Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44138   clinical trials with a EudraCT protocol, of which   7324   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2018-004704-19
    Sponsor's Protocol Code Number:MK-7625A-036
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Restarted
    Date on which this record was first entered in the EudraCT database:2019-07-04
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-004704-19
    A.3Full title of the trial
    A Phase 1, open-label, non-comparative, multicenter clinical study to evaluate the safety, tolerability, and pharmacokinetics of ceftolozane/tazobactam (MK-7625A) in pediatric participants with nosocomial pneumonia
    Estudio clínico de fase 1, abierto, no comparativo y multicéntrico para evaluar la seguridad, la tolerabilidad y la farmacocinética de ceftolozano/tazobactam (MK-7625A) en participantes pediátricos con neumonía hospitalaria
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and pharmacokinetics of ceftolozane/tazobactam in pediatric participants with nosocomial pneumonia
    seguridad y farmacocinética de ceftolozano/tazobactam en participantes pediátricos con neumonía hospitalaria
    A.4.1Sponsor's protocol code numberMK-7625A-036
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/277/2017
    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 pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28027
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491 3210600
    B.5.5Fax number+3491 3210590
    B.5.6E-mailensayos_clinicos@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.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
    Nosocomial pneumonia
    neumonía hospitalaria
    E.1.1.1Medical condition in easily understood language
    Nosocomial pneumonia
    neumonía hospitalaria
    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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10052596
    E.1.2Term Nosocomial pneumonia
    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 for all participants
    Evaluar la seguridad y la tolerabilidad de ceftolozano/tazobactam en todos los participantes
    E.2.2Secondary objectives of the trial
    To evaluate the pharmacokinetics (PK) of multiple doses of ceftolozane/tazobactam for each age group and/or dose level
    Evaluar la farmacocinética (FC) de dosis repetidas de ceftolozano/tazobactam en cada grupo de edad y/o nivel de dosis.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Has a diagnosis of proven or suspected NP (including HABP or VABP), as determined by the investigator.
    Note: The diagnosis of NP does not require a pathogen to be isolated from a diagnostic test.
    2. Is hospitalized and anticipated to receive a minimum of 8 days of concomitant SOC antibiotic therapy for proven or suspected NP. The concomitant SOC antibiotic therapy can have coverage for either gram positive and/or gram-negative respiratory pathogen(s).
    Note: Concomitant SOC antibiotics may be stopped before the 8-day minimum at the discretion of the investigator. Participants who discontinue or complete concomitant SOC antibiotic therapy in less than 8 days may also discontinue ceftolozane/tazobactam prior to the minimum duration of 8 days at the investigator’s discretion. However, participants are strongly encouraged to receive a minimum of 8 days of ceftolozane/tazobactam.
    Demographics:
    3. Is male or female (not pregnant or nursing) from birth (defined as >32 weeks gestational age and ≥7 days postnatal) to <18 years of age inclusive, at the time of signing the informed consent/assent.
    Male Participants:
    Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    Male participants are eligible to participate if they agree to the following during the intervention period and for at least 30 days after the last dose of study intervention:
    • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent
    OR
    • Must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause ) as detailed below:
    - Agree to use a male condom plus partner use of an additional contraceptive method when having penile-vaginal intercourse with a WOCBP who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must agree to remain abstinent from penile-vaginal intercourse or use a male condom during each episode of penile-vaginal penetration.
    Female Participants:
    Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
    • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
    - Is not a woman of childbearing potential (WOCBP)
    OR
    - Is a WOCBP and using an acceptable contraceptive method or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 30 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
    - A WOCBP must have a negative highly sensitive pregnancy test ([urine or serum] as required by local regulations) within 48 hours before the first dose of study intervention.
    • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
    Informed Consent/Assent:
    4. The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study.
    Additional Categories:
    5. Is able to comply with all study procedures and restrictions for the duration of the study.
    1. Tiene un diagnóstico de NH confirmada o sospechada (incluidas NBAV y NBAH), según lo determinado por el investigador.
    Nota: El diagnóstico de NH no precisa el aislamiento de un patógeno en una prueba diagnóstica.
    2. Está hospitalizado y está previsto que reciba tratamiento antibiótico de referencia concomitante para la NH confirmada o sospechada durante un mínimo de 8 días. El tratamiento antibiótico de referencia concomitante puede tener cobertura frente a patógenos respiratorios grampositivos o gramnegativos.
    Nota: Los antibióticos del TR concomitante podrán suspenderse antes del mínimo de 8 días a criterio del investigador. Los participantes que suspendan o completen el tratamiento antibiótico de referencia concomitante en menos de 8 días podrán suspender también el tratamiento con ceftolozano/tazobactam antes del período mínimo de 8 días.
    Características demográficas
    3. Varón o mujer (no embarazada ni en período de lactancia) desde el nacimiento (definido como > 32 semanas de edad gestacional y ≥ 7 días de período posnatal) hasta < 18 años de edad en el momento de firmar el consentimiento/asentimiento informado.
    Varones participantes
    El uso de anticonceptivos por los varones deberá cumplir la normativa local sobre métodos anticonceptivos para participantes en estudios clínicos.
    Podrán participar en el estudio varones que se comprometan a todo lo siguiente durante el período de intervención y hasta al menos 30 días después de recibir la última dosis de la intervención del estudio:
    - Abstinencia de relaciones heterosexuales como modo de vida habitual y preferido (abstinencia a largo plazo y constante) y compromiso de mantenerla.
    O
    • Uso de métodos anticonceptivos a menos que se confirme la presencia de azoospermia (por vasectomía o secundaria a una causa médica [apéndice 5]) tal como se detalla a continuación:
    - Comprometerse a utilizar preservativo masculino más uso por parte de la pareja de un método anticonceptivo adicional durante las relaciones sexuales con penetración vaginal con mujeres en edad fértil que no estén embarazadas. Nota: Los varones con una pareja embarazada o en período de lactancia deberán comprometerse a mantener la abstinencia de relaciones sexuales con penetración vaginal o a utilizar preservativo masculino durante cada episodio de penetración vaginal.
    Mujeres participantes
    El uso de anticonceptivos por las mujeres deberá cumplir la normativa local sobre métodos anticonceptivos para participantes en estudios clínicos.
    • Una mujer podrá participar si no está embarazada ni en período de lactancia y se cumple al menos una de las condiciones siguientes:
    - No es una mujer en edad fértil (MEF).
    O
    - Es una MEF y utiliza un método anticonceptivo aceptable o practica la abstinencia de relaciones heterosexuales como modo de vida preferido y habitual (abstinencia a largo plazo y constante), según se describe en el apéndice [5], durante el período de intervención y hasta al menos 30 días después de recibir la última dosis de la intervención del estudio. El investigador deberá evaluar la posibilidad de fracaso del método anticonceptivo (es decir, incumplimiento, inicio reciente) antes de la primera dosis de la intervención del estudio.
    - Las MEF deberán dar negativo en una prueba de embarazo de alta sensibilidad (en orina o suero, según exija la normativa local) en las 48 horas previas a la primera dosis de la intervención del estudio.
    • En el apéndice [2] se recogen otros requisitos relacionados con las pruebas de embarazo durante y después de la intervención del estudio.
    • El investigador es responsable de revisar los antecedentes médicos, los antecedentes menstruales y la actividad sexual reciente para reducir el riesgo de inclusión de una mujer con un embarazo inicial no detectado.
    4. El participante (o su representante legal cuando proceda) otorga su consentimiento/asentimiento informado por escrito para el estudio.
    Otras categorías
    5. Es capaz de cumplir todos los procedimientos y restricciones del estudio durante el mismo.
    E.4Principal exclusion criteria
    Medical Conditions:
    1. Has a documented history of any moderate or severe hypersensitivity (or allergic) reaction to any β-lactam antibacterial.
    Note: A history of a rash while on a β-lactam antibiotic does not automatically exclude a participant (eg, a participant with history of a mild rash followed by uneventful re-exposure may be considered for enrollment).
    2. For Groups 1-4, has moderate to severe impairment of renal function, defined as an estimated creatinine clearance (CrCL) <50 mL/min/1.73 m2 based on the revised Schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration.
    For Group 5, has CrCL <20 mL/min/1.73 m2 based on the revised Schwartz equation or requirement for peritoneal dialysis, hemodialysis, or hemofiltration.
    Prior/Concomitant Therapy
    3. Is receiving or is anticipated to receive piperacillin/tazobactam while receiving ceftolozane/tazobactam or has received piperacillin/tazobactam within 24 hours prior to the first dose of ceftolozane/tazobactam.
    Prior/Concurrent Clinical Study Experience
    4. Participation in any clinical study of a therapeutic investigational product within 30 days prior to the first dose of ceftolozane/tazobactam.
    5.Previous participation in any study of ceftolozane or ceftolozane/tazobactam.
    Diagnostic Assessments:
    Not applicable.
    Other Exclusions:
    6. Has one or more of the following laboratory abnormalities in a specimen obtained at screening:
    • Absolute neutrophil count (ANC) <1000/mm3
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥3 × the upper limit of normal (ULN)
    • Total bilirubin ≥2 × the ULN (if 7 to ≤28 days of age and breastfeeding, total bilirubin >10 mg/dL OR ≥2 × ULN).
    7. Any condition or circumstance that, in the opinion of the investigator, would compromise the safety of the participant or the quality of study data.
    8. Has any rapidly progressing disease or immediately life-threatening illness including acute hepatic failure or septic shock.
    9. Has active immunosuppression, including any of the following:
    •human immunodeficiency virus (HIV) infection, with a known CD4 percentage of <15% in pediatric participants ≤5 years of age, or CD4 count of <200 cells/mm3 in pediatric participants >5 years of age
    •active hematological malignancy
    •recipient of solid organ or bone marrow transplants
    •currently on immunosuppressive therapy, including cancer chemotherapy currently on medications for prevention of transplant rejection
    •chronic administration of corticosteroids (defined as >40 mg of prednisone per day administered continuously for more than 14 days prior to the first dose of ceftolozane/tazobactam)
    10. Is or has an immediate family member (eg, parent/legal guardian or sibling) who is investigational site or Sponsor staff directly involved with this study.
    1. Antecedentes documentados de cualquier reacción de hipersensibilidad (o alérgica) moderada o intensa a cualquier antibiótico betalactámico.
    Nota: Los antecedentes de exantema durante el tratamiento con un antibiótico betalactámico no excluyen automáticamente a un participante (por ejemplo, puede considerarse la inclusión de un participante con antecedentes de exantema leve seguido de reexposición sin incidentes).
    2. En los grupos 1-4, presencia de insuficiencia renal grave, definida como un aclaramiento de creatinina (CrCL) estimado < 50 ml/min/1,73 m2 según la ecuación de Schwartz modificada, o necesidad de diálisis peritoneal, hemodiálisis o hemofiltración.
    En el grupo 5, CrCL < 20 ml/min/1,73 m2 según la ecuación de Schwartz modificada o necesidad de diálisis peritoneal, hemodiálisis o hemofiltración
    2. En los grupos 1-4, presencia de insuficiencia renal grave, definida como un aclaramiento de creatinina (CrCL) estimado < 50 ml/min/1,73 m2 según la ecuación de Schwartz modificada, o necesidad de diálisis peritoneal, hemodiálisis o hemofiltración.
    En el grupo 5, CrCL < 20 ml/min/1,73 m2 según la ecuación de Schwartz modificada o necesidad de diálisis peritoneal, hemodiálisis o hemofiltración.
    Tratamiento previo y concomitante
    3. Recibe o se prevé que recibirá piperacilina/tazobactam durante el tratamiento con ceftolozano/tazobactam o ha recibido piperacilina/tazobactam en las 24 horas previas a la primera dosis de ceftolozano/tazobactam.
    Experiencia en estudios clínicos previos o simultáneos
    4. Participación en cualquier estudio clínico de un producto en investigación terapéutico en los 30 días previos a la primera dosis de ceftolozano/tazobactam.
    5. Participación previa en cualquier estudio de ceftolozano o ceftolozano/tazobactam.
    6. Presencia de una o más de las siguientes alteraciones analíticas en una muestra obtenida en la selección:
    • Recuento absoluto de neutrófilos (RAN) < 1000/mm3.
    • Aspartato aminotransferasa (AST) o alanina aminotransferasa (ALT) ≥ 3 × límite superior de la normalidad (LSN).
    • Bilirrubina total ≥ 2 × LSN (en caso de 7 a ≤ 28 días de vida y lactancia materna, bilirrubina total > 10 mg/dl O ≥ 2 × LSN).
    7. Cualquier trastorno o circunstancia que, en opinión del investigador, pueda comprometer la seguridad del participante o la calidad de los datos del estudio.
    8. Presencia de una enfermedad de progresión rápida o que ponga en peligro inmediato la vida, como insuficiencia hepática aguda o shock séptico.
    9. Inmunodepresión activa, incluidos cualquiera de los siguientes:
    • Infección por el virus de la inmunodeficiencia humana (VIH), con un porcentaje conocido de CD4 < 15 % en participantes pediátricos ≤ 5 años de edad, o recuento de CD4 < 200 células/mm3 en pacientes pediátricos > 5 años de edad.
    • Neoplasia hematológica maligna activa.
    • Receptor de trasplante de órgano sólido o de médula ósea.
    • Tratamiento actual con inmunodepresores, incluida quimioterapia antineoplásica.
    • Tratamiento actual para prevenir el rechazo de un trasplante.
    • Administración crónica de corticosteroides (definido como > 40 mg de prednisona al día de forma ininterrumpida desde más de 14 días antes de la primera dosis de ceftolozano/tazobactam).
    10. El participante o un familiar directo (por ejemplo, padre/madre/tutor legal o hermano) forma parte del personal del centro de investigación o del personal del promotor implicado directamente en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    1.Percentage of participants with any adverse events (AEs)
    2.Percentage of participants with any serious AEs (SAEs)
    3.Percentage of participants with any drug-related AEs
    4.Percentage of participants with any drug-related SAEs
    5.Percentage of participants with AEs leading to discontinuation of study intervention
    1. Porcentaje de participantes con algún acontecimiento adverso (AA)
    2. Porcentaje de participantes con algún AA grave (AAG)
    3. Porcentaje de participantes con algún AA relacionado con el fármaco
    4. Porcentaje de participantes con algún AAG relacionado con el fármaco
    5. Porcentaje de participantes con AA que motiven la suspensión de la intervención del estudio
    E.5.1.1Timepoint(s) of evaluation of this end point
    1.Up to Day 31
    2.Up to Day 31
    3.Up to Day 31
    4.Up to Day 31
    5.Up to Day 14
    1. Hasta el día 31
    2. Hasta el día 31
    3. Hasta el día 31
    4. Hasta el día 31
    5. Hasta el día 14
    E.5.2Secondary end point(s)
    1.Plasma concentrations of ceftolozane
    2.Plasma concentrations of tazobactam
    3.Area under the concentration-time curve of an 8-hour dosing interval (AUC0-8) of plasma ceftolozane
    4.Area under the concentration-time curve of an 8-hour dosing interval (AUC0-8) of plasma tazobactam
    5.Maximum observed concentration during a dosage interval (Cmax) of plasma ceftolozane
    6.Maximum observed concentration during a dosage interval (Cmax) of plasma tazobactam
    7.Elimination half-life (t1/2) of plasma ceftolozane
    8.Elimination half-life (t1/2) of plasma tazobactam
    9.Volume of distribution (Vd) of plasma ceftolozane
    10.Volume of distribution (Vd) of plasma tazobactam
    11.Clearance (CL) of plasma ceftolozane
    12.Clearance (CL) of plasma tazobactam
    1. Concentraciones plasmáticas de ceftolozano
    2. Concentraciones plasmáticas de tazobactam
    3. Área bajo la curva de concentración en función del tiempo de un intervalo de administración de 8 horas (AUC0-8) de ceftolozano en plasma
    4. Área bajo la curva de concentración en función del tiempo de un intervalo de administración de 8 horas (AUC0-8) de tazobactam en plasma
    5. Concentración máxima observada durante un intervalo de administración (Cmáx) de ceftolozano en plasma
    6. Concentración máxima observada durante un intervalo de administración (Cmáx) de tazobactam en plasma
    7. Semivida de eliminación (t1/2) de ceftolozano en plasma
    8. Semivida de eliminación (t1/2) de tazobactam en plasma
    9. Volumen de distribución (Vd) de ceftolozano en plasma
    10. Volumen de distribución (Vd) de tazobactam en plasma
    11. Aclaramiento (CL) de ceftolozano en plasma
    12. Aclaramiento (CL) de tazobactam en plasma
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 3: 1, between 4-5, and between 7-8 hours after start of infusion
    Día 3: 1, entre 4 y 5 horas y entre 7 y 8 horas después del inicio de la infusión
    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 No
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Evaluate the safety, tolerability and the PK in pediatric participants
    Evaluar la seguridad, la tolerabilidad y la FC en participantes Pediatricos.
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    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 No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    Estonia
    Greece
    Russian Federation
    Spain
    Ukraine
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 40
    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: 5
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 5
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 12
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 12
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 14
    F.4.2.2In the whole clinical trial 40
    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
    Ninguno
    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 Decision2019-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-08
    P. End of Trial
    P.End of Trial StatusRestarted
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA