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    Summary
    EudraCT Number:2014-003138-18
    Sponsor's Protocol Code Number:UCC-Strider
    National Competent Authority:Ireland - HPRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-08-13
    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 ConcernedIreland - HPRA
    A.2EudraCT number2014-003138-18
    A.3Full title of the trial
    STRIDER Ireland: A Randomised Controlled Trial of Sildenafil Therapy In Dismal Prognosis Early‐Onset Intrauterine Growth Restriction
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STRIDER Ireland
    A.4.1Sponsor's protocol code numberUCC-Strider
    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 SponsorUniversity College Cork
    B.1.3.4CountryIreland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHealth Research Board (HRB)
    B.4.2CountryIreland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity College Cork
    B.5.2Functional name of contact pointAlice Power
    B.5.3 Address:
    B.5.3.1Street AddressINFANT Centre,
    B.5.3.2Town/ cityCork University Maternity Hospital, Wilton, Cork
    B.5.3.3Post coden/a
    B.5.3.4CountryIreland
    B.5.4Telephone number00353214205064
    B.5.6E-mailalice.power@ucc.ie
    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 Sildenafil Activis
    D.2.1.1.2Name of the Marketing Authorisation holderActivis Ireland
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameSildenafil Citrate
    D.3.4Pharmaceutical form Capsule, soft
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboCapsule, soft
    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
    Severe early - onset Intrauterine Growth Restriction (IUGR), (also referred to as Fetal growth restriction) diagnosed between 22+0 and 29+6 gestational age. IUGR is defined as an estimated fetal weight <10th centile OR Abdominal circumference <10th centile AND absent or reversed end diastolic flow in the umbilical artery.
    E.1.1.1Medical condition in easily understood language
    IUGR occurs when the placenta fails to develop correctly limiting the transfer of nutrients and oxygen resulting in fetal malnutrition and hypoxia which are considered untreatable in utero.
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10070532
    E.1.2Term Fetal growth restriction
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The overarching aim is to determine whether maternal treatment with oral sildenafil citrate improves perinatal outcomes in pregnancies complicated by severe early-onset IUGR without increasing risks to the mother.

    This study has a specific objective to evaluate the clinical efficacy of sildenafil i.e. its ability to lead to a delay of a clinical indication for delivery on fetal grounds by at least one week. The other specific objective is to add to our understanding of the mechanism of action of sildenafil by monitoring changes in the maternal, utero‐placental and fetal circulation.
    E.2.2Secondary objectives of the trial
    *Investigate impact on fetal growth & well‐being by comparing differential effect on the vascular resistance in the uterine arteries, umbilical, fetal middle cerebral artery and fetal ductus venosus & differences in birth weight centiles in infants treated in-utero with sildenafil & placebo
    *Examine, in collaboration with an international consortium, the hypothesis that sildenafil increases rate of infant survival free of major handicap compared to placebo
    *Report frequency of adverse & serious adverse events associated with sildenafil use
    *Investigate the impact on maternal cardiovascular parameters by measuring maternal heart rate & peripheral blood pressure before & after administration of IMP
    *Elucidate the precise mechanism & location of action of sildenafil in pregnancy by investigating the effects of sildenafil on omental (representative of the wider maternal systemic vasculature), myometrial (uterine vasculature) & chorionic plate artery (placental vasculature) reactivity
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    For some participants in selected investigating sites the study may also involve additional maternal blood samples and collection of maternal blood samples and the placenta after birth.

    1. Angiogenic Profiling
    The effect of sildenafil upon maternal angiogenic markers will be assessed by maternal blood sampling. Blood will be drawn at randomisation; 2 hours post first treatment and every 3-4 days up to 2 weeks post randomisation (maximum of 6 collections per participant). Each sample will be of 30ml, with a total of up to 180ml drawn over the length of the study. Blood samples will be taken by a clinician trained in venepuncture and processed and stored in accordance with the specific Standard Operating Procedure (SOP). Samples will then be sent to INFANT at University College Cork (UCC) for analysis. Angiogenic marker studies will be coordinated by Professor Louise Kenny (UCC).

    2. Placental Biobanking
    Each participant will be requested to donate their placenta after delivery. This process will not preclude formal histopathological assessment if this is deemed necessary by the attending physician. Placental samples will be prepared and transferred to INFANT at University College Cork (UCC) for biobanking in accordance with the HTA, under the supervision of Professor Louise Kenny (UCC). Future funding will be sought for functional placental studies. The laboratory preparation of placental samples is covered in a specific SOP.

    3. Individual Patient Data meta-analysis
    We are planning to conduct an Individual Patient Data (IPD) meta‐ analysis in collaboration with the STRIDER consortium across the world. This prospective analysis will address the issues of sildenafil effectiveness and safety focusing on substantive short and long term clinical outcomes. Separate protocols will be developed for this work. The data capture an analysis will be coordinated by CTU University of British Columbia, Department of Obstetrics & Gynaecology.
    E.3Principal inclusion criteria
    All legally adult women with a diagnosis of a pregnancy affected by severe early-onset IUGR between 22+0 and 29+6 weeks of gestation will be considered for randomisation.

    Inclusion criteria:
    • Singleton pregnancy with severe, early-onset IUGR between 22+0 and 29+6 AND a clinical decision to manage expectantly
    • IUGR is defined as an estimated fetal weight <10th centile OR Abdominal circumference<10th centile AND absent or reversed end diastolic flow in the umbilical artery
    • 16 years of age or older
    • Consent to take part in the trial
    E.4Principal exclusion criteria
    • Multiple pregnancy
    • Known or suspected structural or chromosomal fetal abnormality
    • Maternal illness (such as pre-eclampsia), which is expected to require delivery for maternal reasons within 72 hours
    • Maternal wish not to have active management of the pregnancy, such as a decision to have termination of pregnancy
    • Inability to give informed consent
    • Cocaine use
    • Contraindication to sildenafil therapy, e.g. known maternal cardiac disease, left ventricular outflow tract obstruction, concomitant treatment with nitrates or previous allergy to sildenafil.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is:
    To determine whether sildenafil compared to placebo therapy delays the need to deliver a severely growth restricted fetus by a minimum of one week.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This endpoint will be evaluated from delivery/postnatal data.
    E.5.2Secondary end point(s)
    Infant endpoints include:

    1. gestational age at birth
    2. survival to discharge
    3. birth weight centile
    4. length of admission on the Neonatal Intensive Care Unit
    5. oxygen dependency at day 28 and 36 weeks corrected age
    6. necrotising enterocolitis
    7. retinopathy of prematurity
    8. significant (grade III/IV) cerebral haemorrhage detected by cerebral ultrasound
    9. number of doses of surfactant
    10. ventilator days
    11. supplemental oxygen days
    12. number of days to full feeds

    Maternal endpoints include:

    1. mode of delivery
    2. standardised blood pressure and pulse monitoring during treatment
    3. pre‐eclampsia
    4. postpartum haemorrhage
    5. recording of the side effects e.g. headache, facial flushing
    6. in-patient postnatal stay
    E.5.2.1Timepoint(s) of evaluation of this end point
    These endpoints will be evaluated from delivery/postnatal data and neonatal data.
    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 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 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 concerned4
    E.8.5The trial involves multiple Member States No
    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
    The trial ends when the last enrolled mother/surviving infant are discharged from hospital, or baby reaches the expected date of birth, whichever is later. However, all known SAEs will be collected until the end of the data collection for the last randomised woman/baby.
    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 months0
    E.8.9.1In the Member State concerned 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: 5
    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: 5
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 107
    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 state112
    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 is an expectation that, in future, funding will be secured for long term follow-up of all survivors to contribute to the international IPD meta-analysis. This is described in the Patient Information Leaflet. To this end, the Trial Management will develop plans to stay in contact will all trial participants by regular communication as appropriate (newsletters, text messages, emails).
    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 Decision2015-10-09
    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 StatusPrematurely Ended
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