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   43843   clinical trials with a EudraCT protocol, of which   7282   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:2014-001826-13
    Sponsor's Protocol Code Number:200721
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-12-16
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-001826-13
    A.3Full title of the trial
    Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban Therapy for Women in Spontaneous Preterm Labor
    Estudio de fase III aleatorizado, doble ciego y multicéntrico para comparar la eficacia y la seguridad del tratamiento con retosibán frente a atosibán en mujeres en situación de parto pretérmino espontáneo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to compare Retosiban with Atosiban and show that retosiban is more effective in stopping spontaneous preterm labor and prolonges labor
    El fin del estudio es comparar retosibán con atosibán y demostrar que el atosibán es más efectivo en detener el parto pretérmino espontáneo y prolongar el parto.
    A.3.2Name or abbreviated title of the trial where available
    Study comparing the Efficacy and Safety of Retosiban Versus Atosiban in Spontaneous Preterm labor
    Estudio para comparar eficacia y seguridad de retosibán frente atosibán en parto pretérmino espontán
    A.4.1Sponsor's protocol code number200721
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/201/2013
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research & Development Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGlaxoSmithKline Research & Development Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Limited
    B.5.2Functional name of contact pointRobert Stocken
    B.5.3 Address:
    B.5.3.1Street AddressStockley Park West, 1-3 Ironbridge Road
    B.5.3.2Town/ cityUxbridge, Middlesex
    B.5.3.3Post codeUB11 1BT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number900834223
    B.5.5Fax number/
    B.5.6E-mailRegistroEspanolDeEstudiosClinicos@druginfo.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 nameRetosiban
    D.3.2Product code GSK221149
    D.3.4Pharmaceutical form 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 INNRetosiban
    D.3.9.1CAS number 820957-38-8
    D.3.9.2Current sponsor codeGSK221149A
    D.3.9.3Other descriptive nameGSK221149A
    D.3.9.4EV Substance CodeSUB29510
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 Tractocile
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Pharmaceuticals A/S
    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 Solution for injection
    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 INNATOSIBAN
    D.3.9.1CAS number 90779-69-4
    D.3.9.3Other descriptive nameTractocile
    D.3.9.4EV Substance CodeSUB05601MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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: 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 Tractocile
    D.2.1.1.2Name of the Marketing Authorisation holderFerring Pharmaceuticals A/S
    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 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 INNATOSIBAN
    D.3.9.1CAS number 90779-69-4
    D.3.9.3Other descriptive nameTractocile
    D.3.9.4EV Substance CodeSUB05601MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number7.5
    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
    preterm labor
    Parto pretérmino
    E.1.1.1Medical condition in easily understood language
    Restosiban stops preterm labor and prolongs pregnancy
    Retosibán detiene el parto pretérmino y prolonga el embarazo
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level PT
    E.1.2Classification code 10036595
    E.1.2Term Premature delivery
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the superiority of retosiban to prolong pregnancy compared with atosiban
    Demostrar la superioridad de retosibán sobre atosibán para prolongar la gestación.
    E.2.2Secondary objectives of the trial
    To describe the outcomes of newborns during the neonatal period (through 28 days post estimated date of delivery [EDD]) for retosiban compared with atosiban
    To describe the maternal, fetal, and neonatal safety profile during and after IV retosiban treatment compared with atosiban treatment
    To determine the effect of retosiban treatment compared with atosiban on health care resource use and patient-reported outcomes associated with the maternal and neonatal hospitalization
    To obtain further data on the pharmacokinetics of retosiban in pregnant women, including the effect of covariates such as age, weight, race/ethnicity, and GA on retosiban clearance and volume of distribution
    *Describir los resultados de los neonatos durante el período neonatal
    (hasta 28 días
    después de la fecha estimada de parto [FEP]) después del tratamiento
    de retosibán en
    comparación con atosibán.
    *Describir el perfil de seguridad materno, fetal, y neonatal durante y
    después de la administración intravenosa (i.v.) de retosibán en
    comparación con atosibán.
    *Determinar el efecto del tratamiento de retosibán en comparación con atosibán sobre
    la utilización de recursos sanitarios y los resultados comunicados por las
    pacientes en relación con la hospitalización materna y neonatal.
    *Recabar nuevos datos sobre la farmacocinética de retosibán en las
    mujeres embarazadas, incluido el efecto de covariables como la edad, el peso, la raza o grupo étnico y la edad gestacional (EG) sobre la eliminación y el volumen de distribución de retosibán.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Signed and dated written informed consent is required prior to a subject´s participation in the study and the performance of any protocol specific procedures. Adolescents aged 12 to 17 years must provide written agreement to participate in the study in accordance with applicable regulatory and country or state requirements. Subjects will also be asked to sign a release for medical records at the time of consenting to allow access to both the maternal and neonatal records including information about delivery and infant care as well as information collected prior to the consent having been signed
    Note: Prescreening alone does not necessarily require consent as this activity may be accomplished in the absence of study specific procedures or assessments. In many cases, standard care and standard medical triage will provide sufficient information or evidence as to whether or not the subject is eligible for the study
    2.Females aged 12 to 45 years, with an uncomplicated, singleton pregnancy and intact membranes in preterm labor (Note: This protocol includes pregnant adolescents, aged 12 to 17 years, as appropriate, based on national or local regulations.)
    3.Gestational age between 240/7 and 336/7 weeks as determined by (1) known fertilization date, either in vitro fertilization or intrauterine insemination, (2) last menstrual period confirmed by the earliest ultrasound prior to 240/7 weeks gestation, or (3) the earliest ultrasound alone prior to 240/7 weeks gestation, whichever is the most accurate method available for each subject. In situations where prenatal ultrasound records are not available at the time the subject presents, the investigator will make every effort to obtain these records (either via computer records, directly from the subject´s primary care obstetrician, or via telephone). However, in cases in which these records are not readily available (e.g., off hours, holiday), it is within the investigator´s discretion to use GA based on a verbal history from the subject with the intent of getting confirmation from the medical records as soon as possible
    4.Subjects must be diagnosed with preterm labor according to both of the following criteria:
    a.Regular uterine contractions at a rate of >=4 contractions of at least 30 seconds duration during a 30-minute interval confirmed by tocodynamometry
    AND at least 1 of the following:
    b.Cervical dilation >=2 cm and <=4 cm by digital cervical examination OR
    c.If <2 cm dilation by digital cervical examination, a cervical change consisting of an increase of at least 25% effacement or 1 cm dilation
    5.Treatment naïve subjects and subjects not adequately responding to tocolytics other than atosiban (e.g., transfers from other care units) during their current episode of preterm labor may be eligible for the study. Historical failure of a tocolytic treatment in a previous episode of preterm labor is not a required inclusion criterion. Tocolytic failure is defined by progressive cervical changes or continuing uterine contractions
    1. Se requiere la firma y fecha del consentimiento informado por escrito antes de la participación del sujeto en este estudio y de iniciar cualquier procedimiento estipulado por protocolo. Las adolescentes de 12 a 17 años aceptarán por escrito la participación en el estudio de conformidad con las leyes nacionales y locales de aplicación. A la firma del consentimiento, se pedirá también al sujeto que firme una autorización de acceso a los archivos médicos maternos y neonatales, incluida la información sobre el parto y los cuidados del neonato y toda información obtenida antes de la firma del consentimiento.
    Nota: la preselección en sí no requiere el consentimiento, ya que se puede efectuar sin que medien evaluaciones o procedimientos específicos del estudio. En muchos casos, las prácticas de triaje y de asistencia habituales proporcionarán información o datos suficientes para determinar si el sujeto es elegible o no para el estudio.
    2. Mujeres de 12 a 45 años de edad, con embarazo de feto único no complicado y membranas intactas en situación de parto pretérmino (Nota: en este protocolo se incluirán adolescentes de 12 a 17 años, cuando proceda, de conformidad con la normativa nacional o local.)
    3. Edad gestacional entre 240/7 y 336/7 semanas, determinada por: (1) la fecha de fecundación conocida, ya sea fecundación in vitro o inseminación intrauterina; (2) el último período menstrual confirmado por la ecografía más antigua anterior a la 240/7 semana de gestación; o (3) la ecografía más antigua anterior a la 240/7 semana de gestación, lo que resulte más exacto en cada caso. En los casos en que no se disponga de registros de ecografía prenatal al presentarse la paciente, el investigador procurará por todos los medios obtener esta información, ya sea a través de los registros informatizados, directamente del ginecólogo de atención primaria, o por teléfono. Sin embargo, cuando no sea fácil acceder a los registros (p. ej., por motivos de horario o de fechas vacacionales), quedará a criterio del investigador usar la EG basándose en la anamnesis obtenida verbalmente de la paciente, en la idea de contrastarla con los registros médicos lo antes posible.
    4. Las pacientes tendrán que tener un diagnóstico de parto pretérmino basado en los dos criterios siguientes:
    a. Contracciones uterinas regulares a un ritmo >=4 contracciones de al menos 30 segundos de duración en un intervalo de 30 minutos, confirmado mediante tocodinamometría
    Y al menos 1 de las circunstancias siguientes:
    b. Dilatación cervical >=2 cm y <=4 cm determinada mediante tacto digital cervical, O
    c. Si el tacto digital cervical revela dilatación <2 cm, un cambio cervical consistente en aumento del borramiento del 25% como mínimo o dilatación de 1 cm.
    5. Podrán participar en este estudio las pacientes no tratadas previamente y las que no respondan adecuadamente a tocolíticos distintos del atosibán (p. ej., casos de traslado desde otras unidades) durante el episodio actual de parto pretérmino. Los antecedentes de fracaso del tratamiento tocolítico en un episodio previo de parto pretérmino no constituyen un criterio de inclusión obligatorio. El fracaso tocolítico se define como la presencia de cambios cervicales progresivos o contracciones uterinas continuas.
    E.4Principal exclusion criteria
    1.Fever with a temperature greater than 100.4°F (38°C) for more than 1 hour or >=101°F (38.3°C) in the 24 hours prior to the start of study treatment
    2.Women with maternal-fetal conditions that potentially necessitate the need for delivery, such as pre-eclampsia or fetal compromise
    3.A fetus with any diagnosis, condition, treatment, or other factor that in the opinion of the investigator has the potential to affect or confound assessments of efficacy or safety (e.g., nonreassuring fetal status, intrauterine growth restriction, major congenital anomaly)
    4.Preterm premature rupture of membranes
    5.Women with any confirmed or suspected contraindication to prolongation of pregnancy, such as placental abruption, chorioamnionitis, or placenta previa
    6.Evidence of polyhydramnios (amniotic fluid index [AFI] >25 cm) or oligohydramnios (AFI <5 cm)
    7.Women with co-morbid medical or obstetric conditions that in the opinion of the investigator have the potential to complicate the pregnancy course and outcomes, such as uncontrolled hypertension, uncontrolled diabetes (if known, history of glycosylated hemoglobin >8% at any time during pregnancy), or compromise the safety of the subject, such as underlying cardiovascular disorder (specifically ischemic cardiac disease, congenital heart disease, pulmonary hypertension, valvular heart disease, arrhythmias, and cardiomyopathy)
    8.Women with a history of substance abuse or urine drug screen findings suggestive of substance abuse that may either be implicated as the cause of preterm labor (e.g., abuse of cocaine or methamphetamines) or have the potential to complicate the pregnancy outcome (e.g., alcohol abuse or opioid addiction)
    9.Women with any diagnosis, condition, treatment, or other factor that in the opinion of the investigator has the potential to affect or confound assessments of efficacy or safety
    10.Women with documented active hepatitis B or hepatitis C viral infection, unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert?s syndrome or asymptomatic gallstones)
    11.History of sensitivity to the IPs or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK/PPD medical monitor,
    1.Fiebre con una temperatura superior a 38°C durante más de 1 hora o >=38,3°C en las 24 horas que preceden al inicio del tratamiento del estudio
    2.Circunstancias maternofetales que posiblemente hagan necesario el parto, como la preeclampsia o el compromiso del feto
    3.Un feto con un diagnóstico, trastorno, tratamiento o cualquier otro factor que, a juicio del investigador, pueda influir o introducir confusión en las evaluaciones de la eficacia y la seguridad (p. ej., estado preocupante del feto, restricción del desarrollo intrauterino o anomalías congénitas importantes)
    4.Rotura prematura de membranas pretérmino
    5.Mujeres con una contraindicación sospechada o confirmada para prolongar el embarazo, como desprendimiento de placenta, corioamnionitis o placenta previa
    6.Signos de polihidramnios (índice de líquido amniótico [ILA] > 25 cm) o de oligohidramnios (ILA < 5 cm)
    7.Mujeres con factores médicos u obstétricos de comorbilidad que, a juicio del investigador, puedan complicar el curso y el resultado del embarazo, como hipertensión no controlada, diabetes no controlada (si se conocen, antecedentes de hemoglobina glicosilada > 8% en algún momento del embarazo) o comprometer la seguridad de la paciente, como un trastorno cardiovascular subyacente (en particular, cardiopatía isquémica o congénita, hipertensión pulmonar, cardiopatías valvulares, arritmias y miocardiopatía)
    8.Mujeres con antecedentes de toxicomanía o en las que el análisis toxicológico en orina indique abuso de sustancias que puedan haber causado el parto pretérmino (p. ej., consumo de cocaína o metanfetaminas) o complicar el pronóstico del embarazo (p. ej., alcoholismo o adicción a opiáceos)
    9.Mujeres con un diagnóstico, trastorno, tratamiento o cualquier otro factor que, a juicio del investigador, pueda influir o introducir confusión en las evaluaciones de la eficacia y la seguridad
    10.Mujeres con infección activa documentada por virus de la hepatitis B o C, enfermedad hepática no estabilizada (definida por la presencia de ascitis, encefalopatía, coagulopatía, hipoalbuminemia, varices esofágicas o gástricas o ictericia persistente), cirrosis o trastornos biliares conocidos (exceptuando el síndrome de Gilbert y la presencia de cálculos biliares asintomáticos)
    11.Antecedentes de sensibilidad al producto en investigación (PEI) o a sus componentes o una historia clínica de alergia a fármacos o de otro tipo que, a juicio del investigador o del monitor médico de GSK/PPD, contraindique la participación.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is time to delivery from the start of IP administration until delivery,
    El criterio de valoración principal de la eficacia es el tiempo transcurrido desde el inicio de la administración del PEI hasta el parto.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 hours after IP infusion, then every week till delivery.
    48 horas después de la infusión del PEI, luego cada semana hasta el parto
    E.5.2Secondary end point(s)
    The following are the key secondary efficacy endpoints:
    Proportion of births prior to 370/7 weeks gestation
    Proportion of births at term (370/7 to 416/7 weeks gestation)
    Length of neonatal hospital stay
    Proportion of neonates with any diagnosis from the neonatal morbidity and mortality composite determined up to 28 days after EDD (of 400/7 weeks) (details for each composite are provided in Section 6.2.2)
    Fetal or neonatal death
    Respiratory distress syndrome (RDS)
    Bronchopulmonary dysplasia
    Necrotizing enterocolitis or isolated perforation
    Sepsis
    Meningitis
    Retinopathy of prematurity
    Intraventricular hemorrhage (IVH)
    White matter injury,
    Cerebellar hemorrhage

    The following are other secondary efficacy endpoints:
    Proportion of neonates with any of the composite neonatal morbidity and mortality excluding RDS
    Proportion of neonates with each individual component of the composite neonatal morbidity and mortality endpoints
    Neonatal admission to a specialized care unit and length of stay
    Newborn hospital readmission and length of stay
    Ambulatory surgery
    Proportion of births prior to 280/7 weeks gestation
    Proportion of births prior to 320/7 weeks gestation
    Proportion of births <=7 days
    Proportion of births <=48 hours
    Proportion of births <=24 hours

    The following are the safety endpoints (maternal, fetal, and neonatal, as appropriate):
    Incidence of reported AEs and serious AEs
    Significant changes in vital signs and clinical laboratory tests
    Incidence of treatment-limiting toxicities including both clinical and laboratory etiology causing subject to discontinue study treatment
    Edinburgh Postnatal Depression Scale
    Follow-up amniotic fluid index determined by abdominal ultrasound
    Fetal acidosis
    Neonatal Apgar scores (at 1 and 5 minutes after birth), growth parameters (weight, length, and head circumference) at birth and at discharge, and documentation of any complications
    AEs of special interest
    Maternal
    Death
    Chorioamnionitis and its complications
    Placental abruption
    Postpartum hemorrhage and/or retained placenta
    Pulmonary edema
    Fetal
    Intrauterine fetal demise
    Category II or III fetal heart rate tracing (defined according to American College of Obstetricians and Gynecologists Practice Bulletin 106 [ACOG, 2009])
    Fetal inflammatory response syndrome
    Neonatal
    Neonatal death
    Asphyxia
    Infections (early onset neonatal sepsis, septic shock, pneumonia, meningitis)
    RDS
    Hypotension
    Intraventricular hemorrhage/periventricular leukomalacia
    Bronchopulmonary dysplasia
    Neonatal acidosis
    Hyperbilirubinemia
    Neonatal enterocolitis
    Hypoxic ischemic encephalopathy
    Los criterios de valoración secundarios más importantes son los siguientes:
    *Proporción de nacimientos antes de la semana 370/7 de gestación.
    *Proporción de nacimientos a término (semanas 370/7 a 416/7 de gestación).
    *Duración de la estancia hospitalaria neonatal.
    *Proporción de recién nacidos con un diagnóstico compuesto de morbilida y mortalidad emitido hasta 28 días después de la fecha estimada de parto (FEP) (semana 400/7)
    - Muerte fetal o neonatal
    - Síndrome de dificultad respiratoria aguda (SDRA)
    - Displasia broncopulmonar
    - Enterocolitis necrosante o perforación aislada
    - Septicemia
    - Meningitis
    - Retinopatía del prematuro
    - Hemorragia intraventricular (HIV)
    - Lesión de la sustancia blanca
    - Hemorragia cerebelosa

    Otros criterios de valoración secundarios son los siguientes:
    *Proporción de recién nacidos con algún factor de morbimortalidad neonatal compuesta, excluido el SDRA
    *Proporción de recién nacidos con cada componente individual de la composición de morbilidad y mortalidad neonatal y criterios de valoración
    *Ingreso neonatal en una unidad de cuidados especiales y duración de la estancia.
    *Reingreso del recién nacido y duración de la estancia en el hospital
    *Cirugía ambulatoria
    *Proporción de nacimientos antes de la semana 280/7 de gestación
    *Proporción de nacimientos antes de la semana 320/7 de gestación
    *Proporción de nacimientos en <= 7 días
    *Proporción de nacimientos en <= 48 horas
    *Proporción de nacimientos en <= 24 horas

    Los criterios de valoración de la seguridad (materna, fetal y neonatal, según esté indicado) son los siguientes:
    *Incidencia de AA y de AA graves notificados.
    *Cambios importantes en las constantes vitales y los resultados de los análisis clínicos.
    *Incidencia de signos de toxicidad limitante del tratamiento, de carácter clínico o analítico, que obliguen a la paciente a suspender el tratamiento del estudio.
    *Escala de depresión puerperal de Edimburgo (Edinburgh Postnatal Depression Scale)
    *Seguimiento del Índice de líquido amniótico determinado mediante ecografía abdominal
    *Acidosis fetal
    *Puntuación neonatal de Apgar (1 y 5 minutos después del nacimiento), parámetros de crecimiento (talla, peso y perímetro cefálico) en el momento de nacer y al recibir el alta domiciliaria y documentación de cualquier complicación
    *AA de interés especial
    - Materna
    o Muerte
    o Corioamnionitis y sus complicaciones
    o Desprendimiento de placenta
    o Hemorragia puerperal o retención de placenta
    o Edema pulmonar
    - Fetal
    o Muerte fetal intrauterina
    o Registro de la frecuencia cardíaca fetal de categoría II o III (según se define en el Boletín 106 del Colegio Americano de Obstetras y Ginecólogos [ACOG, 2009])
    o Síndrome de respuesta inflamatoria fetal
    - Neonatal
    o Muerte neonatal
    o Asfixia
    o Infecciones (septicemia neonatal de aparición precoz, shock séptico, neumonía o meningitis)
    o SDRA
    o Hipotensión
    o Hemorragia intraventricular o leucomalacia periventricular
    o Displasia broncopulmonar
    o Acidosis neonatal
    o Hiperbilirrubinemia
    o Enterocolitis neonatal
    o Encefalopatía hipóxico-isquémica
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 hours after IP infusion, then every week till delivery.
    48 horas después de la infusión del PEI, luego cada semana hasta el parto
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    doble simulación
    double dummy
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA38
    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
    Belgium
    France
    Germany
    Israel
    Italy
    Korea, Republic of
    Mexico
    Spain
    Sweden
    United Kingdom
    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
    The end of trial will be when all the subjects have been contacted via telephone for the Maternal Post-Delivery Assessment Phase within 6 weeks (±2 weeks) following delivery. The neonatologist subinvestigator will then conduct a review of the newborn birth hospitalization records, following discharge from an acute care setting through 28 days EDD, where EDD is defined as 40 0/7 weeks' gestation for all subjects.
    El fin de ensayo será cuando todos los pacientes hayan sido contactados por teléfono para la fase de evaluación postparto materna en las 6 semanas (±2 semanas) siguientes al parto. El subinvestigador neonatólogo hará una revisión de los registros de hospitalización del neonato, desde el alta de la unidad de cuidados intensivos o especializados hasta 28 días después de la fecha estimada de parto (FEP), definiendo la FEP como la semana 40 0/7 de gestación en todos los casos.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 6
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 324
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 No
    F.3.3.3Pregnant women Yes
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 330
    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 investigator is responsible for ensuring that consideration has been given to the poststudy care of the subject´s medical condition whether or not GSK is providing specific poststudy treatment.
    Poststudy IP is not provided as part of this protocol.
    El investigador es responsable de garantizar la atención médica de las pacientes después del estudio, con independencia de que GSK proporcione o no tratamiento específico después del ensayo.
    No se suministrará el medicamento en investigación después del estudio como parte de este protocolo.
    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 Decision2015-01-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-25
    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