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    Summary
    EudraCT Number:2014-000499-24
    Sponsor's Protocol Code Number:200722
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2015-06-29
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-000499-24
    A.3Full title of the trial
    Follow-Up Study to Assess Long-Term Safety and Outcomes in Infants Born to Mothers Participating in Retosiban Treatment Studies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study is to monitor the safety of the medications used in the preterm labor study by collecting information on the health and development of the child after child’s mother participated in a retosiban study for preterm labor during the child’s mother’s pregnancy.
    A.3.2Name or abbreviated title of the trial where available
    Follow-Up Study to Assess Long-Term Safety of Infants exposed to Retosiban
    A.4.1Sponsor's protocol code number200722
    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 number00442089903879
    B.5.5Fax number00442089903511
    B.5.6E-mailrobert.c.stocken@gsk.com
    D. IMP Identification
    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 labour and improve neonatal health
    E.1.1.1Medical condition in easily understood language
    preterm labor and the health and development of the child after the child’s mother participated in a retosiban study for preterm labor during mother’s pregnancy.
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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
    The study objective is to assess the safety and outcomes in infants who were exposed to retosiban or comparator in the Phase III treatment studiess.
    Specific objectives include the following:
    •To characterize the clinical safety in terms of infant morbidity and mortality in infants exposed to retosiban or comparator
    •To characterize the clinical safety in terms of neurodevelopment in infants exposed to retosiban or comparator
    •To characterize parental productivity loss related to a sick child and infant resource utilization in terms of hospital admissions, length of stay, emergency room/urgent care (ER/UC) visits, surgical procedures, and referral to specialty care or therapy visits for infants exposed to retosiban or comparator
    E.2.2Secondary objectives of the trial
    Not Applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Infants eligible for enrollment in the study must meet all of the following criteria:
    1.Mother is randomly assigned and dosed (retosiban or comparator) in 1 of the Phase III retosiban clinical studies.
    2.Infant is alive at 28 days post EDD.
    3.Written informed consent is obtained from the parent(s) or legal guardian(s) of the infant. The parent/legal guardian of participants aged 12 to 17 years must also provide written agreement for the infant to participate in the study where required by applicable regulatory and country or state requirements.
    E.4Principal exclusion criteria
    All infants who meet the inclusion criteria will be eligible to enroll in the study. There are no formal exclusion criteria for participation.
    E.5 End points
    E.5.1Primary end point(s)
    Morbidity and mortality endpoints:
    •Proportion of infants with newly diagnosed (after 28 days post EDD) chronic medical conditions by type of condition will be recorded and include the following:
    •Respiratory conditions
    •Neurological conditions
    •Sensory conditions
    •Gastrointestinal conditions
    •Cardiovascular conditions
    •Renal conditions
    •Growth parameters
    •Proportion of infants with newly diagnosed (after 28 days post EDD) congenital anomalies
    •Proportion of neonatal and infant deaths after 28 days post EDD and until the end of the study
    E.5.1.1Timepoint(s) of evaluation of this end point
    collection of neonatal morbidity data and will occur at 28 days after the estimated date of delivery (EDD) and the infant's parent/legal guardian will be asked to complete a Child Health Inventory at 2, 6, 9, 12, 15, 18, 21, and 24 months of the child’s chronological age
    E.5.2Secondary end point(s)
    Neurodevelopment endpoints:
    •Neurodevelopment endpoints assessed at ages 9, 18, and 24 months, corrected for prematurity:
    •Proportion of infants with an ASQ-3 score in the black zone in any domain
    •Proportion of infants with an ASQ-3 score in the black zone for gross motor skills
    •Proportion of infants with an ASQ-3 score in the black zone for fine motor skills
    •Proportion of infants with an ASQ-3 score in the black zone for communication
    •Proportion of infants with an ASQ-3 score in the black zone for problem solving
    •Proportion of infants with an ASQ-3 score in the black zone for personal-social skills
    •Proportion of infants referred for developmental evaluation (using BSID III)
    •Proportion of infants with a BSID-III score <2 SDs below the mean score for the cognitive impairment (<70)
    •Proportion of infants with BSID-III score <2 SDs below the mean score for the gross motor scale (<70)
    •Proportion of infants with BSID-III score <2 SDs below the mean score for the fine motor scale (<70)
    •Proportion of infants with a BSID-III score <2 SDs below the mean score for the language scale (<70)
    •Proportion of infants referred for an additional behavioral assessment using the CBCL/1.5-5 and M-CHAT-R/F
    •Proportion of infants with a CBCL/1.5–5 score at or above the 97th percentile for a subset of prespecified questions that relate to attention and hyperactivity problems
    •Proportion of infants indicated as needing further evaluation after completion of the M CHAT R/F
    •Proportion of infants referred for neurological evaluation to determine diagnosis of cerebral palsy
    •Proportion of infants with at least 1 of the following indicators of neurodevelopmental impairment at the end of the study:
    •Hearing impaired, uncorrected even with aids
    •Blindness in 1 or both eyes, or sees light only
    •Cerebral palsy (moderate and severe)
    •Cognitive impairment: BSID-III Cognitive Scale Score of <2 SDs below mean score (<70)
    •Motor impairment: BSID-III Motor Composite Scale Score of <2 SDs below mean score (<70)

    Resource utilization endpoints:
    •Number of hospital admissions, proportion of infants with any hospital admission, post-birth hospitalization discharge, by principal and secondary discharge diagnosis, type of hospital unit admitted to (e.g., NICU, Pediatric, PICU, Nursery level 3, ICU), and length of hospital stay per unit after 28 days post EDD.
    •Combined length of hospital stay in days for all hospital admissions (for infants discharged from the delivery hospitalization and for babies who were never discharged home post-delivery) after 28 days post EDD.
    •Number of ER/UC visits and proportion of infants with any ER/UC visit after 28 days post EDD.
    •Number of surgical procedures (by type and whether performed on an inpatient basis or at an outpatient/surgical center) after 28 days post EDD.
    •Number of specialty care or therapy visits and proportion of infants referred for specialty care or therapy by type of care/therapy after 28 days post EDD.
    •Parental productivity loss related to infant hospital admissions, ER/UC visits, or specialist care after 28 days post EDD.
    E.5.2.1Timepoint(s) of evaluation of this end point
    28 days after the estimated date of delivery (EDD) and the infant's parent/legal guardian will be asked to complete a Child Health Inventory at 2, 6, 9, 12, 15, 18, 21, and 24 months of the child’s chronological age
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    Infants will be assigned to the same treatment group to which mothers were assigned
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    study treatment given to mothers in 200721 study will remain.No drug will be given to the infants
    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 concerned6
    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
    Study will end when each child enrolled completes the 24 month questionnaire at either 24 months corrected age (for preterm infants) or 24 months chronological age (for term infants). Study close-out and final reporting activities will be initiated on completion of the follow-up on the last study participant.
    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 months3
    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 months3
    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: 330
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 330
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 330
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 No
    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 No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    infants born to mothers that participated in the Retosiban studies
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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)
    Not applicable
    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 Decision2014-12-12
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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