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    Summary
    EudraCT Number:2020-004692-40
    Sponsor's Protocol Code Number:PPL20
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-24
    Trial 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-004692-40
    A.3Full title of the trial
    An Exploratory, Open label, Randomized, Parallel-Group, Pilot Study to evaluate Safety, Tolerability and Efficacy of daily, subcutaneous tafoxiparin treatment from the time of diagnosis for up to 4 weeks, in pregnant women who are diagnosed with pre-eclampsia between the 26th and 32nd weeks of gestation.
    Studio pilota esplorativo, in aperto, randomizzato, a gruppi paralleli, volto a valutare la sicurezza, la tollerabilità e l'efficacia del trattamento giornaliero con tafoxiparin, somministrato per via sottocutanea a partire dal momento della diagnosi per un massimo di 4 settimane, in donne in gravidanza che sviluppano preeclampsia tra la 26a e la 32a settimana di gestazione
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tafoxiparin for the treatment of pre-eclampsia
    Tafoxiparin per il trattamento della preeclampsia
    A.3.2Name or abbreviated title of the trial where available
    PPL20
    PPL20
    A.4.1Sponsor's protocol code numberPPL20
    A.5.4Other Identifiers
    Name:NANumber:NA
    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 SponsorDilafor AB
    B.1.3.4CountrySweden
    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 supportDilafor AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDilafor AB
    B.5.2Functional name of contact pointCEO
    B.5.3 Address:
    B.5.3.1Street AddressFogdevreten 2A
    B.5.3.2Town/ citySolna
    B.5.3.3Post codeSE-171 65
    B.5.3.4CountrySweden
    B.5.4Telephone number0046707900207
    B.5.5Fax number0046707900207
    B.5.6E-maillena.wikingsson@dilafor.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 nameTafoxiparin
    D.3.2Product code [DF01]
    D.3.4Pharmaceutical form Concentrate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTAFOXIPARIN SODIUM
    D.3.9.1CAS number 1638190-65-4
    D.3.9.2Current sponsor codeDF01
    D.3.9.4EV Substance CodeSUB189833
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeDepolimerized heparin form, low molecular weight derived from porcine heparin
    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
    Preeclampsia diagnosed at week 26-32 of gestation.
    Preeclampsia diagnosticata tra la 26a e la 32a settimana di gestazione.
    E.1.1.1Medical condition in easily understood language
    Preeclampsia
    Preeclampsia
    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 10040444
    E.1.2Term Severe pre-eclampsia
    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
    To assess the maternal and neonatal safety, tolerability and feasibility of subcutaneous tafoxiparin treatment from the time of diagnosis for up to 4 weeks, in pregnant women who develop pre-eclampsia between the 26th and 32nd weeks of gestation.
    Valutare la sicurezza materna e neonatale, la tollerabilità e la fattibilità del trattamento sottocutaneo con tafoxiparin dal momento della diagnosi fino a 4 settimane, in donne in gravidanza che sviluppano preeclampsia tra la 26a e la 32a settimana di gestazione.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of tafoxiparin treatment on preeclampsia.
    Valutare l'efficacia del trattamento con tafoxiparin sulla preeclampsia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    i) Nulliparous pregnant women of =18 and = 45 years of age
    ii) The subject has been diagnosed with pre-eclampsia defined as: Hypertension 160/100 mmHg with proteinuria (= 2+ on urine dip-stick) or albumin/creatinine = 30 mg/mmol
    iii) The subject is planned for hospitalization
    iv) Gestational age = 26th and = 32nd weeks confirmed by ultrasound before 21st weeks of gestation
    v) Singleton pregnancy
    vi) Subject is, as per the discretion of the Investigator, able to comply with the requirements of the protocol including an ability to be present at all required controls
    vii) Subject can understand and sign an informed consent form
    viii) Provision of written informed consent
    i) Donna in gravidanza nullipara di età =18 e = 45 anni
    ii) Diagnosi di preeclampsia definita come: ipertensione 160/100 mmHg con proteinuria (= 2+ su dip-stick urinario) o albumina/creatinina = 30 mg / mmol
    iii) Previsione di ricovero ospedaliero
    iv) Età gestazionale compresa fra = 26a e = 32a settimana confermata mediante ecografia prima della 21a settimana di gestazione
    v) Gravidanza singola
    vi) Soggetto in grado, secondo il parere dello sperimentatore, di soddisfare i requisiti del protocollo inclusa la possibilità di presentarsi a tutti i controlli previsti
    vii) Soggetto in grado di comprendere e firmare un modulo di consenso informato
    viii) Presentazione del consenso informato scritto.
    E.4Principal exclusion criteria
    i) Subjects who are unable to understand the written and verbal instructions in local language
    ii) Presence of placenta previa
    iii) Pathologic CTG at inclusion
    iv) Diagnosed with Diabetes type1
    v) Presence of eclampsia
    vi) HELLP syndrome (hemolysis, elevated liver enzymes, and low platelets)
    vii) Previously known coagulation disorders (Leiden – heterozygote; OK)
    viii) Current use of any drugs that interfere with hemostasis (including heparin /LMWH, oral anti-coagulant medication, non-steroidal anti-inflammatory drugs (NSAID) compounds and vitamin K antagonists.)
    ix) Diagnosed with Essential hypertension with ongoing therapy
    x) Diagnosed with HIV or Acute hepatitis with ongoing therapy
    xi) Known history of allergy to standard heparin and/or LMWH heparin
    xii) History of heparin-induced thrombocytopenia (platelet count = 100.000)
    xiii) Current drug or alcohol abuse which in the opinion of the Investigator should preclude participation in the study.
    xiv) Subjects that are not fit for participation in the study according to the opinion of the investigator due to a concurrent disease or severe organ affection
    xv) Current participation in other interventional medicinal treatment studies
    xvi) Subject has a fear of needles which is believed by the Investigator to affect study medication compliance
    xvii) Severe pulmonary edema
    xviii) Idiopathic thrombocytopenia
    xix) Diagnosed with chronic kidney disease
    xx) Diagnosed with chronic hepatic disorders
    xxi) Diagnosed with systemic lupus erythematosus
    xxii) Diagnosed with antiphosphlipid syndrome
    i) Soggetti non in grado di comprendere le istruzioni scritte e verbali nella lingua locale
    ii) Presenza di placenta previa
    iii) CTG patologico all'inclusione
    iv) Diagnosi di Diabete di tipo 1
    v) Presenza di eclampsia
    vi) Sindrome HELLP (emolisi, aumento degli enzimi epatici e piastrine basse)
    vii) Disturbi della coagulazione precedentemente noti (Leiden - eterozigote; OK)
    viii) Assunzione attuale di farmaci che interferiscono con l'emostasi (tra cui eparina/EBPM, anticoagulanti orali, antinfiammatori non steroidei (FANS), composti e antagonisti della vitamina K)
    ix) Diagnosi di Ipertensione essenziale con terapia in corso
    x) Diagnosi di epatite acuta o HIV con terapia in corso
    xi) Anamnesi nota di allergia all'eparina standard e/o all'eparina a basso peso molecolare (EBPM)
    xii) Anamnesi di trombocitopenia indotta da eparina (conta piastrinica = 100.000)
    xiii) Attuale tossicodipendenza (droghe o alcol) che, secondo il parere dello sperimentatore, dovrebbe precludere la partecipazione allo studio
    xiv) Soggetti non idonei a partecipare allo studio secondo il parere dello sperimentatore a causa di una malattia concomitante o di severa compromissione d'organo
    xv) Attuale partecipazione ad altri studi interventistici farmacologici
    xvi) Paura degli aghi da parte del soggetto che, secondo il parere dello sperimentatore, potrebbe influire sulla compliance al trattamento sperimentale
    xvii) Edema polmonare grave
    xviii) Trombocitopenia idiopatica
    xix) Diagnosi di malattia renale cronica
    xx) Diagnosi di disturbi epatici cronici
    xxi) Diagnosi di lupus eritematoso sistemico
    xxii) Diagnosi di sindrome da antifosfolipidi
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability will be evaluated through the frequency and character of adverse events and serious adverse events, complete and symptom-directed physical evaluations, vital signs, safety blood samples (hematology and clinical chemistry) and rate of withdrawals from the study and/or from the study medication.
    La sicurezza e la tollerabilità saranno valutate attraverso la frequenza e il carattere di eventi avversi ed eventi avversi gravi, valutazioni fisiche complete e orientate ai sintomi, segni vitali, campioni di sangue di sicurezza (ematologia e chimica clinica) e tasso di ritiro dallo studio e/o dal farmaco in studio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    NA
    NA
    E.5.2Secondary end point(s)
    i) Change in diastolic blood pressure from baseline to end of treatment and at 8 weeks follow-up control
    ii) Change in Aortic Pulse Wave Velocity (PWV) measured by carotid–femoral PWV (cfPWV) at baseline, after 2, 7 and 28 days of treatment, and at 8 weeks follow-up control
    iii) Change in cardiac output
    iv) Change in soluble Fms-like tyrosine kinase 1 (sFlt-1)
    v) Change in Placental Growth Factor (PlGF)
    vi) Change in sFlt-1/PlGF ratio
    vii) Days of maintained pregnancy
    viii) Extent of anti-hypertensive treatment (number of drugs and doses)
    ix) Fetal growth changes estimated by ultrasound
    x) Change in umbilical cord blood flow
    xi) Change in uterine artery BLOOD FLOW
    xii) Proportion of subjects with abruptio placenta
    xiii) Proportion of infants with birth weight =5th percentile
    xiv) Proportion of infants with birthweight in 6th - 10th percentile
    xv) Proportion of subjects with fetal loss after 28 weeks of gestation
    xvi) Proportion of subjects with eclampsia
    xvii) Proportion of subjects with oliguria
    xviii) Proportion of subjects submitted to ICU during the study
    xix) Proportion of subjects undergoing preterm delivery
    xx) Proportion of subjects undergoing caesarean sections (CS)
    xxi) Maternal and fetal Indications for CS
    xxii) Proportion of subjects undergoing instrumental deliveries (vacuum extraction (VE)/forceps delivery)
    xxiii) Proportion of subjects with Postpartum Hemorrhage (PPH) > 2000 ml
    xxiv) Fetal outcome measured as Birth weight, Apgar score, Acidosis (pH<7.10) and/or Base Excess < -12 mmol/L arterial or venous in umbilical cord blood
    xxv) Indication for referral to NICU.
    i) Variazione della pressione diastolica dal basale alla fine del trattamento e dopo 8 settimane di controllo
    ii) Variazione della velocità dell'onda del polso aortica (PWV) misurata dalla PWV carotide-femorale (cfPWV) al basale, dopo 2, 7 e 28 giorni di trattamento e dopo 8 settimane di controllo
    iii) Variazione della gittata cardiaca
    iv) Variazione della tirosin chinasi 1 solubile simile a Fms (sFlt-1)
    v) Modifica del fattore di crescita placentare (PlGF)
    vi) Variazione del rapporto sFlt-1 / PlGF
    vii) Giorni di gravidanza mantenuta
    viii) Entità del trattamento antipertensivo (numero di farmaci e dosi)
    ix) Cambiamenti della crescita fetale stimati mediante ultrasuoni
    x) Modifica del flusso sanguigno del cordone ombelicale
    xi) Variazione del flusso sanguigno dell'arteria uterina
    xii) Proporzione di soggetti con distacco di placenta
    xiii) Proporzione di neonati con peso alla nascita =5° percentile
    xiv) Proporzione di neonati con peso alla nascita nel 6°-10° percentile
    xv) Proporzione di soggetti con perdita fetale dopo 28 settimane di gestazione
    xvi) Proporzione di soggetti con eclampsia
    xvii) Proporzione di soggetti con oliguria
    xviii) Proporzione di soggetti sottoposti a terapia intensiva durante lo studio
    xix) Proporzione di soggetti sottoposti a parto pretermine
    xx) Proporzione di soggetti sottoposti a taglio cesareo
    xxi) Indicazioni materne e fetali per taglio cesareo
    xxii) Proporzione di soggetti sottoposti a parto strumentale (estrazione a vuoto (VE) / parto con pinza)
    xxiii) Proporzione di soggetti con Emorragia Postpartum (PPH)> 2000 ml
    xxiv) Esito fetale misurato come peso alla nascita, punteggio di Apgar, acidosi (pH <7.10) e/o eccesso di basi <-12 mmol/L arterioso o venoso nel sangue del cordone ombelicale
    xxv) Indicazione per il deferimento alla terapia intensiva neonatale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From start of treatment until 8 weeks after discharge.
    Dall'inizio del trattamento fino a 8 settimane dopo la dimissione.
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Normale pratica clinica
    Normal clinical practice
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    LVLS
    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 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: 23
    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 Yes
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 23
    F.4.2.2In the whole clinical trial 23
    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)
    Subsequent to the final follow-up of the subject, each subject will be treated in accordance with standard clinical practice and appropriate care.
    Successivamente al follow-up finale del soggetto, ogni soggetto sarà trattato secondo la pratica clinica standard e le cure appropriate.
    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 Decision2021-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-30
    P. End of Trial
    P.End of Trial StatusOngoing
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