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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2014-002970-36
    Sponsor's Protocol Code Number:54508
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-01-13
    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 number2014-002970-36
    A.3Full title of the trial
    Human intestinal ischemia and reperfusion
    Humane darm ischemie en reperfusie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Oxygen deficiency of the human bowel
    Zuurstofgebrek van de darm in de mens
    A.3.2Name or abbreviated title of the trial where available
    Human intestinal IR
    Humane darm IR
    A.4.1Sponsor's protocol code number54508
    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 Center
    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 supportMLDS
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMaastricht University
    B.5.2Functional name of contact pointClaire Leenarts
    B.5.3 Address:
    B.5.3.1Street AddressUniversiteitssingel 50
    B.5.3.2Town/ cityMaastricht
    B.5.3.3Post code6229 ER
    B.5.3.4CountryNetherlands
    B.5.6E-mailclaireleenarts@hotmail.com
    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 Cyklokapron
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer bv
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTranexmic acid
    D.3.2Product code TA
    D.3.4Pharmaceutical form Gastroenteral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    Intestinal 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.IMP: 2
    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 Doxycycline
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer bv
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameDoxycycline
    D.3.2Product code doxy
    D.3.4Pharmaceutical form Gastroenteral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    Intestinal 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection
    D.8.4Route of administration of the placeboIntestinal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The participants enrolled in this study will all undergo major upper abdominal surgery (i.e. mostly Pylorus Preserving Pancreatico Duodenectomy or whipple procedure) mostly for pancreatic cancer, papillary carcinoma or pancreatitis.
    However, the indication for which the IMP is administered is intestinal ischemia and reperfusion.
    De deelnemers aan de studie ondergaan allen grote abdominale chirurgie (veelal Pylorus Preserving Pancreatico Duodenectomie of whipple procedure) meestal in het kader van pancreas of papilcarcinoom dan wel pancreatitis.
    Echter, de indicatie waarvoor het IMP wordt toegediend is darm ischemie en reperfusie.
    E.1.1.1Medical condition in easily understood language
    Oxygen deficiency of the human bowel
    Zuurstofgebrek van de darm oftewel het darminfarct
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    This study aims at (further) revealing the pathophysiology of intestinal IR in man, with a specific interest for the role of proteases and protease-activated receptor-2 (PAR-2), cellular and inflammatory changes, barrier function and intestinal permeability, microscopic mucosal changes and gene expression patterns. An important element will be the determination of the effects of protease- and MMP inhibitors. By these means we hope to identify preventive and therapeutic strategies for patients with intestinal IR.
    Ophelderen van de pathofysiologie van darm ischemie in de mens, met een bijzondere interesse voor de de rol van proteases en protease-activated receptor-2 (PAR-2), cellulaire en inflammatoire veranderingen, barriere functie en darm permeabiliteit, microscopische mucosale veranderingen en gen expressie patronen. Een belangrijk element zal het in kaart brengen van de effecten van protease- en MMP inhibitoren zijn. We hopen nieuwe preventieve en therapeutische strategieen te ontwikkelen voor patienten met darm IR.
    E.2.2Secondary objectives of the trial
    Not applicable
    niet van toepassing
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult patients (18 years of age and older) undergoing major upper abdominal surgery
    o Whipple-procedure or pylorus preserving pancreatico duodenectomy (PPPD)
    o Ileo-Jejunal bypass surgery
    o Roux-en-Y gastric bypass
    o Total gastrectomy
    o Hepatico jejunostomy
    o Pancreaticojejunostomy (Frey’s procedure)

    Patients who have given an informed consent
    Volwassen patient (18 jaar of ouder) die grote bovenbuikschirurgie ondergaan
    o Whipple-procedure of pylorus preserving pancreatico duodenectomie (PPPD)
    o Ileo-Jejunal bypass chirurgie
    o Roux-en-Y gastric bypass
    o Totale gastrectomie
    o Hepatico jejunostomie
    o Pancreaticojejunostomie (Frey’s procedure)

    Patienten die informed consent hebben gegeven
    E.4Principal exclusion criteria
    <18 years of age or older but no proper understanding of the research proposal
    Inflammatory bowel disease
    Celiac disease
    Acute major abdominal procedures
    Patients who have refused informed consent

    For the population who will receive tranexamic acid additional exclusion criteria have been formulated:

    Active or history of thrombo-embolic disorders such as deep venous thrombosis, pulmonary embolism or cerebral embolism
    History of blood coagulation disorder (hypercoagulation state)
    Subarachnoid hemorrhage
    Disseminated intravascular coagulation (DIS)
    Severe renal insufficiency: i.e. serum kreatinine >150 µmol/L
    History of convulsions
    Pregnancy
    Known hypersensitivity of allergy for tranexamic acid
    Simultaneous use of thrombolytics (e.g. alteplase, streptokinase)
    Simultaneous use of hormonal anticonceptives or other substances that induce hemostasis.

    For the population who will receive doxycycline additional exclusion criteria have been formulated:

    Known hypersensitivity of allergy for tetracyclines.
    Severe liver function disorder i.e. ASAT or ALAT or AF or γ-GT >150 U/L whether or not combined with severe renal insufficiency: i.e. serum kreatinine >150 µmol/L.
    Severe renal insufficiency: i.e. serum kreatinine >150 µmol/L.
    Porphyria
    Myasthenia gravis
    Simultaneous usage (or just before or after administration of doxycycline) of oral retinoids or substances containing metalions (such as antagel or ironpreparations)
    Simultaneous use of methoxyflurane (anesthetic) or oral contraceptives
    Bodyweight beneath 50 kg
    History of blood coagulation disorder (inert hypocoagulation state)
    Pregnancy or lactating
    <18 jaar of ouder maar geen adequaat inzicht in het onderzoek
    IBD
    Coeliakie
    Acute abdominale procedures
    Patienten die geen informed consent hebben gegeven

    Voor de tranexaminezuur groep ook de volgende criteria:

    voorgeschiedenis van thrombo-embolische aandoeningen bijv DVT, longembolie, hersenembolie
    voorgeschidenis van stollingsstoornis (hypercoagulatie)
    Subarachnoidale bloeding
    Disseminated intravascular coagulation (DIS)
    Ernstige nierinsifficientie: i.e. serum kreatinine >150 µmol/L
    voorgeschiedenis met convulsies
    zwangerschap
    gekende overgevoeligheid of allergie voor tranexaminezuur
    gelijktijdig gebruik van trombolytica (bijv. alteplase, streptokinase) of hormonale anticonceptie of andere stoffen die hemostase induceren.

    Aanvullende criteria voor doxycycline:

    gekende overgevoeligheid of allergie voor tetracyclines.
    Ernstige lever functie stoornis i.e. ASAT or ALAT or AF or γ-GT >150 U/L al dan niet gecombineerd met ernstige nierinsufficientie: i.e. serum kreatinine >150 µmol/L.
    ernstige nier insufficientie: i.e. serum kreatinine >150 µmol/L.
    Porfyrie
    Myasthenia gravis
    Gelijktijdig gebruik van orale retinoiden of stoffen met metaalionen als antagel of ijzerpreparaten
    Gelijktijdig gebruik van methoxyfluraan of orale anticonceptie
    lichaamsgewicht onder 50 kg
    voorgeschiedenis met stollingsstoornis (hypocoagulatie)
    zwangerschap of lactatie
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is inflammation (neutrophil influx, complement activation, interleukins, TNF-α, COX 1-2) and protease activity in tissue as well as in blood plasma.
    inflammatie (neutrofiel influx, complement activatie, interleukines, TNF-α, COX 1-2) en protease activiteit in weefsel en plasma.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after ischemia, after short respectively prolonged reperfusion and in control samples.
    na ischemie, na korte respectievelijk lange reperfusie en in controle samples
    E.5.2Secondary end point(s)
    The secondary study parameter is intestinal cell damage, which will be evaluated by assessment of plasma levels of I-FABP, ILBP as well as tissue stainings for morphology, tight junctions, apoptosis, goblet cells, mucines, cell proliferation, I-FABP, L-FABP and SM22.
    darmschade, welke geevalueerd zal worden dmv plasma levels van I-FABP, ILBP alsmede weefsekleuringen voor morfologie, tight junctions, apoptose, goblet cellen, mucines, cel proliferatie, I-FABP, L-FABP en SM22.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after ischemia, after short respectively prolonged reperfusion and in control samples.
    na ischemie, na korte respectievelijk lange reperfusie en in controle samples
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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: 21
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 21
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state42
    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
    geen
    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 Decision2016-01-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-06
    P. End of Trial
    P.End of Trial StatusOngoing
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