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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2023-000170-97
    Sponsor's Protocol Code Number:2023-01-1200-01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2023-01-30
    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 ConcernedGermany - BfArM
    A.2EudraCT number2023-000170-97
    A.3Full title of the trial
    A single dose of apixaban for the prevention of thrombotic events in the context of long-distance flights
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A single dose of apixaban for the prevention of thrombotic events in the context of long-distance flights
    A.3.2Name or abbreviated title of the trial where available
    DANCE FLIGHT
    A.4.1Sponsor's protocol code number2023-01-1200-01
    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 SponsorLMU Universitätsklinikum München
    B.1.3.4CountryGermany
    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 supportDFG - Deutsche Forschungsgemeinschaft (in preparation)
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportLMUExcellence Investitionsfund
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLMU Universitätsklinikum München
    B.5.2Functional name of contact pointClinical Trial Management
    B.5.3 Address:
    B.5.3.1Street AddressMarchioninistr. 15
    B.5.3.2Town/ cityMunich
    B.5.3.3Post code81377
    B.5.3.4CountryGermany
    B.5.4Telephone number4989440052305
    B.5.5Fax number4989440052410
    B.5.6E-mailE.Luesebrink@med.uni-muenchen.de
    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.3.4Pharmaceutical form Capsule, hard
    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 INNApixaban
    D.3.9.1CAS number 503612-47-3
    D.3.9.4EV Substance CodeSUB25425
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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
    Symptomatic leg vein thrombosis
    E.1.1.1Medical condition in easily understood language
    Vein thrombosis of the leg
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10051055
    E.1.2Term Deep vein thrombosis
    E.1.2System Organ Class 10047065 - Vascular disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the trial is to test whether the preventive use of apixaban 2.5 mg can significantly reduce the incidence of clinically relevant leg vein thrombosis during long-haul flights.
    Primäres Ziel der Studie ist es zu testen, ob die präventive Einnahme von Apixaban 2,5 mg das Auftreten klinisch relevanter Beinvenenthrombosen im Rahmen von Langstreckenflügen signifikant reduzieren kann.
    E.2.2Secondary objectives of the trial
    Secondarily, it is tested whether preventive use of apixaban 2.5 mg can significantly reduce the incidence of clinically relevant and non-relevant leg vein thrombosis in the context of long-haul flights. In addition, the safety profile of apixaban will be investigated in the context of its use as drug thromboprophylaxis in the context of long-haul flights, specifically the occurrence of any bleeding (BARC ≥ 1), which is mapped as a safety endpoint in the study.
    Sekundär wird getestet, ob die präventive Einnahme von Apixaban 2,5 mg das Auftreten klinisch relevanter und nicht relevanter Beinvenenthrombosen im Rahmen von Langstreckenflügen signifikant reduzieren kann. Klinisch nicht relevante Beinvenenthrombosen, auch als inapparent bezeichnet, sind dabei jene Beinvenenthrombosen, die vollständig asymptomatisch verlaufen und lediglich sonographisch nachgewiesen werden können.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written, signed and dated electronic informed consent to participate in the clinical trial
    - Legally competent male and female subjects
    - Age ≥ 18 years
    - Long-haul flight to be completed (≥6 h each way)
    - Planned return trip within 4 weeks of departure date
    Potentially pregnant/pregnant women (as per CTFG V1.1 Sept 2020):
    - Willingness to perform a total of three high-sensitivity urine pregnancy tests (25 mIU/ml for hCG): (1) prior to first single dose of investigational medication (apixaban 2.5 mg or placebo) on outbound flight as part of baseline visit, (2) prior to second single dose of investigational medication (apixaban 2.5 mg or placebo) on return flight, and (3) as part of final visit.
    - Willingness to comply with highly effective contraceptive methods according to CFTG V1.1 Sept 2020 during study participation and until one week after the second single dose of apixaban at return flight.
    - Permission to follow up on pregnancies that occur during study participation.
    - Schriftliche, unterschriebene und datierte in elektronischer Form Einwilligung zur Teilnahme an der klinischen Prüfung nach vorheriger schriftlicher und mündlicher Aufklärung
    - Entscheidungsfähige männliche und weibliche Probanden
    - Alter ≥ 18 Jahre
    - Zu absolvierender Langstreckenflug (≥6h pro Strecke)
    - Geplante Rückreise innerhalb von 4 Wochen nach Abflugtag
    Potenziell schwangere /schwanger werdende Frauen (gemäß CTFG V1.1 Sept. 2020):
    - Bereitschaft zur Durchführung von insgesamt drei hochsensitiven Urin Schwangerschaftstest (25 mIU/ml für hCG): (1) Vor der ersten Einmaleinnahme der Prüfmedikation (Apixaban 2,5 mg oder Placebo) bei Hinflug im Rahmen der Baseline-Visite, (2) vor der zweiten Einmaleinnahme der Prüfmedikation (Apixaban 2,5 mg oder Placebo) bei Rückflug und (3) im Rahmen der Abschlussvisite
    - Bereitschaft zur Beachtung hoch effektiver Maßnahmen der Kontrazeption gemäß CFTG V1.1 Sept. 2020 während der Studienteilnahme und bis eine Woche nach der zweiten Einmalgabe von Apixaban bei Rückflug.
    - Erlaubnis zur Nachverfolgung von Schwangerschaften, die während der Studienteilnahme auftreten
    E.4Principal exclusion criteria
    - Taking any antiplatelet therapy and anticoagulation (including all direct oral anticoagulants (DOAKS), vitamin K antagonists, unfractionated and low molecular weight heparins)
    - Lesions or clinical situations if considered a significant risk factor for major bleeding. This includes, but is not limited to, acute or recent gastrointestinal ulceration; malignant neoplasms with high bleeding risk; recent brain or spinal cord injury; recent brain, spinal cord, or eye surgery; recent intracranial hemorrhage; known or suspected esophageal varices; arteriovenous malformations; vascular aneurysms; or major intraspinal or intracerebral vascular abnormalities
    - Hypersensitivity to the active ingredient or any of the other ingredients of all study preparations (verum and placebo).
    - No oral medication intake possible at study inclusion, e.g. due to dysphagia of any form, inserted gastrointestinal tube, etc.
    - Known severely impaired renal function
    - Known severe/refractory arterial hypertension (systolic arterial blood pressure >180mmHg)
    - Acute or clinically relevant bleeding within the last 3 months.
    - Any blood donation / blood loss of more than 500 ml within the last 3 months.
    - Liver disease associated with coagulopathy and a clinically relevant risk of bleeding
    - Surgeries and invasive procedures within the last 3 months
    - Known antiphospholipid-syndrome
    - Pregnant and breastfeeding women
    - Participation in another interventional study within the last four weeks or five half-lives of the investigational drug in the other interventional study, whichever is longer
    - Placement in an institution due to a court or official order
    - Taking undisclosed/unrecommended concomitant medications (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, nonsteroidal anti-inflammatory drugs, systemic treatment with potent inhibitors of both CYP3A4 and P-gp, such as azole antifungals (e.g. E.g., ketoconazole, itraconazole, voriconazole, and posaconazole) and HIV protease inhibitors (e.g., ritonavir)).
    - Einnahme jeglicher antithrombozytärer Therapie und Antikoagulation (einschließlich aller direkter oraler Antikoagulantien (DOAKS), Vitamin-K-Antagonisten, unfraktionierter und niedermolekularer Heparine)
    - Läsionen oder klinische Situationen, falls sie als signifikanter Risikofaktor für eine schwere Blutung angesehen werden. Dies umfasst u.a. akute oder kürzlich aufgetretene gastrointestinale Ulzerationen, maligne Neoplasien mit hohem Blutungsrisiko, kürzlich aufgetretene Hirn- oder Rückenmarksverletzungen, kürzlich erfolgte chirurgische Eingriffe an Gehirn, Rückenmark oder Augen, kürzlich aufgetretene intrakranielle Blutungen, bekannte oder vermutete Ösophagusvarizen, arteriovenöse Fehlbildungen, vaskuläre Aneurysmen oder größere intraspinale oder intrazerebrale vaskuläre Anomalien
    - Überempfindlichkeit gegen den Wirkstoff oder einen der sonstigen Bestandteile aller Prüfpräparate (Verum und Placebo)
    - Zum Studieneinschluss keine orale Medikamenteneinnahme möglich, z.B. aufgrund von Schluckstörungen jeglicher Form, einliegender Magen-/Darmsonde etc.
    - Bekannt hochgradig eingeschränkte Nierenfunktion
    - Bekannte schwere / therapierefraktäre arterielle Hypertonie (systolischer arterieller Blutdruck >180mmHg)
    - Akute oder binnen der letzten 3 Monate stattgehabte klinisch relevante Blutung
    - Jede Blutspende / jeder Blutverlust von mehr als 500 ml binnen der letzten 3 Monate
    - Lebererkrankungen, die mit einer Koagulopathie und einem klinisch relevanten Blutungsrisiko verbunden sind
    - Operationen und invasive Eingriffe binnen der letzten 3 Monate
    - Bekanntes Antiphospholipid-Syndrom
    - Schwangere und stillende Mütter
    - Teilnahme an einer anderen interventionellen Studie binnen der letzten vier Wochen oder fünf Halbwertszeiten des Prüfpräparats der anderen interventionellen Studie, je nachdem, was länger ist
    - Unterbringung in einer Anstalt aufgrund gerichtlicher oder behördlicher Anordnung
    - Einnahme nicht angezeigter / nicht empfohlener Begleitmedikation (selektive Serotonin-Wiederaufnahmehemmer, Serotonin-Noradrenalin-Wiederaufnahmehemmer, nichtsteroidale Antirheumatika, systemische Behandlung mit starken Inhibitoren von sowohl CYP3A4 als auch P-gp, wie Azol-Antimykotika (z.B. Ketoconazol, Itraconazol, Voriconazol und Posaconazol) und HIV-Protease-Inhibitoren (z.B. Ritonavir))
    E.5 End points
    E.5.1Primary end point(s)
    The occurrence of clinically relevant leg vein thrombosis.
    Das Auftreten klinisch relevanter Beinvenenthrombosen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within two weeks after arrival of the return flight.
    Binnen zwei Wochen nach Ankunft bei Rückflug.
    E.5.2Secondary end point(s)
    - Occurrence of clinically relevant and non-relevant leg vein thromboses
    - Occurrence of any bleeding (BARC ≥ 1)
    - Auftreten klinisch relevanter und nicht relevanter Beinvenenthrombosen
    - Auftreten jeglicher Blutungen (BARC ≥ 1)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within two weeks after arrival of the return flight.
    Binnen zwei Wochen nach Ankunft bei Rückflug.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 trial2
    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 concerned2
    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
    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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 25198
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2500
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 Yes
    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 state27698
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 27698
    F.4.2.2In the whole clinical trial 27698
    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)
    Subjects included in the trial will receive further treatment and care after the end of the clinical trial (end of the follow-up period), if necessary, according to the clinical picture. No additional examinations will take place.
    Die in die Studie eingeschlossenen Probanden werden nach Beendigung der klinischen Prüfung (Ende des Nachbeobachtungszeitraums), falls erforderlich, entsprechend dem Krankheitsbild weiterbehandelt und betreut. Es finden keine zusätzlichen Untersuchungen statt.
    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 Decision2023-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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