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    Summary
    EudraCT Number:2014-005145-51
    Sponsor's Protocol Code Number:13-152
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-08-18
    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 number2014-005145-51
    A.3Full title of the trial
    A randomised controlled multicenter trial comparing ultrasound-accelerated catheter-directed thrombolysis, combined with standard anticoagulant therapy, with standard anticoagulant therapy alone, for acute primary iliofemoral deep vein thrombosis
    EINE RANDOMISIERTE KONTROLLIERT MULTIZENTRISCHE STUDIE ZUM VERGLEICH DER ULTRASCHALL-VERSTÄRKTEN KATHETER-GERICHTETEN THROMBOLYSE IN KOMBINATION MIT STANDARD-ANTIKOAGULANZTHERAPIE UND EINFACHER STANDARD-ANTIKOAGULANZTHERAPIE BEI AKUTER ILEOFEMURALER PRIMÄRER TIEFER VENENTHROMBOSE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised controlled multicenter trial comparing ultrasound-accelerated catheter-directed thrombolysis, combined with standard anticoagulant therapy, with standard anticoagulant therapy alone, for acute primary iliofemoral deep vein thrombosis
    EINE RANDOMISIERTE KONTROLLIERT MULTIZENTRISCHE STUDIE ZUM VERGLEICH DER ULTRASCHALL-VERSTÄRKTEN KATHETER-GERICHTETEN THROMBOLYSE IN KOMBINATION MIT STANDARD-ANTIKOAGULANZTHERAPIE UND EINFACHER STANDARD-ANTIKOAGULANZTHERAPIE BEI AKUTER ILEOFEMURALER PRIMÄRER TIEFER VENENTHROMBOSE
    A.3.2Name or abbreviated title of the trial where available
    CAVA
    A.4.1Sponsor's protocol code number13-152
    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 SponsorMaastricht University Medical Centre
    B.1.3.4CountryNetherlands
    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 supportClinical Trial Center Maastricht
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportmedac GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University Medical Centre
    B.5.2Functional name of contact pointMD, PhD, internal medicine & bioche
    B.5.3 Address:
    B.5.3.1Street AddressP. Debyelaan 25, P.O. Box 5800
    B.5.3.2Town/ cityMaastricht
    B.5.3.4CountryNetherlands
    B.5.6E-mailh.tencate@maastrichtuniversity.nl
    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 Urokinase HS medac
    D.2.1.1.2Name of the Marketing Authorisation holderMedac, Hamburg, Germany
    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 nameUrokinase
    D.3.2Product code Urokinase
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial 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
    Acute primary iliofemoral deep vein thrombosis
    E.1.1.1Medical condition in easily understood language
    Acute leg vein thrombosis
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    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 whether catheter directed thrombolytic therapy for the treatment of IFDVT can safely and effectively reduce post thrombotic morbidity after one year.
    E.2.2Secondary objectives of the trial
    The secondary objective is to study whether catheter directed thrombolytic intervention has a positive effect on the quality of life of patients with IFDVT and to assess late PTS.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients aged between 18-65 years
    Written informed consent prior to study participation
    First thrombus in the affected limb
    Objectively documented IFDVT on compression ultrasound.
    Acute stage IFDVT, complaints less than 14 days
    Life expectancy longer than 6 months
    E.4Principal exclusion criteria
    Previous thrombosis of the affected limb (secondary thrombosis)
    Surgery within 2 weeks
    Varicosities/venous insufficiency CEAP classification C3 or higher.
    History of GI bleeding within 3 months
    History of CVA/central nervous system disease within 12 months
    Severe hypertension (>180/100 mmHg)
    ALT > 3 times normal range
    eGFR < 30 ml/min
    Hypersensitivity to the active substance or to any of the excipients
    Dual antiplatelettherapy
    Dysfunction of thyroid gland
    Decreased blood coagulation (haemorrhagic diathesis, concomitant therapy with anticoagulants, spontaneous fibrinolysis) and severe thrombocytopenia
    Aneurysm and arteriovenous malformation
    Acute pancreatitis, pericarditis, bacterial endocarditis, sepsis
    Recent trauma including cardiopulmonary resuscitation, thoracic surgery or neurosurgery (e.g. within 2 months)
    Increased risk of bleeding or previous severe bleeding event
    known clinical hypersensitivity or prior reactions on contrast agents
    history of asthma or other allergic troubles
    Active malignancy
    life expectancy < 6 month
    Women, who are pregnant or without sufficient contraception or breastfeeding.
    Alcohol or drug abuse
    Employees of the investigator cooperation companies
    Expected non-compliance
    Patients unwilling or unable to give informed consent, patients with limited ability to comply with instructions for this study
    Participation on another clinical trial within the last 3 months
    Subjects who are committed to an institution and/or penitentiary by judicial or official order
    Immobility (Depending on wheelchair)
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of patients with PTS characterized by a Villalta-Prandoni score ≥ 5 on two consecutive occasions of at least 3 months apart, or presence of a venous ulcer one year following the acute thrombotic event. (Villalta-Prandoni: score 5-9 = mild PTS, score 10-14 = moderate PTS, score ≥ 15 or venous ulcer = severe PTS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 3, 6, 12, 24, 36, 48 after inclusion
    E.5.2Secondary end point(s)
    The Health Related Quality of Life (HRQOL) based on scorings on SF-36, EuroQOL-5D, VEINES-QOL/Sym and pain disability index (3, 6 and 12 months after the event)
    Late PTS during follow-up
    Recurrent venous thrombo-embolisms (VTE): DVT (measured by Compression ultra sonography (CUS)) or pulmonary embolism (PE) during follow-up
    Clot lysis, patency (measured by MRA-Vasovist during baseline visit and after 12 months, which shows the occlusion percentage of all visualized veins).
    Measurements of markers of coagulation (INR, fibrinogen, aPTT) and inflammation (CRP, leucocytes) at the baseline visit, during treatment visit and 12 months after the event.
    Safety outcome: Bleeding events during anticoagulant therapy.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Questionaires: baseline, month 3,6,12,24,36,48
    Late PTS during follow-up: month 3,6,12,24,36,48
    CUS/PE: Baseline
    Clot lysis, patency: baseline, after 12 months
    coagulation/inflamation markers: baseline, month 3,6,12,24,36,48
    Bleeding events: baseline, month 3,6,12,24,36,48
    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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    conservative regimen of anticoagulant therapy alone
    E.8.2.4Number of treatment arms in the trial2
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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
    last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months6
    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: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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)
    normal treatment of that condition
    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 Decision2015-09-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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