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    Summary
    EudraCT Number:2017-005021-21
    Sponsor's Protocol Code Number:PIPIN
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2018-08-02
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-005021-21
    A.3Full title of the trial
    A feasibility study investigating pravastatin for the prevention of preterm birth in women
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A feasibility study investigating pravastatin for the prevention of preterm birth in women
    A.3.2Name or abbreviated title of the trial where available
    PIPIN
    A.4.1Sponsor's protocol code numberPIPIN
    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 of Edinburgh
    B.1.3.4Country
    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 supportTommy's Charity
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Edinburgh
    B.5.2Functional name of contact pointSonia Whyte
    B.5.3 Address:
    B.5.3.1Street AddressSimpson Centre (Repro Health) S7129
    B.5.3.2Town/ city51 Little France Crescent
    B.5.3.3Post codeEH16 4SA
    B.5.4Telephone number0131 242 2693
    B.5.5Fax number0131 242 2686
    B.5.6E-mailsonia.whyte@ed.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorNHS Lothian
    B.1.3.4CountryUnited Kingdom
    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 supportTommy's Charity
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Pravastatin Sodium
    D.2.1.1.2Name of the Marketing Authorisation holderTeva UK
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namePravastatin Sodium
    D.3.4Pharmaceutical form 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 INNPravastatin Sodium
    D.3.9.1CAS number 81093-37-0
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number to 40
    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, hard
    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
    Preterm Birth
    E.1.1.1Medical condition in easily understood language
    Delivery of a baby between 24+0 and 36+6 weeks gestation
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10032405
    E.1.2Term Other preterm infants
    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
    This study is testing whether women between 28+0 and 35+6 weeks pregnant who come to hospital with signs and/or symptoms of preterm labour would be willing to take a medication (pravastatin) or placebo in a blinded fashion for 7 days.
    E.2.2Secondary objectives of the trial
    1) To see if pravastatin when compared to placebo is associated with a longer time to delivery, fewer contractions, and lower markers of inflammation in both the mother and fetus in women with preterm labour.
    2) To see if pravastatin when compared to placebo improves outcomes for both mother and baby.
    3) To monitor the average time from when a participant is first established as eligible for the trial to when they get the first dose of study drug.
    4) To establish how acceptable the study is to participants after completing the protocol.
    5) To measure compliance with treatment.
    6) To establish whether the blood concentrations of study drug in this population are the same as currently published data.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Gestation between 28+0 and 35+6 weeks inclusive (based on dating scan obtained at ≤ 16 weeks gestation)
    • Singleton pregnancy
    • Aged 16 years or above
    • Not previously recruited to this study in this pregnancy
    • Intact membranes
    • A positive fetal fibronectin test OR a short cervical length ( 15mm) on ultrasound examination OR cervical dilation ≥ 3cm and less than fully dilated
    • Uterine activity defined as ≥ 1 palpable contraction over 20 minutes of CTG monitoring.
    • No major congenital anomalies evident on the 20 week anomaly scan, or any further anomaly scans performed subsequently. If an anomaly is present, this should be classified as per ICD-10 codes and minor anomalies discussed for inclusion on a case by case approach involving the clinical team, the PI and the participant.
    • Not demonstrating any of the exclusion criteria
    E.4Principal exclusion criteria
    • • Immediate delivery deemed necessary for fetal or maternal reasons as determined by a senior clinician.
    • Pre-labour, preterm rupture of membranes in the index pregnancy
    • Obstetric Cholestasis as defined by RCOG (RCOG Green-Top Guideline, Number 43)
    • Established severe pre-eclampsia or HELLP syndrome as defined by NICE guidance (Hypertension in pregnancy: diagnosis and management | Guidance and guidelines | NICE n.d.)
    • Known History of hepatic or renal impairment
    • Ingestion of drugs thought to alter the pharmacokinetics or efficacy of statins, including erythromycin and/or nifedipine.
    • Taking any one of the prohibited drugs as listed the SmPC and in 5.7.3
    • Lactose intolerance (due to excipient in Pravastatin and placebo)
    • Current or previous alcohol misuse
    • Personal or first degree relative with heritable muscle disorders
    • Participating in another CTIMP trial
    E.5 End points
    E.5.1Primary end point(s)
    Recruitment, retention and outcome collection of 40 Participants in established preterm labour.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Recruitment of participant number 40
    E.5.2Secondary end point(s)
    1) Retention, adherence and ability to collect clinical outcomes from participants
    2) Time to delivery from presentation and gestation at delivery
    3) Contraction frequency from presentation to delivery or cessation of regular uterine activity.
    4) Maternal markers of inflammation including, but not limited to: IL-6, IL-10, IL-13, IL-17, TNFa, IL-1RA, sTNF-RI,sTNF-R2, and HO-1, as well as levels of the soluble IL-6R and the inhibitor spg130 (abbreviated hereafter to ‘Inflammatory Profile’)
    5) Fetal measures of inflammation (cord IL-1, IL-6, IL-8) as well as levels of sIL-6R and sgp130.
    6) Adverse events (maternal and fetal)
    7) Time from ‘time first seen’ to delivery of first dose of trial medication
    8) Compliance with 7 days of blinded treatment
    9) Acceptability of the trial to those who have participated
    10) Pharmacokinetic parameters as compared with current published data
    11) Maternal outcomes:
    a. Proven maternal infection
    b. Safety of intervention to mother (self-reported AEs and biochemical monitoring of liver function tests and creatinine
    kinase).
    c. Pre-labour ROM
    d. Duration, location and level of care of hospital stay following presentation with suspected preterm labour AND
    following delivery.
    12) Neonatal outcomes:
    a. Neonatal morbidity (a composite measure of neonatal outcomes, including neurological, respiratory,
    gastrointestinal and cardiological measures, gestation and weight at birth, place and length of stay following delivery,
    evidence of sepsis and feeding type.)
    b. Neonatal mortality
    c. Safety of intervention
    E.5.2.1Timepoint(s) of evaluation of this end point
    At estimated date of delivery + 28 days for the last participant recruited
    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 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) 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Placebo-controlled
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS (Expected data of delivery plus 28 days)
    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: 3
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 3
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 37
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 No
    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 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 40
    F.4.2.2In the whole clinical trial 40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The participant will discontinue the intervention following 7 days of treatment or delivery, whichever occurs soonest.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2019-11-29
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