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    Summary
    EudraCT Number:2022-000240-30
    Sponsor's Protocol Code Number:80308
    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:2022-04-08
    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 number2022-000240-30
    A.3Full title of the trial
    The chemopreventive effect of Lithium on adenoma development in patients with familial adenomatous polyposis (FAP); a pilot study
    Het preventieve effect van Lithium op adenoomvorming in patienten met familiaal adenomateus polyposis (FAP) syndroom: een pilot studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of Lithium on the inhibition of the formation of polyps in patients with familial adenomatous polyposis
    Het effect van het onderzoeksgeneesmiddel (Lithium) op de remming van poliepvorming in patiënten met Familiale Adenomateuze Polyposis.
    A.3.2Name or abbreviated title of the trial where available
    Lithium in FAP
    Lithium in FAP
    A.4.1Sponsor's protocol code number80308
    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 SponsorCenter for Experimental and Molecular Medicine, G2 (AMC)
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Lithiumcarbonate
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Nederland BV
    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 nameLithiumcarbonate
    D.3.2Product code 55991
    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
    Familial adenomatous polyposis
    Familiaire adenomateuze polyposis
    E.1.1.1Medical condition in easily understood language
    Familial adenomatous polyposis
    Familiaire adenomateuze polyposis
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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 aim of this study is to investigate the effect of low-dose Lithium on stem cell dynamics, the number and size of polyps and, to assess safety outcomes of this drug in FAP patients.
    Het doel van deze studie is om het effect van lage dosering Lithium te onderzoeken op stamceldynamiek, het aantal en grootte van de poliepen en het beoordelen van de veiligheid van deze behandeling in FAP patienten.
    E.2.2Secondary objectives of the trial
    /
    /
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female between the age of 18 and 35 years;
    - Confirmed APC germline mutation;
    - Positive family history of a classical FAP phenotype (>100 colorectal adenomas);
    - Intact colon, with a minimum of 50 polyps;
    - Participant is willing and able to give informed consent for participation
    - man of vrouw tussen de leeftijd van 18 en 35 jaar
    - bevestigde kiembaanmuatie in het APC gen
    - Positieve familieanamnese voor klassieke FAP fenotype (>100 Colorectale adenomen)
    - volledig colon, met een minimun van 50 poliepen
    - patient is bevoegd en wilsbekwaan voro het geven van informed consent
    E.4Principal exclusion criteria
    - Participation in any other clinical intervention study; observational trials accepted;
    - Lithium use prior to participation of the study;
    - Pregnancy, breast-feeding or no use of anticonception;
    - No normal intestinal mucosa left for normal tissue biopsy;
    - Indication for colectomy within 2 years;
    - Known renal impairment, defined as GFR < 60 ml/min;
    - Known severe cardiac disorder;
    - Known severe brain injury;
    - Hypothyroidism;
    - Hyponatremia, defined as Na < 130mmol/L;
    - Positive family history of Brugada syndrome
    - Co-medication known for interacting with Lithium (as defined in the protocol).
    - Regular NSAID use (defined as more than twice a week for 4 consecutive weeks) within 3 months prior to baseline;
    - Use of immunosuppressive or anti-inflammatory drugs within 3 months prior to baseline;
    - Use of any other FAP directed drug therapy within 3 months prior to baseline (use of any alternative supplements e.g. turmeric or fish-oil must be noted in questionnaire).
    - deelname in een andere klinische interventiestudie; observationele trials worden geaccepteerd
    - het gebruik van lithium voorafgaand aan de studie
    - zwangerschap, het geven van borstvoeding of het niet gebruiken van anticonceptie
    - geen normaal intestinaal mucosa voor het nemen van normaal weefsel biopt
    - patienten die een indicatie hebben voro een colectomie binnen de komende 2 jaar
    - bekende verminderde nierfunctie, gedefinieerd als een GFR onder de 60 ml/min
    - bekende ernstige cardiale stoornis
    - bekende ernstige hersenschade
    - hypothyreoidie
    - hyponatriemie, gedefinieerd als een natrium onder de 130mmol/L
    - positieve familieanamnese voor het brugada syndroom
    - het gebruik van comedicatie waarvan bekend is dat deze een interactie aangaat met Lithium
    - regulier NSAID gebruik (gedefinieerd als meer dan 2 keer per week voor 4 aansluitende weken) binnen de afgelopen 3 maanden voor baseline.
    - het gebruik van immunosuppresiva of anti-inflammatoire medicijnen in de afgelopen 3 maanden voor deelname aan de studie
    - he gebruik van elke andere FAP-medicatie in de afgelopen 3 maanden voor deelname aan de studie (het gebruik van alternatieve supplementen zoals kurkuma of visolie moet genoemd wordne in de vragenlijst)
    E.5 End points
    E.5.1Primary end point(s)
    - Clone sizes will be quantified as proportions of the crypt circumference positive for NOTUM (in parts of eight, 1:8 to 8:8). When a whole crypt is positive for NOTUM (8:8), this crypt is fixed (crypt fixation).
    - De grootte van de clone wordt gekwantificeerd als het percentage van de cryptomvang dat positief is voor NOTUM (in parten van acht, 1:8 tot 8:8). Wanneer een hele crypte positief is voor NOTUM (8 parten, 8:8), is deze crypte gefixeerd (crypt fixatie).
    E.5.1.1Timepoint(s) of evaluation of this end point
    every 6 months (t=0m, t=6m, t=12m, t=18m)
    iedere 6 maanden (t=0m, t=6m, t=12m, t=18m)
    E.5.2Secondary end point(s)
    - Difference in number and size of polyps between baseline and end of study
    - Patient reported side effects of Lithium using a Lithium side effect questionnaire (see appendix 2 of the protocol)
    - Safety outcomes by analysing reported adverse events, physical examination and laboratory findings.
    - Verschil in aantal en grootte van poliepen tussen baseline an einde van de studie.
    - Door de patient gerapporteerde bijwerkingen van Lithium met behulp van een Lithium bijwerkingen vragenlijst (als te zien in bijlage2 van protocol).
    - Veiligheid van de behandeling (adverse events, lichamelijk onderzoek en labafwijkingen).
    E.5.2.1Timepoint(s) of evaluation of this end point
    every 6 months (t=0m, t=6m, t=12m, t=18m)
    iedere 6 maanden (t=0m, t=6m, t=12m, t=18m)
    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) 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 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
    LVLS
    Laatse bezoek van laatste deelnemer
    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: 12
    F.1.3Elderly (>=65 years) No
    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 state12
    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 Decision2022-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-05
    P. End of Trial
    P.End of Trial StatusOngoing
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