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    Summary
    EudraCT Number:2018-001845-15
    Sponsor's Protocol Code Number:TINCRBEL_study
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2018-06-27
    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 number2018-001845-15
    A.3Full title of the trial
    EvaluaTion of Clinical and laboratory outcomes of Rivaroxaban in short Bowel syndrome patients dEpending on Long term parenteral nutrition: a prospective cohort study (TINCRBEL study)
    Evaluatie van klinische en laboratorische uitkomstmaten van Rivaroxaban inShort Bowel Syndrome patiënten, afhankelijk van lange termijn parenterale voeding: een prospectief cohort studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of how well rivaroxaban is absorbed in patients with short bowel syndrom, based on laboratory markers and clinical outcomes such as thrombosis and bleeding.
    A.3.2Name or abbreviated title of the trial where available
    TINCRBEL study
    A.4.1Sponsor's protocol code numberTINCRBEL_study
    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 SponsorAcademic medical centre, department of internal medicine
    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 supportAcademic Medical centre, department of internal medicine
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical centre, department of internal medicine
    B.5.2Functional name of contact pointMichiel Coppens
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105az
    B.5.3.4CountryNetherlands
    B.5.6E-mailm.coppens@amc.uva.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 Xarelto
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    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 nameXarelto
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    Oropharyngeal 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
    Chronic intestinal failuyre (IF) is caused by large surgical bowel resection, severe motility, or absorption diseorders. These patientds require partial or total parenteral nutrition (PN and TPN, respectively) and are thereby critically dependent on maintaining venous acces withj central venous catheter (CVC). CVC-related thrombosis is a frequent and serious complication that leads to catheter failure and is associated with CVC-infections and sepsis.
    E.1.1.1Medical condition in easily understood language
    Parenteral nutrition via central venous catheter is essential in patients unable to receive nutrition by oral intake or enteral tube feeding. Catheter-thrombosis is an important complication.
    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
    The main aim of this study is to assess the clinical outcomes of this patient population treated with long-term parenteral nutrition and taking rivaroxaban and to relate these clinical outcomes to the laboratory assessments. The primary outcomes are the clinical outcomes after at least one year and the (variability in the) laboratory concentrations.
    E.2.2Secondary objectives of the trial
    Secondary outcomes consist assessment of the quality of life in this patient population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Diagnosis of short bowel syndrome (<170 cm after Treitz ligamentum) or intestinal malabsorption, diagnosed by an endocrinologist in the AMC

    - Current use of TPN

    - Age 18 years or over

    - Indication for anticoagulant therapy before the start of TPN (DOAC, vitamin K antagonist, heparin) such as stroke prevention in patients with atrial fibrillation, prevention of venous thromboembolic events
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study

    - Symptomatic thrombosis at inclusion

    - Major bleeding defined according to the International Society on Thrombosis and Haemostasis(11) in the 6 months prior to start participation

    - Contraindication for direct oral anticoagulant

    o Chronic treatment with NSAID/Cytochrome P450/PgP dependent co-

    medication

    o Severe renal (eGFR<15) or hepatic impairment (Child Pugh score B or C) o Pregnancy or inadequate use of contraception

    - Gastrectomy or short bowel syndrome < 30 cm after Treitz ligamentum

    - Medical or psychological condition that would not permit completion of the study or signing of informed consent, including life expectancy less than six months, or unwillingness to sign informed consent;

    - Non-compliance or inability to adhere to treatment or to the follow-up visits.
    E.5 End points
    E.5.1Primary end point(s)
    i. Main study parameter/endpoint

    Clinical outcomes after one year, related to the laboratory levels per subject:

    * Efficacy: venous thromboembolism, cerebrovascular stroke

    * Safety: (major) bleeding cfr. ISTH criteria, mortality

    ii. Secondary study parameters/endpoints

    * Inter- and intraindividual variability of rivaroxaban absorption

    Laboratory outcomes:

    * Correlation between anti Xa levels and rivaroxaban plasma concetrations as assessed by LC-MS/MS

    Quality of life assessment

    * SF-36 questionnaire


    iii. Other study parameters

    Baseline characteristics will be collected;

    * Age

    * Sex




    Version 1.1 16-03-2018 14 of 21

    NL63863.018.18 Rivaroxaban in patients with Short Bowel Syndrome




    * Underlying disease + severity score for SBS

    * Risk factors for VTE or Cerebral stroke

    * Co-morbidities

    * Co-medication (relevant)

    * Type and duration of anticoagulant treatment before switch to Rivaroxaban

    * Estimated length of remaining bowel after surgical intervention

    * Size, method of insertion catheter, thickness of lumen

    * Duration, concentration and composition of nutrition

    * Stoma production

    * Diary for keeping record of stool
    E.5.1.1Timepoint(s) of evaluation of this end point
    - every three months after inclusion in the study, minimum one year, maximum two years in total.
    E.5.2Secondary end point(s)
    1) Laboratory outcomes:

    * Inter- and intraindividual variability of rivaroxaban absorption

    * Correlation between anti Xa levels and rivaroxaban plasma concetrations as assessed by LC-MS/MS

    2) Quality of life assessment

    * SF-36 questionnaire
    E.5.2.1Timepoint(s) of evaluation of this end point
    Laboratory outcomes:

    - baseline = day of inclusion +/- 2 weeks: T=0, T=1 hour following first dose, T=2 hours following first dose, T=3, T=4, T=5, T=6
    - 3 months after inclusion: T=0, T=1 hour following first dose, T=2 hours following first dose, T=3, T=4, T=5, T=6
    - 6 months after inclusion: T=0, T=1 hour following first dose, T=2 hours following first dose, T=3, T=4, T=5, T=6


    Quality of life assessment:

    - baseline
    - 6 months after inclusion
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Prospective cohort drug study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 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
    LVLS
    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: 20
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2018-06-27. Yes
    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 state30
    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 Decision2018-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-18
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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