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    Summary
    EudraCT Number:2019-000620-17
    Sponsor's Protocol Code Number:PPL17
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-03-15
    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 ConcernedSweden - MPA
    A.2EudraCT number2019-000620-17
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Proof of Concept
    Study (section A) with a conditional dose finding follow up (Section B) to Evaluate the
    Efficacy on Cervical ripening, Safety, Tolerability and dose response of Subcutaneously
    Administered Tafoxiparin in Term Pregnant, Nulliparous Women with an unripe cervix
    undergoing Labor Induction.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy, Safety, Tolerability and dose response of Subcutaneously Administered Tafoxiparin to induce labor in Term Pregnant, Nulliparous Women with an unripe cervix
    A.4.1Sponsor's protocol code numberPPL17
    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 code17165
    B.5.3.4CountrySweden
    B.5.4Telephone number+46707900207
    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 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 1638190-4
    D.3.9.2Current sponsor codeDF01
    D.3.9.3Other descriptive nameDF01
    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 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 Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Induction of labor in pregnant women with unripe cervix
    E.1.1.1Medical condition in easily understood language
    Labor Induction
    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 10055563
    E.1.2Term Labor induction
    E.1.2System Organ Class 100000004865
    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 Efficacy of tafoxiparin on cervical ripening
    E.2.2Secondary objectives of the trial
    To assess the maternal and neonatal safety, tolerability and dose
    response of tafoxiparin as a supplement therapy in term pregnant,
    nulliparous women with an unripe cervix undergoing labor
    induction
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    i)Pregnant women of ≥18 and ≤ 64 years of age
    ii) Nulliparous
    iii) Unripe cervix with ≤ 4points according to
    Bishop/Westin score (0-10 points scale)
    iv) Planned for labor induction after 4-7 days of IMP
    treatment
    Examples of diagnosis as a basis for induction:
    Post term pregnancy (40-41 weeks of gestation)
    Gestational diabetes
    Diabetes type 1 - well controlled
    Pre-eclampsia (BP diastolic <100, systolic <140)
    Hypertension - well controlled
    Hepatosis (without clinically significantly elevated
    serum bile acids)
    Maternal age ≥ 40 years
    Humanitarian-psycho social reasons
    Oligohydramnios
    v) Gestational age > 37 weeks confirmed by ultrasound
    before 21 weeks of gestation
    vi) Singleton pregnancy
    vii) 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
    viii) Subject can understand and sign an informed form
    ix) Provision of written informed consent
    E.4Principal exclusion criteria
    i) Subjects who are unable to understand the written and
    verbal instructions in local language
    ii) Breech presentation and other abnormal fetal
    presentations
    iii) Previous uterine scar
    iv)Spontaneous rupture of membranes at inclusion
    v) Pathologic CTG at inclusion
    vi) Fetal estimated weight > 2SD of normal fetal
    estimated weight earlier diagnosed by ultrasound and
    documented in patient record
    vii) Mother’s BMI > 35 at early pregnancy
    viii) Known IUGR defined as ≤ 2SD of normal
    ix) Presence of eclampsia
    x) Severe Pre-eclampsia
    xi) HELLP syndrome (hemolysis, elevated liver enzymes,
    and low platelets)
    xii) Clinically significant vaginal bleeding in need of
    hospitalization in the third trimester
    xiii) Placenta previa
    xiv) Previously known coagulation disorders (Leiden,
    heterozygote - OK)
    xv) Treatment with a heparin/LMWH product during the previous six months
    xvi) 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.)
    xvii) Current use of acetylsalicylic acid (ASA) compounds
    or use within the week preceding inclusion
    xviii) Diagnosed with HIV or Acute hepatitis
    xix) Known history of allergy to standard heparin
    and/or LMWH heparin
    xx) History of heparin-induced thrombocytopenia
    xxi) Current drug or alcohol abuse which in the opinion
    of the Investigator should preclude participation in
    the study.
    xxii) Current participation in other interventional medicinal
    treatment studies
    xxiii) Subject has a fear of needles which is believed by the
    Investigator to affect study medication compliance
    xxiv)Any relevant condition, laboratory value or concomitant medication which, in the opinion of the investigator, makes the subject unsuitable for entry into the study
    E.5 End points
    E.5.1Primary end point(s)
    Cervical ripening rate during up to the first seven days of treatment, measured by Bishop score
    E.5.1.1Timepoint(s) of evaluation of this end point
    During up to the first seven days of treatment
    E.5.2Secondary end point(s)
    Secondary Efficacy endpoints include:
    i) Time from start of treatment to increase in Bishop score of ≥ 2 points or spontaneous onset of labor, whichever comes first
    ii) Time from start of treatment to increase in Bishop score of ≥ 3 points or spontaneous onset of labor, whichever comes first
    iii) Time from start of treatment to increase in Bishop score of ≥ 4 points or spontaneous onset of labor, whichever comes first
    iv) Cervical ripening as measured by change from baseline to end of treatment in Bishop/Westin
    v) Time from onset of labor to partus. Onset of labor is defined as last record of 4 cm cervical dilatation visualized in the partogram and progress of labor or last record of 4 cm of cervical dilatation in combination with amniotomy and intravenous administration oxytocin
    vi) Proportion of women with established labor
    ≤ 6 hours
    vii) proportion of women with established labor time of _< 8 hours
    viii) Proportion of women with established labor
    ≥ 12 hours
    ix) Total dosages of study drug (IMP)
    x) Proportion of women with spontaneous labor (response group I)
    xi) Proportion of women with a ripe cervix (response group I+II)
    xii) Proportion of women in response groups (I-IV)


    Secondary Safety and tolerability endpoints include:
    i) Proportion of patients undergoing caesarean sections (CS)
    ii) Indications for CS
    iii) Proportion of patients undergoing instrumental deliveries (vacuum extraction (VE)/forceps delivery)
    iv) Indications for VE and forceps deliveries
    v) 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
    vi) Indication for referral to neonatal intensive care unit (NICU)
    vii) Proportion of infants staying in the NICU for > 48 hours.
    viii) Uterine hyper stimulation in demand of tocolytic treatment
    ix) Proportion of patients with Postpartum Hemorrhage (PPH) > 2000 ml
    E.5.2.1Timepoint(s) of evaluation of this end point
    From start of treatment until discharge
    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 Yes
    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 trial6
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    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
    E.8.9.2In all countries concerned by the trial years3
    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: 334
    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 No
    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 state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 334
    F.4.2.2In the whole clinical trial 334
    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.
    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 Decision2019-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-12-30
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