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    Summary
    EudraCT Number:2012-000108-13
    Sponsor's Protocol Code Number:UKM10_0018
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-11-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2012-000108-13
    A.3Full title of the trial
    A phase II multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Proof of concept, multicenter trial with Rivaroxaban in the treatment of livedoid vasculopathy assessing the pain on a visual analog scale (VAS)
    A.3.2Name or abbreviated title of the trial where available
    Riliva
    A.4.1Sponsor's protocol code numberUKM10_0018
    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 SponsorUniversitätsklinikum Münster
    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 supportBayer Vital GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Münster
    B.5.2Functional name of contact pointKlinik für Hautkrankheiten
    B.5.3 Address:
    B.5.3.1Street AddressVon-Esmarch-Straße 58
    B.5.3.2Town/ cityMünster
    B.5.3.3Post code48149
    B.5.3.4CountryGermany
    B.5.6E-mailtobias.goerge@ukmuenster.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 Yes
    D.2.1.1.1Trade name Xarelto 10 mg
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameRivaroxaban
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNRIVAROXABAN
    D.3.9.1CAS number 366789-02-8
    D.3.9.4EV Substance CodeSUB29263
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Treatment of livedoid vasculopathy
    E.1.1.1Medical condition in easily understood language
    Treatment of disease which leads to vascular obliteration.
    Affected is the skin of feet and lower leg.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the trial is the statistical evaluation of the therapeutic effects of rivaroxaban in patients with livedoid vasculopathy.
    E.2.2Secondary objectives of the trial
    Secondary objectives of the trial are the evaluation of quality of life, patient safety and the consumption of rescue medication.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Secured livedo vasculopathy
    2) Age ≥ 18 years and ≤ 80 years
    3) 40 points on the pain VAS at least one day within the last 7 days before beginning therapy
    4) No participation in another intervention study within the last 30 days before beginning therapy
    5) Adequate communication skills in the German language
    6) Patient must be able to recognize the nature, significance and scope of the clinical trial and to align his will hereafter
    1. gesicherte Livedo-Vaskulopathie
    2. Alter 18 bis 80 Jahre
    3. 40 Punkte Schmerzhaftigkeit auf der VAS an mindestens einem Tag innerhalb der letzten 7 Tage vor Therapiebeginn
    4. Keine Teilnahme an einer anderen Interventionsstudie innerhalb der letzten 30 Tage vor Therapiebeginn
    5. Ausreichende Kommunikationsfähigkeit in der deutschen Sprache
    6. Patient muss in der Lage sein Wesen, Bedeutung und Tragweite der klinischen Prüfung zu erkennen und seinen Willen hiernach auszurichten
    E.4Principal exclusion criteria
    1) Known allergy to the study medication
    2) Known problems of galactose intolerance, deficit of lactase or glucose-galactose malabsorption
    3) Pregnancy
    4) In women: unsecured contraception (Requirement: Pearl Index <1)
    5) Lactation
    6) Known renal impairment (creatinine clearance <30ml/min)
    7) Known liver disease (Child-Pugh score B and C)
    8) Known ulcerative gastrointestinal disorders within the last 30 days prior to initiation of therapy or during
    9) Uncontrolled, severe arterial hypertension
    10) Artificial heart valves
    11) Acute pulmonary embolism
    12) Known bronchiectasis or pulmonary bleeding
    13) Known vascular retinopathy
    14) Intracranial or intracerebral haemorrhage within the last 30 days before beginning of therapy or during therapy
    15) Brain, spinal cord or eye surgery within the last 30 days before beginning of therapy or during therapy
    16) Spinal or epidural anaesthesia or puncture within the last 2 weeks before beginning of therapy or during therapy
    17) Application of systemic heparin within 1 day before beginning of therapy
    18) Intake of NSARs or thrombocyte aggregation inhibitors within 1 day before beginning of therapy or during therapy
    19) Intake of vitamin-K-antagonists (marcumar, warfarin) and/or thrombin inhibitor (dabigatran) within 7 days before beginning of therapy or during therapy
    20) Concomitant use of CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital or St. John’s Wort)
    21) Concomitant systemic treatment with
    azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole)
    22) Concomitant systemic treatment with HIV-protease inhibitors (e.g. ritonavir)
    23) Concomitant systemic treatment with dronedarone
    24) Presence of malignant neoplasms at high risk of bleeding
    25) Recent brain or spinal injury
    26) Known or suspected oesophageal varices
    27) Known arteriovenous malformations
    28) Known vascular aneurysms
    29) Known major intraspinal or intracerebral vascular abnormalities
    1. Bekannte Allergie gegen das Prüfpräparat
    2. Bekannte Galactose-Intoleranz, Lactase-Mangel oder Glucose- Galactose-Malabsorption
    3. Schwangerschaft
    4. Bei Frauen: nicht gesicherte Kontrazeption (Anforderung: Pearl Index < 1)
    5. Stillzeit
    6. Bekannte Nierenfunktionsstörungen (Kreatinin-Clearance <30ml/min)
    7. Bekannte Lebererkrankungen (Child-Pugh-Score B und C)
    8. Bekannte ulzerative Erkrankungen des Gastrointestinaltrakts innerhalb der letzten 30 Tage vor Therapiebeginn oder im Verlauf
    9. Nicht eingestellte, schwere arterielle Hypertonie (Stufe 3)
    10. Künstliche Herzklappen
    11. Akute Lungenembolie
    12. Bronchiektasie oder pulmonale Blutung in der Anamnese
    13. Bekannte vaskuläre Retinopathie
    14. Intrakranielle oder intrazerebrale Blutung innerhalb der letzten 30 Tage vor Therapiebeginn oder im Verlauf
    15. Operationen am Gehirn, Rückenmark oder Auge innerhalb der letzten 30 Tage vor Therapiebeginn oder im Verlauf
    16. Spinal/Epiduralanästhesie oder -punktion innerhalb von 2 Wochen vor Therapiebeginn oder im Verlauf
    17. Applikation von systemischem Heparin innerhalb von 1 Tag vor Therapiebeginn
    18. Einnahme von NSARs oder Thrombozytenaggregationshemmer innerhalb von 1 Tag vor Therapiebeginn oder im Verlauf
    19. Einnahme vom Vitamin-K-Antagonisten (Marcumar, Warfarin) und/oder Thrombinhemmer (Dabigatran) innerhalb von 7 Tagen vor Therapiebeginn oder im Verlauf
    20. Gleichzeitige Gabe von CYP3A4 Induktoren (z. B. Rifampicin, Phenytoin, Carbamazepin, Phenobarbital oder Johanniskraut)
    21. Gleichzeitig systemische Behandlung mit Azol-Antimykotika (wie Ketoconazol, Itraconazol, Voriconazol und Posaconazol)
    22. Gleichzeitig systemische Behandlung mit HIV-Proteaseinhibitoren (z. B. Ritonavir)
    23. Gleichzeitig systemische Behandlung mit Dronedaron
    24. Maligne Neoplasien mit hohem Blutungsrisiko
    25. Kürzlich aufgetretene Hirn- oder Rückenmarksverletzungen
    26. Bekannte oder vermutete Ösophagusvarizen
    27. Bekannte arteriovenöse Fehlbildungen
    28. Bekannte vaskuläre Aneurysmen
    29. Bekannte größere intraspinale oder intrazerebrale vaskuläre Anomalien
    E.5 End points
    E.5.1Primary end point(s)
    Assessment of local pain on the VAS; intraindividual difference of two values ​​on the VAS between baseline ("before") and after 12 weeks ("after")
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 12 weeks
    E.5.2Secondary end point(s)
    1) Assessment of local pain on the VAS; intraindividual difference of values ​​on VAS between baseline ("before") and after 4 weeks
    2) Assessment of local pain on the VAS; intraindividual difference of values ​​on VAS between baseline ("before") and after 8 weeks
    3) Assessment (DLQI); intraindividual difference of values ​​between baseline ("before") and after 4 weeks
    4) Assessment (DLQI); intraindividual difference of values ​​between baseline ("before") and after 8 weeks
    5) Assessment (DLQI); intraindividual difference of values ​​between baseline ("before") and after 12 weeks ("after")
    6) Consumption of rescue medication
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 4, 8 and 12 weeks
    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 No
    E.8.1.1Randomised No
    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 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 No
    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 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
    The entire study ends after all queries are answered from the data management through the study sites and the database is closed.
    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 months3
    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: 16
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    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 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 state20
    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 Decision2012-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-09-11
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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