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    Summary
    EudraCT Number:2014-003217-28
    Sponsor's Protocol Code Number:14-OBE001-016
    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 number2014-003217-28
    A.3Full title of the trial
    A phase 2, double-blind, parallel group, randomised, placebo controlled, proof of concept study to assess the safety and efficacy of OBE001 after oral administration in pregnant women with threatened preterm labour.
    Estudio de demostración preliminar de la eficacia de fase II, doble ciego, de grupos paralelos, aleatorizado y controlado con placebo para evaluar la seguridad y la eficacia de OBE001 después de la administración oral a mujeres embarazadas con riesgo de parto prematuro. (TERM)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 2 study of OBE001 versus placebo in the delay of preterm birth.
    Estudio de fase 2 de OBE001 versus placebo para retrasar el parto prematuro.
    A.3.2Name or abbreviated title of the trial where available
    TERM
    TERM
    A.4.1Sponsor's protocol code number14-OBE001-016
    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 SponsorObsEva SA
    B.1.3.4CountrySwitzerland
    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 supportObsEva SA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationObsEva SA
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressChemin des Aulx, 12
    B.5.3.2Town/ cityPlan-les-Ouates, Geneva
    B.5.3.3Post code1228
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number34917088600
    B.5.5Fax number41227432921
    B.5.6E-mailclinicaltrials@obseva.ch
    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 nameOBE001
    D.3.2Product code OBE001
    D.3.4Pharmaceutical form Dispersible tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOBE001
    D.3.9.1CAS number 1477482-19-1
    D.3.9.2Current sponsor codeOBE001
    D.3.9.3Other descriptive nameOBE001
    D.3.9.4EV Substance CodeSUB130545
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboDispersible tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of preterm labour
    Tratamiento para el parto prematuro
    E.1.1.1Medical condition in easily understood language
    Treatment of preterm labour
    Tratamiento para el parto prematuro
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level SOC
    E.1.2Classification code 10036585
    E.1.2Term Pregnancy, puerperium and perinatal conditions
    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 compare the efficacy of OBE001 with placebo to delay preterm birth by 7 days.
    Comparar la eficacia de OBE001 con placebo para retrasar en 7 días un nacimiento prematuro.
    E.2.2Secondary objectives of the trial
    To compare the efficacy of OBE001 with placebo to delay preterm birth by 48 hours.
    To compare the efficacy of OBE001 with placebo to delay birth until gestational week 37.
    To assess maternal and foetal exposure to OBE001.
    To evaluate the effect of OBE001 on frequency of uterine contractions.

    safety objectives:
    To evaluate the maternal and foetal safety of OBE001.
    To evaluate the newborn neonatal morbidity up to 28 days post expected term date.
    Comparar la eficacia de OBE001 con placebo para retrasar en 48 horas un nacimiento prematuro.
    Comparar la eficacia de OBE001 con placebo para retrasar el nacimiento hasta la finalización de la semana 37 de gestación.
    Evaluar la exposición materna y fetal al OBE001.
    Evaluar el efecto de OBE001 en la frecuencia de las contracciones uterinas.

    Seguridad
    Evaluar la seguridad materna y fetal del OBE001.
    Evaluar la morbilidad neonatal del recién nacido hasta 28 días después de la fecha prevista de parto.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pregnant females aged mayor or equal 18 years.
    2. Subjects with a singleton pregnancy.
    3. GA between 34 0/7 and 35 6/7 weeks as confirmed by best obstetric estimate, preferably first trimester US scan.
    4. Subjects with symptoms of preterm labour
    5. Able to communicate well with the investigator and research staff and to comply with the requirements of the entire study.
    6. Provision of written informed consent to participate as shown by a signature on the subject consent form.
    1. Mujeres embarazadas de 18 o más años de edad.
    2. Sujetos con embarazos de un solo feto.
    3. Edad gestacional (EG) entre 34 0/7 y 35 6/7 semanas confirmadas por la mejor estimación obstétrica, preferiblemente con ecografía durante el primer trimestre.
    4. Sujetos con síntomas de parto prematuro
    5. Poder comunicarse bien con el investigador y el personal de la investigación, y cumplir los requisitos durante todo el estudio.
    6. Proporcionar el consentimiento informado por escrito para participar mediante la firma del formulario de consentimiento del sujeto.
    E.4Principal exclusion criteria
    1. Foetal death in utero in current pregnancy or in previous pregnancy after gestational week 24 or expected high risk of foetal death in the coming days.
    2. Any contraindications for the mother or the foetus to stop labour or prolong pregnancy or any maternal or foetal conditions likely to indicate iatrogenic delivery in the next 7 days, including:
    a. Premature rupture of membranes
    b. Evidence or suspicion of abruptio placenta
    c. Signs and/or symptoms of chorio-amnionitis
    d. Eclampsia or severe pre-eclampsia
    e. Foetal distress as assessed by the investigator
    3. The Subject has any condition which in the opinion of the PI constitutes a risk or a contraindication for the participation of the subject in the trial or that could interfere with the trial objectives, conduct or evaluation, including:
    a. Any clinically significant abnormality in the results of the screening safety laboratory tests, including AST, ALT, GGT, alkaline phosphatase or total bilirubin > ×2 ULN for women in the 3rd trimester of pregnancy (to be confirmed within 24 hours of randomisation).
    b. Any clinically significant and trial relevant abnormality in the results of the screening physical examination including a gynaecological examination.
    c. Any clinically significant abnormality on the 12-lead ECG recording at screening (to be assessed up to 24 hours after randomisation).
    d. The Subject has known positive results from virology tests for HBsAg (not due to vaccination), HBcAb, HCV or HIV 1 or 2.
    e. The Subject is prone to frequent, severe hypersensitivity to drugs.
    f. Evidence of recent drug or alcohol abuse.
    g. The Subject is planning to deliver in another location than the investigational site.
    4. The Subject had a BMI mayor or equal to 35 kg/m2 prior to current pregnancy.
    5. Use of cervical cerclage or a pessary in the current pregnancy.
    6. Treatment with nifedipine, nicardipine or other calcium channel blockers, oral or injectable NSAIDs, betamimetics, nitric oxide donors or intravenously administered magnesium sulphate within 2 weeks of Study Day 1.
    7. Administration of atosiban or other OT antagonists or any experimental drug during the current pregnancy.
    1. Muerte fetal en el útero durante el embarazo actual o en un embarazo anterior después de la semana 24 de gestación, o alto riesgo previsto de muerte fetal en los días siguientes.
    2. Cualquier contraindicación para la madre o el feto de detener el parto o prolongar el embarazo, o cualquier afección materna o fetal con probabilidad de indicar un parto iatrógeno en los 7 días siguientes, incluidos:
    a. Ruptura prematura de membranas
    b. Evidencia o sospecha de desprendimiento de placenta
    c. Signos y/o síntomas de corioamnionitis
    d. Eclampsia o preeclampsia grave
    e. Sufrimiento fetal según evaluación del investigador
    3. El sujeto tiene cualquier afección que constituya según el criterio del IP un riesgo o contraindicación para la participación del sujeto en el ensayo, o que podría interferir con los objetivos, la realización o la evaluación del ensayo, incluidos:
    a. Cualquier anomalía clínicamente significativa en los resultados de los análisis de seguridad durante la selección, incluidas concentraciones de aspartato transaminasa (AST), alanina transaminasa (ALT), gamma glutamil transaminasa (GGT), fosfatasa alcalina o bilirrubina total mayor de dos veces el límite superior normal (LSN) en mujeres en el tercer trimestre del embarazo (a confirmar en las 24 horas siguientes a la aleatorización):
    b. Cualquier anomalía clínicamente significativa y relevante para el ensayo de los resultados de la exploración física durante la selección, incluida la exploración ginecológica.
    c. Cualquier anomalía clínicamente significativa del registro del ECG de 12 derivaciones durante la selección (a evaluarse hasta 24 horas después de la aleatorización).
    d. El sujeto ha dado resultados positivos conocidos en los análisis virológicos de antígeno de superficie de la hepatitis B (HBsAg) (no debido a vacunación), anticuerpo contra el antígeno central del virus de la hepatitis B (HBcAb), hepatitis C (VHC) o virus de la inmunodeficiencia humana (VIH) 1 o 2.
    e. El sujeto es proclive a hipersensibilidad frecuente y grave a medicamentos.
    f. Evidencia de abuso reciente de alcohol o drogas.
    g. El sujeto tiene previsto dar a luz en una ubicación distinta al centro de investigación.
    4. El sujeto tenía un IMC mayor o igual a 35 kg/m2 antes del embarazo actual.
    5. Utilización de cerclaje o pesario cervicouterino en el embarazo actual.
    6. Tratamiento con nifedipino, nicardipino u otro bloqueante de los canales de calcio, AINE orales o inyectables, betamiméticos, donantes de óxido nítrico o sulfato de magnesio administrado de forma intravenosa en las dos semanas anteriores al día 1 del estudio.
    7. Administración de atosiban u otro antagonista de la oxitocina, o cualquier medicamento experimental durante el embarazo actual.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of women delivering within 7 days post first dose (i.e. within 168 hours of first dose).
    Incidencia de mujeres que dan a luz en los 7 días siguientes a la primera dosis (es decir, en las 168 horas siguientes a la primera dosis)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the time of the interim analysis (when 60 randomised subjects will have either completed the study day 14 and/or have terminated the study and/or have been withdrawn early) and at the end of the study.
    Se realizará un análisis intermedio (cuando 60 sujetos aleatorizados hayan finalizado el día 14 del estudio y/o hayan terminado el estudio y/o se hayan retirado prematuramente) y al final del estudio.
    E.5.2Secondary end point(s)
    Incidence of women delivering within 48 hours post first dose.
    Incidence of women delivering before gestational age 37 0/7 weeks.
    The progression of uterine contractions from pre-dose to 6 hours and 24 hours post first dose as measured by tocodynamometry.
    Maternal plasma concentrations of OBE001 on Day 1 (2 hours post first dose), on Day 2 (pre-dose and 2 hours post-dose), on Day 3 (pre-dose), on Day 7 (post-dose) and at the time of delivery. Umbilical cord plasma concentration of OBE001 at the time of delivery (time matched with maternal sample).

    Safety endpoints:
    Maternal incidence of AEs, TEAEs, clinically significant changes in laboratory safety tests, 12-lead ECGs morphology or vital signs from Day 1 until 28 days after birth or term whichever is later.
    Incidence of foetal distress as determined by clinically significant changes in growth retardation and/or foetal heart rate monitoring and/or AFI from Day 1 to Day 14 or birth, whichever is earlier.
    Incidence of infants experiencing adverse events assessed by vital signs, temperature, APGAR score, weight and head circumference at birth as well as measures of neonatal morbidity from birth until 28 days after birth or term whichever is later.
    Incidencia de mujeres que dan a luz en las 48 horas siguientes a la primera dosis.
    Incidencia de mujeres que dan a luz antes de la edad gestacional de 37 0/7 semanas.
    La progresión de las contracciones uterinas desde antes de la dosis hasta 6 horas y 24 horas después de la primera dosis mediante tocodinamometría.
    Concentraciones en plasma materno de OBE001 el día 1 (2 horas después de la primera dosis), el día 2 (antes de la dosis y dos horas después de la dosis), el día 3 (antes de la dosis), el día 7 (después de la dosis) y en el momento del parto. Concentración de OBE001 en plasma de cordón umbilical en el momento del parto (al mismo tiempo que la muestra materna).

    Seguridad
    Incidencia materna de acontecimientos adversos (AA), acontecimientos adversos surgidos durante el tratamiento (AADT), cambios clínicamente significativos en los test de laboratorio de seguridad, morfología de los ECG de 12 derivaciones o constantes vitales desde el día 1 hasta 28 días después del parto o a término, lo que suceda más tarde.
    Incidencia de sufrimiento fetal determinado por cambios clínicamente significativos en retraso del crecimiento y monitorización de la frecuencia cardíaca fetal (CTG) y/o índices de líquido amniótico (ILA) del día 1 al día 14 o el día del parto, lo que suceda antes.
    Incidencia de acontecimientos adversos para los bebés evaluados por constantes vitales, temperatura, puntuación APGAR, peso y circunferencia craneal al nacer, así como medidas de morbilidad neonatal desde el nacimiento hasta 28 días después del parto o a término, lo que suceda más tarde.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the time of the interim analysis (when 60 randomised subjects will have either completed the study day 14 and/or have terminated the study and/or have been withdrawn early) and at the end of the study.

    In addition, the DMC will review safety data on at least 2 occasions during the recruitment period and as soon as the first 30 subjects have been randomised.
    Se hará un análisis intermedio cuando 60 sujetos aleatorizados hayan finalizado el día 14 del estudio y/o hayan terminado el estudio y/o se hayan retirado prematuramente y al final del estudio.

    Además, el CVD revisará los datos de seguridad en al menos 2 ocasiones durante el período de reclutamiento y tan pronto como se haya aleatorizado a los primeros 30 sujetos
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    For administrative and safety reporting purposes the end of the study will be defined as the date of the final clinical database lock.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    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 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 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: 100
    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 state35
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    There will be an observational, safety follow-up of the infants for 2 years (starting from the end of the maternal and neonatal follow up period) as a separate protocol.
    Se realizará un seguimiento observacional de seguridad de los bebés durante 2 años (desde el final del período de seguimiento materno y neonatal) como protocolo independiente.
    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 Decision2015-01-22
    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 StatusCompleted
    P.Date of the global end of the trial2016-10-28
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