2Functional name of contact pointElizabeth Morgan
    B.5.3 Address:
    B.5.3.1Street Address8 Sylvan Way
    B.5.3.2Town/ cityParsippany, NY
    B.5.3.3Post code07054
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18588756671
    B.5.5Fax number+18588752851
    B.5.6E-mailliz.morgan@themedco.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 nameCarbavance
    D.3.2Product code Meropenem/RPX7009
    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 119478-56-7
    D.3.9.2Current sponsor codeMeropenem
    D.3.9.3Other descriptive nameMEROPENEM TRIHYDRATE
    D.3.9.4EV Substance CodeSUB21617
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 1360457-46-0
    D.3.9.2Current sponsor codeRPX7009
    D.3.9.3Other descriptive nameMP7009, REBO-07, MP7
    D.3.9.4EV Substance CodeSUB167957
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    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.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.2.5The 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 nameBest Available Treatment
    D.3.2Product code BAT
    D.3.4Pharmaceutical form
    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.3.9.2Current sponsor code.
    D.3.9.3Other descriptive nameMEROPENEM
    D.3.9.4EV Substance CodeSUB08778MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNERTAPENEM
    D.3.9.1CAS number .
    D.3.9.2Current sponsor code.
    D.3.9.3Other descriptive nameERTAPENEM
    D.3.9.4EV Substance CodeSUB25388
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIMIPENEM
    D.3.9.1CAS number 64221-86-9
    D.3.9.4EV Substance CodeSUB08151MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTIGECYCLINE
    D.3.9.1CAS number 220620-09-7
    D.3.9.4EV Substance CodeSUB16467MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOLISTIN
    D.3.9.1CAS number 1066-17-7
    D.3.9.4EV Substance CodeSUB01429MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMIKACIN
    D.3.9.1CAS number 37517-28-5
    D.3.9.4EV Substance CodeSUB05431MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTOBRAMYCIN
    D.3.9.3Other descriptive nameTOBRAMYCIN
    D.3.9.4EV Substance CodeSUB11134MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGENTAMICIN
    D.3.9.3Other descriptive nameGENTAMICIN
    D.3.9.4EV Substance CodeSUB02326MIG
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPOLYMYXIN B
    D.3.9.3Other descriptive namePOLYMYXIN B
    D.3.9.4EV Substance CodeSUB03937MIG
    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) Yes
    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
    serious infections, specifically complicated urinary tract infection (cUTI) or acute pyelonephritis (AP), hospital acquired bacterial pneumonia (HABP), ventilator associated bacterial pneumonia (VABP), and/or bacteremia, known or suspected to be caused by carbapenem-resistant Enterobacteriaceae (CRE)
    E.1.1.1Medical condition in easily understood language
    serious urinary infections, bacterial pneumonia infections and/or blood infections known or suspected to be caused by carbapenem-resistant Enterobacteriaceae
    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 17.1
    E.1.2Level LLT
    E.1.2Classification code 10003999
    E.1.2Term Bacteremia
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10001032
    E.1.2Term Acute pyelonephritis
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10004051
    E.1.2Term Bacterial pneumonia, unspecified
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level HLT
    E.1.2Classification code 10046577
    E.1.2Term Urinary tract infections
    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, tolerability and efficacy of Carbavance™ (meropenem/RPX7009) in treatment of subjects with selected serious infections, suspected or known to be due to CRE; and
    To assess the pharmacokinetics (PK) of meropenem and RPX7009 in subjects with selected serious infections, suspected or known to be due to CRE.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Willingness to comply with all study activities and procedures and to provide signed, written informed consent prior to any study procedures. If a subject is unable to provide informed consent due to their medical condition, the subject’s legal representative will be provided with study information in order for consent to be obtained.
    2.Hospitalized male or female, >18 years of age.
    3.Weight >150 kg.
    4.Have a confirmed diagnosis of a serious infection, specifically cUTI or AP, HABP, VABP, and/or bacteremia, requiring administration of IV antibacterial therapy (See inclusion number 7 for criteria for all indications).
    5.The following must be satisfied:
    For known CRE infection:
    -Have a known CRE infection based on evidence from CRE culture or other phenotypic or molecular testing within 72 hours prior to Day 1, alone or as a single isolate of a polymicrobial infection;
    -Have received no more than 24 hours of a potentially effective (i.e., gram negative coverage) antimicrobial therapy prior to enrollment,
    OR
    -Have documented clinical evidence of failure (i.e., clinical deterioration or failure to improve) while on a potentially effective regimen.
    For suspected CRE infection:
    -Have a suspected CRE infection based on evidence from CRE culture (KPC producing) or other phenotypic or molecular testing, alone or as a single isolate of a polymicrobial infection, from any source within 90 days prior to Day 1;
    -Have received no more than 24 hours of a potentially effective (i.e., gram negative coverage) antimicrobial therapy prior to enrollment,
    OR
    -Have documented clinical evidence of failure (i.e., clinical deterioration or failure to improve) while on a potentially effective regimen.
    6.Expectation, in the opinion of the Investigator, that the subject’s infection will require treatment with IV antibiotics for a minimum of 7 days.
    7.Diagnosis with either cUTI or AP, HABP, VABP, and/or bacteremia as defined per protocol.
    8.Female subjects of child-bearing potential, including those who are less than 2 years post-menopausal, must agree to, and comply with, using 2 highly effective methods of birth control (i.e., condom plus spermicide, combined oral contraceptive, implant, injectable, indwelling intrauterine device, sexual abstinence, or a vasectomized partner) while participating in this study. In addition, all women of childbearing potential must agree to continue to use 2 forms of birth control throughout the study and for at least 30 days after administration of the last dose of study drug.
    E.4Principal exclusion criteria
    1.History of any significant hypersensitivity or severe allergic reaction to any beta lactam antibiotics (e.g., cephalosporins, penicillins, carbapenems, or monobactams).
    2.Known or suspected likely infection with New Delhi metallo- (NDM), Verona integron encoded metallo- (VIM), or IMP-metallo-beta-lactamases or oxacillinase- (OXA) beta lactamases (i.e., Class B or Class D beta lactamases).
    3.For subjects to be enrolled with the primary indication of cUTI or AP, any of the following urologic conditions:
    Likely to receive ongoing antibacterial drug prophylaxis after treatment of cUTI (e.g., subjects with vesico-ureteral reflux);
    Suspected or confirmed prostatitis;
    Requirement for bladder irrigation with antibiotics or for antibiotics to be administered directly via urinary catheter;
    Previous or planned cystectomy or ileal loop surgery;
    Uncomplicated urinary tract infection (for example, female subjects with urinary frequency, urgency or pain or discomfort without systemic symptoms or signs of infection);
    Complete, permanent obstruction of the urinary tract;
    Suspected or confirmed perinephric or renal corticomedullary abscess; or Polycystic kidney disease.
    4.For subjects to be enrolled with the primary indication of HABP or VABP, any of the following conditions:
    Diagnosis of ventilator-associated tracheobronchitis
    Inability to obtain proper respiratory specimens for culture
    5.For subjects to be enrolled with the indication of bacteremia unrelated to cUTI or AP, HABP, and VABP, any of the following:
    Unverified CRE infection
    Source of infection thought to be related to or involving a non removable or implantable device or line.
    6.Impairment of renal function including a calculated creatinine clearance of <20 mL/min (Cockcroft-Gault), requirement for peritoneal dialysis, hemodialysis or hemofiltration, or oliguria (<20 mL urine output per hour over 24 hours).
    7.Evidence of immediately life-threatening disease, including, but not limited to, acute heart failure, shock, acute coronary syndrome, unstable arrhythmias, hypertensive emergency, acute hepatic failure, active gastrointestinal bleeding, profound metabolic abnormalities (e.g., diabetic ketoacidosis), or acute cerebrovascular events, OR in the opinion of the Investigator, the subject is unlikely to survive the duration of the treatment.
    8.Myasthenia gravis, Parkinsonism, or other neuromuscular disorder.
    9.Acute Physiology and Chronic Health Evaluation (APACHE) II score >30. An APACHE II score is only required if calculated.
    10.Known or suspected endocarditis, meningitis, intra-abdominal infection, or osteomyelitis.
    11.Unremovable or implantable device or line thought to be the potential source of infection.
    12.Evidence of significant hepatic, hematological, or immunologic disease or dysfunction determined by any of the following:
    Known acute viral hepatitis;
    Aspartate aminotransferase or alanine aminotransferase level >5 × upper limit of normal (ULN) or total bilirubin >3 × ULN;
    Manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy;
    Current or anticipated neutropenia defined as <500 neutrophils/mm3;
    Thrombocytopenia with platelet count <60,000 cells/mm3;
    Human immunodeficiency virus with either a CD4 count <200 cells/mm3 at the last measurement, or current diagnosis of another Acquired Immune Deficiency Syndrome-defining illness;
    Bone marrow-ablative chemotherapy or radiation therapy within the prior 3 months; or Requiring chronic treatment of >20 mg of prednisone (or equivalent systemic corticosteroid) per day for over 2 weeks.
    13.Past or current history of epilepsy or seizure disorder requiring current treatment with anti-seizure medications.
    14.Ongoing receipt of sodium valproate or probenecid.
    15.Women who are pregnant or breastfeeding.
    16.Require the use of inhaled antibiotics.
    17.Participation in any study involving administration of an investigational agent or device within 30 days prior to randomization into this study or previous participation in the current study.
    18.Previous participation in a study of RPX7009.
    19.Any condition that, in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for cUTI or Ap is the proportion of subjects in the mCRE-MITT who demonstrate Microbiological eradication; Population who demonstrate a response of Overall Success at the TOC visit.
    A response of overall success is defined asachieved in a subject whose gram-negative antimicrobial therapy to treat the baseline infection is not altered (other than dose adjustment or modification of Best Available Therapy based on susceptibility of baseline pathogen within the first 72 hours after first dose of study drug) after randomization due to concerns of microbiological failure, clinical failure, or tolerability AND at TOC per protocol.

    Primary Endpoint for HABP and VABP
    The all-cause mortality rate in the mCRE-MITT and m-MITT Populations at Day 28 for all patients with HABP, VABP, and bacteremia (not related to cUTI/AP or HABP/VABP;

    Primary Endpoint for Bacteremia
    The all-cause mortality rate in the mCRE-MITT Population at Day 28 for all patients with HABP, VABP, and bacteremia (not related to cUTI/AP or HABP/VABP;
    E.5.1.1Timepoint(s) of evaluation of this end point
    LPLV as per details listed in above section.
    E.5.2Secondary end point(s)
    Secondary Endpoints for cUTI or AP
    - The all-cause mortality rate in the mCRE-MITT and m-MITT Populations at Day 28;
    - Proportion of subjects in the m MITT and ME Populations who demonstrate a response of overall success at the TOC visit;
    - Proportion of subjects in the mCRE-MITT, m MITT, CE, CRE-ME, and ME Populations with a clinical outcome of cure at Day 3, EOT, TOC, and LFU;
    - Proportion of subjects in the mCRE-MITT, m MITT, CE, CRE-ME, and ME Populations with a clinical outcome of cure at TOC, where the use of an aminoglycoside beyond 72 hours in subjects with a pathogen susceptible to Carbavance (meropenem/RPX7009) is assigned to failure;
    - Proportion of subjects in the mCRE-MITT, m MITT, CRE-ME, and ME Populations with a microbiological outcome of eradication at Day 3, EOT, TOC, and LFU;
    Relapse/recurrence rates of baseline cUTI or AP at the LFU visit; and
    - Per-pathogen outcome in the mCRE-MITT, m-MITT, CRE-ME, and ME Populations at Day 3, EOT, TOC, and LFU.

    Secondary Endpoints for HABP and VABP
    - The all-cause mortality rate in the mCRE-MITT and m-MITT Populations at Day 28
    - The proportion of subjects in the mCRE-MITT Population who demonstrate a response of Success cure at the TOC visit;.
    A clinical outcome of cure is defined as a subject whose gram-negative antimicrobial therapy to treat the baseline infection is not altered (other than dose adjustment or modification of Best Available Therapy based on susceptibility of baseline pathogen within the first 72 hours after first dose of study drug) after randomization due to concerns of microbiological failure, clinical failure, or tolerability AND at TOC per protocol.
    - Proportion of subjects in the mCRE-MITT, m MITT, CE, CRE-ME, and ME Populations with a clinical outcome of cure at Day 3, EOT, TOC, and LFU;
    - Proportion of subjects in the mCRE-MITT, m MITT, CE, CRE-ME, and ME Populations with a clinical outcome of cure at TOC, where the use of an aminoglycoside beyond 72 hours in subjects with a pathogen susceptible to Carbavance (meropenem/RPX7009) is assigned to failure;
    -Per-pathogen outcome in the mCRE-MITT, m-MITT, CRE-ME, and ME Populations at Day 3, EOT, TOC, and LFU;
    - Relapse/recurrence rates of baseline bacterial pneumonia at the LFU visit;
    - Total ventilator days measured from time of randomization;
    - Change in the partial pressure arterial oxygen to fraction of inspired oxygen (PaO2:FiO2) ratio from baseline to Day 3, Day 7, and EOT;
    - Time (days) to extubation in subjects who are on the ventilator at baseline (i.e., Day 1).

    Secondary Endpoints for Bacteremia
    - The all-cause mortality rate in the mCRE-MITT and m-MITT Populations at Day 28;
    - The proportion of subjects in the mCRE-MITT Population who demonstrate a response of overall success at the TOC visit.
    A response of Success is defined as a subject whose gram-negative antimicrobial therapy to treat the baseline infection is not altered (other than dose adjustment or modification of Best Available Therapy based on susceptibility of baseline pathogen within the first 72 hours after first dose of study drug) after randomization due to concerns of microbiological failure, clinical failure, or tolerability AND at TOC per protocol;
    - Proportion of subjects in the m-MITT, CRE-ME, and ME Populations who demonstrate a response of overall success at the TOC visit;
    - Proportion of subjects in the mCRE-MITT, m MITT, CE, CRE-ME, and ME Populations with a clinical outcome of cure at Day 3, EOT, TOC, and LFU;
    - Proportion of subjects in the mCRE-MITT, m MITT, CE, CRE-ME, and ME Populations with a clinical outcome of cure at TOC, where the use of an aminoglycoside beyond 72 hours in subjects with a pathogen susceptible to Carbavance (meropenem/RPX7009) is assigned to failure;
    Proportion of subjects in the mCRE-MITT, m-MITT, CRE-ME, and ME Populations with a microbiological outcome of eradication at Day 3, EOT, TOC, and LFU;
    - Relapse/recurrence rates of baseline bacteremia at the LFU visit; and
    - Per-pathogen outcome in the mCRE-MITT, m-MITT, CRE-ME, and ME Populations at Day 3, EOT, TOC, and LFU.
    - Time to bacterial clearance in mCRE-MITT, m-MITT, CRE-ME, and ME Populations
    E.5.2.1Timepoint(s) of evaluation of this end point
    LPLV as per details listed in above section
    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 No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    tolerability
    tolerabilidad
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Best Available Therapy
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Argentina
    Brazil
    Colombia
    Greece
    Israel
    Italy
    Spain
    Taiwan
    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
    LPLV as per the end point criteria
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    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 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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 150
    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)
    The study doctor will discuss future treatment options with the patient,
    if required.
    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 Decision2015-01-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-13
    P. End of Trial
    P.End of Trial StatusOngoing
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