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    Summary
    EudraCT Number:2023-000150-20
    Sponsor's Protocol Code Number:1
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2023-02-01
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2023-000150-20
    A.3Full title of the trial
    The effect of exercise on pharmacodynamics and pharmacokinetics of a single dose of unfractionated heparin: A randomized, controlled, cross-over study
    Effekten af fysisk aktivitet på optagelse og virkning af ufraktioneret heparin
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of exercise on function and concentrations of a single dose of unfractionated heparin
    Effekten af fysisk aktivitet på optagelse og virkning af ufraktioneret heparin
    A.4.1Sponsor's protocol code number1
    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 SponsorBispebjerg-Frederiksberg Hospital
    B.1.3.4CountryDenmark
    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 supportDepartment of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital
    B.5.2Functional name of contact pointDepartment of Clinical Pharmacology
    B.5.3 Address:
    B.5.3.1Street AddressBispebjerg Bakke 23, opgang 20C
    B.5.3.2Town/ cityCopenhagen
    B.5.3.3Post code2400
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4538635102
    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 Heparin "LEO", injektionsvæske, opløsning 5.000 IE/ml
    D.2.1.1.2Name of the Marketing Authorisation holderLEO Pharma
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 nameHeparin "LEO", injektionsvæske, opløsning 5.000 IE/ml
    D.3.4Pharmaceutical form Solution for injection in vial
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 No
    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
    Unfractionated heparin is used for the prevention and treatment of deep vein thrombosis and complications hereof
    Ufraktioneret heparin bruges til forebyggelse og behandling af dyb venetrombose og komplikationer til dette
    E.1.1.1Medical condition in easily understood language
    Unfractionated heparin is used for the prevention and treatment of deep vein thrombosis and complications hereof
    Ufraktioneret heparin bruges til forebyggelse og behandling af dyb venetrombose og komplikationer til dette
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    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 effect of a single exercise session (with both legs) on pharmacodynamics and pharmacokinetics of a single dose of subcutaneously administered unfractionated heparin.
    At undersøge om akut fysisk aktivitet kan påvirke effekt og koncentration af en enkelt dosis ufraktioneret heparin
    E.2.2Secondary objectives of the trial
    To assess the effect of a single exercise session (with one leg) on pharmacodynamics and pharmacokinetics of a single dose of subcutaneously administered unfractionated heparin, administered in the exercising vs. the non-exercising leg, respectively.
    At undersøge om akut fysisk aktivitet (med et ben) påvirkes effekt og koncentration af en enkelt dosis ufraktioneret heparin forskelligt, afhængigt af om heparin administreres i det arbejdende eller det ikke-arbejdende ben
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male between 18 and 50 years old
    • Body weight 50 kg or more
    • Body Mass Index 18.5−25 kg/m2
    • Acceptance of not drinking alcohol for 24 hours before to 24 hours after dosing of study drug
    • Acceptance of not performing physical activity for 24 hours before to 24 hours after dosing of study drug
    • Signed informed consent form
    • Mand mellem 18 og 50 år
    • Vægt over 50 kg
    • BMI 18,5-25 kg/m2
    • Accept af ikke at drikke alkohol fra 24 timer før og til 24 timer efter hver indgift af ufraktioneret heparin
    • Accept af ikke at være fysisk aktiv fra 24 timer før og til 24 timer efter hver indgift af ufraktioneret heparin
    • Underskrevet erklæring vedr. informeret samtykke
    E.4Principal exclusion criteria
    • History or sign of bleeding disorders
    • History or sign of kidney disease
    • History or sign of liver disease
    • Average systolic blood pressure <100 mmHg or >140 mmHg and/or average diastolic blood pressure <60 mmHg or >90 mmHg (average of three measurements performed at screening).
    • Daily pharmaceutical treatment
    • Contraindication to increased levels of physical activity (10)
    • Smoking or other regular use of any form of nicotine products during the study period and the previous 3 months.
    • Current or prior participation (within 3 months before screening) in other clinical trials that might affect the results of this study (judged by the investigator).
    • Previous treatment with heparins
    • Low levels of anti-thrombin (P-antitrombin(enz.) <0,80 kIU/L)
    • Tegn til eller kendt forstyrrelse i blødnings- og koagulationssystemet
    • Tegn til eller kendt nyresygdom
    • Tegn til eller kendt leversygdom
    • Systolisk blodtryk <100 mmHg eller > 150 mmHg
    • Diastolisk blodtryk <60 mmHg eller > 90 mmHg
    • Daglig medicinsk behandling
    • Rygning indenfor de seneste 3 måneder
    • Tilstande der medfører at fysisk aktivitet ikke må udføres
    • Aktuel eller nylig (indenfor 3 måneder) deltagelse i andre kliniske forsøg
    • Tidligere behandling med heparin
    • Lavt niveau af anti-thrombin (et enzym der er nødvendigt for at heparin virker og som måles via en blodprøve)
    E.5 End points
    E.5.1Primary end point(s)
    Difference between interventions in change in incremental aPTT
    Forskelle mellem interventioner i ændring i aPTT
    E.5.1.1Timepoint(s) of evaluation of this end point
    Peak aPTT for 1-8 hours after UFH injection
    Maks aPTT i 1-8 timer efter UFH injektion
    E.5.2Secondary end point(s)
    Difference between interventions in change in incremental plasma heparin
    Forskelle mellem interventioner i ændring i plasma heparin
    E.5.2.1Timepoint(s) of evaluation of this end point
    Peak plasma heparin for 1-8 hours after UFH injection
    Maks plasma heparin i 1-8 timer efter UFH injektion
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.1.6Cross over Yes
    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
    Injection of IMP subcutaneously in different legs
    E.8.2.4Number of treatment arms in the trial4
    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 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
    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 months6
    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: 15
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state15
    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 Decision2023-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-02-13
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