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    Summary
    EudraCT Number:2020-000749-15
    Sponsor's Protocol Code Number:NL73142.068.20
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-05-18
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-000749-15
    A.3Full title of the trial
    Resolution Enhancement by a Supplemental Open-Label Venoactive drug for Eight weeks in Deep Vein Thrombosis
    Verbetering van trombusresolutie met een aanvullend open-label venoactief medicijn voor acht weken in diep-veneuze trombose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Preventing lifelong changes and complaints of the leg after a clot has formed in the vein of the leg with an additional medincine
    Voorkomen van levenslange veranderingen en klachten van het been nadat zich een stolsel heeft gevormd in de beenader met een medicijn
    A.3.2Name or abbreviated title of the trial where available
    The RESOLVE-DVT study
    De RESOLVE-DVT studie
    A.4.1Sponsor's protocol code numberNL73142.068.20
    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 SponsorAcademisch ziekenhuis Maastricht
    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 supportZonMw
    B.4.2CountryNetherlands
    B.4.1Name of organisation providing supportThrombosis Foundation Netherlands (pending)
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University Medical Center
    B.5.2Functional name of contact pointClinical Trial Center Maastricht
    B.5.3 Address:
    B.5.3.1Street AddressOxfordlaan 70
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229 EV
    B.5.3.4CountryNetherlands
    B.5.6E-mailsecretariaat.ctcm@mumc.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 Venoruton
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxoSmithKline Consumer Healthcare B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameVenoruton
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Post-thrombotic syndrome
    Post-trombotisch syndroom
    E.1.1.1Medical condition in easily understood language
    Lifelong complaints and changes of the leg which can develop after a clot has formed in the vein
    Levenslange klachten en veranderingen aan het been die kunnen ontstaan nadat zich in de ader een stolsel heeft gevormd
    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
    What is the effect of additional HR treatment for 8 weeks in combination with regular therapy on RVO after an acute, proximal DVT of the lower extremity?
    Wat is het effect van behandeling met HR voor 8 weken in aanvulling op reguliere behandeling voor RVO na een acute, proximale DVT van de onderste extremiteit?
    E.2.2Secondary objectives of the trial
    What is the effect of additional HR treatment for 8 weeks in combination with regular therapy on PTS-associated circulating biomarkers after a first, acute, proximal DVT of the lower extremity?

    What is the effect of additional HR treatment for 8 weeks in combination with regular therapy on PTS-characterizing symptoms and clinical signs after a first, acute, proximal DVT of the lower extremity?

    What is the effect of additional HR treatment for 8 weeks in combination with regular therapy on quality of life after a first, acute, proximal DVT of the lower extremity?
    Wat is het effect van behandeling met HR voor 8 weken in aanvulling op reguliere behandeling voor PTS-geassocieerde circulerende biomarkers na een eerste, acute, proximale DVT van de onderste extremiteit?

    Wat is het effect van behandeling met HR voor 8 weken in aanvulling op reguliere behandeling voor PTS-karakteriserende symptomen en klinische tekens na een eerste, acute, proximale DVT van de onderste extremiteit?

    Wat is het effect van behandeling met HR voor 8 weken in aanvulling op reguliere behandeling voor kwaliteit van leven na een eerste, acute, proximale DVT van de onderste extremiteit?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Adult, defined as ≥ 18 years of age
     Objectively confirmed DVT by duplex echography
     Proximal DVT, defined as an iliofemoropopliteal venous thrombosis
     Acute DVT, defined as having symptoms for ≤ 7 days at presentation
     Willing and able to give written consent
     Volwassen, gedefinieerd als ≥ 18 jaar oud
     Objectief vastgestelde DVT middels duplex echografie
     Proximale DVT, gedefinieerd als een iliofemoropopliteale veneuze trombose
     Acute DVT, gedefinieerd als het hebben van klachten voor ≤ 7 dagen voor presentatie
     Bereid en in staat om schriftelijk informed consent te geven
    E.4Principal exclusion criteria
     Previous DVT
     Bilateral DVT, since the unaffected leg is needed as a reference for clinical signs
     Pre-existent chronic venous insufficiency (CEAP-criteria C ≥ 3), since this influences thrombus resolution
     Active malignancy, inflammatory disease (e.g. rheumatoid arthritis) and/or immunosuppressive therapy, since this will influence circulating inflammatory biomarkers
     Current pregnancy, since knowledge on the teratogenicity of the IMP is too limited
     Indication for therapeutic thrombolysis, since this influences thrombus resolution
     Contra-indication for DOAC, including reduced kidney function (eGFR < 30 ml/min/1,73 m2) and underweight (<50kg)
     Eerdere DVT
     Bilaterale DVT, aangezien een niet-aangedaan been nodig is als referentie voor klinische tekens
     Pre-existente chronische veneuze insufficiëntie (CEAP-criteria C ≥ 3), aangezien dit trombusresolutie beïnvloedt
     Actieve maligniteit, inflammatoire ziekte (e.g. rheumatoide artritis) en.of immunosuppressieve therapie, aangezien deze de circulerende biomarkers zullen beïnvloeden
     Zwangerschap, aanezien kennis over de teratogeniciteit van dit middel ontoereikend is
     Indicatie voor therapeutische trombolyse, aangezien dit trombusresolutie beinvloedt
     Contra-indicatie voor directe orale anticoagulatie (DOAC), inclusief verminderde nierfunctie (eGFR < 30 ml/min/1,73 m2) en ondergewicht (<50kg)
    E.5 End points
    E.5.1Primary end point(s)
    Presence of RVO in proximal venous segments determined by echography
    Aanwezigheid van RVO in proximale veneuze segmenten, bepaald middels echografie
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 12 weeks after DVT.
    op 12 weken na DVT.
    E.5.2Secondary end point(s)
    - Levels of circulating makers (e.g. hs-CRP, IL-6, IL-8, IL-10, TNF-α, ICAM-1, VCAM-1, P-selectin, FVIII, MMP-1, MMP-8)

    - Scores on PTS-characterizing clinical signs of the affected leg (circumferences, pitting-edema, hyperpigmentation, venous ectasia, redness, skin induration, pain during calf compression, venous ulcers)

    - Scores on PTS-characterizing symptoms of the affected leg (pain, cramps, heaviness, paresthesia, pruritus)

    - Scores on quality of life
    - Hoogte van circulerende biomarkers (bv. hs-CRP, IL-6, IL-8, IL-10, TNF-α, ICAM-1, VCAM-1, P-selectin, FVIII, MMP-1, MMP-8)

    - Scores op PTS-karakteriserende klinische tekens van het aangedane been (omtrekken, pitting-oedeem, hyperpigmentatie, veneuze ectasieen, roodheid, huidinduratie, pijn tijdens kuitcompressie, veneuze ulceratie)

    - Scores op PTS-karakteriserende symptomen van het aangedane been (pijn, krampen, zwaar gevoel, paresthesieën, pruritus)

    - Scores op kwaliteit van leven
    E.5.2.1Timepoint(s) of evaluation of this end point
    - at baseline, 1 week, 4 weeks, 8 weeks and 12 weeks after DVT.
    - at baseline, 1 week, 4 weeks, 8 weeks and 12 weeks after DVT.
    - at baseline, 4 weeks and 12 weeks after DVT.
    - at baseline, 4 weeks and 12 weeks.
    - op baseline, 1 week, 4 weken, 8 weken en 12 weken na DVT.
    - op baseline, 1 week, 4 weken, 8 weken en 12 weken na DVT.
    - op baseline, 4 weken en 12 weken after DVT.
    - op baseline, 4 weken en 12 weken.
    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 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) 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
    Controlegriep krijgt enkel reguliere behandeling zonder het onderzoeksmiddel
    Control group only gets regular treatment without investigational medicinal product
    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 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 end of the trial will be when the last (44th) patient has finished follow-up by having his last (5th) outpatient clinic at 12 weeks after DVT.
    Het einde van de trial is wanneer de laatste (44ste) patient de follow-up voltooid door zijn laatste (5de) poliklinische visite op 12 weken na DVT.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 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 state44
    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
    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 Decision2020-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-08-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-28
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