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    Summary
    EudraCT Number:2016-002118-40
    Sponsor's Protocol Code Number:PPL07
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-12-16
    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 ConcernedFinland - Fimea
    A.2EudraCT number2016-002118-40
    A.3Full title of the trial
    Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Finding Study to Evaluate the Effect of continuous infusion of Tafoxiparin as an Adjunct Treatment to Oxytocin for up to 36 hours in Term Pregnant, Nulliparous Women to treat Primary Slow Progress of Labor including prolonged latent phase and Primary Labor Arrest
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Effect of continuous infusion of Tafoxiparin to treat Primary Slow Progress of Labor including prolonged latent phase and Primary Labor Arrest
    A.4.1Sponsor's protocol code numberPPL07
    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 organisationLINK Medical Research
    B.5.2Functional name of contact pointBirgitte Loop
    B.5.3 Address:
    B.5.3.1Street AddressNorgegatan 2, plan 6
    B.5.3.2Town/ cityKista
    B.5.3.3Post code16432
    B.5.3.4CountrySweden
    B.5.4Telephone number+46703842844
    B.5.6E-mailBirgitte@linkmedical.se
    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 infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTafoxiparin Sodium
    D.3.9.1CAS number 1638190-65-9
    D.3.9.2Current sponsor codeDF01
    D.3.9.3Other descriptive nameDF01
    D.3.9.4EV Substance CodeSUB28120
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number30 to 150
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous bolus use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Slow Progress of Labor including prolonged latent phase and Primary Labor Arrest
    E.1.1.1Medical condition in easily understood language
    Abnormally difficult labor
    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 10023539
    E.1.2Term Labor abnormal
    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 dose-response relationship of tafoxiparin on the labor time defined as the time from the start of continuous infusion of tafoxiparin/placebo as an Adjunct Treatment to Oxytocin, until partus in term-pregnant, nulliparous women requiring labor augmentation due to Primary Slow Progress of Labor including prolonged latent phase and Primary Labor Arrest
    E.2.2Secondary objectives of the trial
    To assess the safety and efficacy of tafoxiparin based on the safety and secondary efficacy parameters evaluated in the protocol. PK response in pregnant women during labor
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pregnant women of ≥18 to ≤45 years of age
    2. Nulliparous
    3. Gestational age > 36 weeks + 6 days confirmed by ultrasound
    4. Experience slow progress of labor including prolonged latent phase and Primary labor arrest (according to the respective definitions)
    5. Normal CTG at inclusion
    6. Singleton pregnancy
    7. Subject is as per the discretion of the Investigator, considered healthy and able to comply with the requirements of the protocol
    8. Provision of written informed consent
    E.4Principal exclusion criteria
    Exclusion criteria:
    1. Subjects with secondary slow progress or secondary labor arrest
    2. BMI≥35 during first trimester of pregnancy
    3. Breech presentation or other abnormal presentations
    4. LGA (Large for Gestational Age) defined as ≥ to normal weight earlier diagnosed by ultrasound and documented in patient record
    5. Small for gestational age (SGA) defined as ≥-2SD to normal weight earlier diagnosed by ultrasound and documented in patient record
    6. Presence of eclampsia
    7. Severe preeclampsia, defined as severe by the [ACOG Committee Preeclampsia and Eclampsia (2002)] as preeclampsia with any or more of the following characteristics present:
    - Blood pressure of ≥160 mmHg systolic or ≥110 mmHg diastolic on two occasions at least 6 hours apart while the patient is on bed rest
    - Proteinuria of 5 g or higher in a 24-hour urine specimen or 3+ greater on two random urine samples collected at least 4 hours apart
    - Oliguria of less than 500 mL in 24 hours
    - Cerebral or visual disturbances
    - Pulmonary edema or cyanosis
    - Epigastric or right upper-quadrant pain
    - Impaired liver function
    - Thrombocytopenia
    8. HELLP syndrome (hemolysis, elevated liver enzymes, and low platelets)
    9. Clinically significant vaginal bleeding in the third trimester
    10. Diagnosed renal insufficiency
    11. Previously known coagulation disorders, including but not limited to:
    - Von Willebrand’s disease
    - Haemophilia A/B
    - Antithrombin deficiency
    - Vitamin K deficiency
    12. Previously known coagulation defects, including but not limited to:
    - Prolonged activated partial thromboplastin time (APTT)
    - Thrombocytes <100 x 109/L
    13. Current use of any drugs that interfere with hemostasis, including heparin / LMWH, non-steroidal anti-inflammatory drugs (NSAID) compounds, warfarin and vitamin K antagonists
    14. Current use, or use within the week preceding screening, of acetylsalicylic acid (ASA) compounds
    15. Previously known current infections (HIV or hepatitis)
    16. Any known history of allergy to standard heparin and/or LMWH heparin
    17. History of heparin-induced thrombocytopenia
    18. Current drug or alcohol abuse which in the opinion of the Investigator should preclude participation in the study
    19. Current participation in other clinical treatment studies
    20. Previous uterine scar (e.g. myomectomy)
    21. Labor induction
    E.5 End points
    E.5.1Primary end point(s)
    Time from start of infusion of tafoxiparin/placebo until vaginal partus
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 36 hours
    E.5.2Secondary end point(s)
    • Safety assessment
    • Time from cervical dilatation of 4 cm and progress of labor until vaginal partus
    • Proportion of women with dystocia/protracted labor defined as ≥8, 10, 12 and 14 hours of established labor (4 cm of cervical dilation to vaginal partus )
    • Proportion of women with dystocia/protracted labor defined as ≥8, 10, 12 and 14 hours from start of IMP infusion to vaginal partus
    • Proportion of women with caesarean sections
    • Proportion of women undergoing instrumental deliveries
    • Number of instrumental deliveries
    • Use of analgesia (N2O, epidural, pudendal nerve block)
    • Proportion of women with postpartum hemorrhage > 1000 ml
    • Fetal outcome measured as Apgar score (5 min) ≤ 7 points, Base Excess > -12 and referral to NICU for > 48 hours
    • Uterine hyperstimulation with fetal heart rate changes
    • Indication for referral to NICU
    • Use of Oxytocin (no.umber of mililitersls. according to instructions)
    • PK response measured between, at least 60 minutes after initiation of treatment with IMP and partus
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 36 hours
    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 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 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 trial4
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 No
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 360
    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 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 state360
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 360
    F.4.2.2In the whole clinical trial 360
    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)
    None
    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 Decision2017-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-03-05
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