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    Summary
    EudraCT Number:2020-004604-33
    Sponsor's Protocol Code Number:TR-004
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2021-03-12
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-004604-33
    A.3Full title of the trial
    Open label, Multicenter, Prospective Study to Characterize the Pharmacokinetics and Pharmacodynamics of Cufence (Trientine Dihydrochloride) and to Investigate the Efficacy and Safety in Wilson’s Disease Patients
    Essai prospectif multicentrique en ouvert pour caractériser la pharmacocinétique et la pharmacodynamique de Cufence (dichlorhydrate de trientine) et d’en étudier l’efficacité et l’innocuité chez les patients atteints de la maladie de Wilson
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicentre, open-label study to investigate the effects Cufence has, the effects the body has on Cufence and the continued safety and efficacy on patients with Wilson Disease
    Essai prospectif en ouvert pour étudier les effets de Cufence, les effets de l'organisme sur Cufence, et l'innocuité et l'efficacité chez les patients atteints de la maladie de Wilson
    A.3.2Name or abbreviated title of the trial where available
    TR-004 UNITED Study
    A.4.1Sponsor's protocol code numberTR-004
    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 SponsorUnivar Solutions, B.V.
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUnivar Solutions, B.V
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationQPS Austria
    B.5.2Functional name of contact pointBarbara Derler
    B.5.3 Address:
    B.5.3.1Street AddressParkring 12
    B.5.3.2Town/ cityGrambach
    B.5.3.3Post code8074
    B.5.3.4CountryAustria
    B.5.4Telephone number0043316258111611
    B.5.5Fax number0043316258111300
    B.5.6E-mailbarbara.derler@qps.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 Cufence (trientine dihydrochloride)
    D.2.1.1.2Name of the Marketing Authorisation holderUnivar Solutions, B.V.
    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 nameCufence (trientine dihydrochloride)
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTriethylenetetramine dihydrochloride
    D.3.9.1CAS number 38260-01-4
    D.3.9.2Current sponsor codeTR-004
    D.3.9.3Other descriptive nameCufence
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    Wilson Disease
    Maladie de Wilson (MW)
    E.1.1.1Medical condition in easily understood language
    Wilson's disease is a rare inherited disorder that causes copper to accumulate in the liver, brain and other vital organs. If left untreated this can lead to significant damage and even death.
    MW est une maladie héréditaire rare (= accumulation de cuivre dans le foie, le cerveau et d'autres organes vitaux). Si non traitée, l'accumulation peut entraîner des dommages importants et/ou la mort.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.1
    E.1.2Level PT
    E.1.2Classification code 10019819
    E.1.2Term Hepato-lenticular degeneration
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the Cufence dose – exposure – copper markers (24-h urinary copper excretion (UCE), total serum copper, ceruloplasmin bound copper, non-ceruloplasmin bound copper (NCC)) relationships through population pharmacokineticpharmacodynamic (PKPD) modelling in Wilson’s disease (WD) patients and to evaluate the influence of patient characteristics on relevant model parameters, such as apparent clearance, apparent volume of distribution and drug potency.
    Caractériser les relations dose de Cufence – exposition – marqueurs du cuivre (excrétion urinaire de cuivre (UCE) sur 24 h, cuivre sérique total (Cu), cuivre lié à la céruloplasmine, cuivre non lié à la céruloplasmine (NCC)) par modélisation pharmacocinétique/ pharmacodynamique (PKPD) de population chez les patients atteints de la maladie de Wilson et évaluer l’influence des caractéristiques du patient sur les paramètres pertinents du modèle, tels que la clairance apparente, le volume apparent de distribution et l’efficacité du médicament.
    E.2.2Secondary objectives of the trial
    • To investigate the contribution of trientine, N(1)-acetyltriethylenetetramine (MAT) and
    N(1),N(10)-diacetyltriethylenetetramine (DAT) to the exposure and copper markers (exposure-response) in patients with Wilson’s disease.
    • To investigate the relationship between Cufence exposure (systemic trientine, MAT and DAT) and clinical efficacy measures (changes in neurological disease, changes in psychiatric symptoms and changes in hepatic disease) in patients with Wilson’s disease.
    • To investigate the relationships between copper markers (24-h UCE, total serum Cu, ceruloplasmin bound copper, NCC and clinical efficacy measures (changes in neurological disease, changes in psychiatric symptoms and changes in hepatic disease) in patients with
    Wilson’s disease.
    • To investigate the safety and tolerability of Cufence in patients with Wilson’s disease.
    •Étudier la contribution de la trientine, de la N(1)-acétyltriéthylènetétramine (MAT) et de la N(1), N(10)-diacétyltriéthylènetétramine (DAT) à l’exposition et aux marqueurs du cuivre* (exposition-effet) chez les patients atteints de la maladie de Wilson.
    •Étudier la relation entre l’exposition à Cufence (trientine, MAT et DAT systémiques) et les mesures d’efficacité clinique (modifications des troubles neurologiques, des symptômes psychiatriques et de l’hépatopathie) chez les patients atteints de la maladie de Wilson.
    •Étudier les relations entre les marqueurs du cuivre (UCE sur 24 h, Cu sérique total, cuivre lié à la céruloplasmine, NCC) et les mesures d’efficacité clinique (modifications des troubles neurologiques, des symptômes psychiatriques et de l’hépatopathie) chez les patients atteints de la maladie de Wilson.
    •Étudier l’innocuité et la tolérabilité de Cufence chez les patients atteints de la maladie de Wilson.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient (or a representative) must provide written, informed consent before the start of any study procedures.
    2. Male and female patient aged ≥ 5 years at time of consent.
    3. Diagnosis of WD previously determined by the physician based on a Leipzig score ≥ 4.
    4. Patient (≥ 18 years) has previously been treated with D-penicillamine for WD.
    5. Patient (< 18 years) has previously been treated with D-penicillamine or zinc for WD.
    6. For female patients of childbearing potential, a negative pregnancy test at the Screening visit and the Baseline visit is required. In addition, a highly effective method (failure
    rate <1%) of birth control must be used during the study which includes (but is not limited to) the following:
    - vasectomized partner (at least 6 months prior to dosing);
    - oral, patch, or injected contraceptives, or vaginal hormonal device (i.e. NuvaRing®), in use for at least 3 consecutive months prior to study dosing and throughout the study duration;
    - implanted or intrauterine contraceptives in use for at least 6 consecutive months prior to study dosing and throughout the study duration;
    - abstinence (must agree to use a highly effective method if they become sexually active during the study).
    7. Patient is considered to be able to complete study requirements and attend the study visits, in the opinion of the investigator.
    1.Le patient (ou un représentant) doit fournir un consentement écrit et éclairé avant le début de toute procédure de l’essai.
    2.Le patient, homme ou femme, doit être âgé de 5 ans ou plus au moment du consentement.
    3.Diagnostic de MW établi au préalable par un médecin sur la base d’un score de Leipzig ≥ 4.
    4.Le patient (≥ 18 ans) a déjà été traité pour la MW avec de la D-pénicillamine.
    5.Le patient (< 18 ans) a déjà été traité pour la MW avec de la D-pénicillamine ou du zinc.
    6.Pour les femmes en âge de procréer, un test de grossesse urinaire négatif est exigé lors des visites de sélection et d’inclusion. En outre, une méthode de contraception très efficace (taux d’échec < 1%) doit être utilisée pendant l’étude. Ces méthodes non exhaustives sont les suivantes :
    – partenaire ayant subi une vasectomie (au moins 6 mois avant l’étude) ;
    – contraceptif oraux, patchs ou injections, ou dispositif hormonal vaginal (i.e. NuvaRing®), utilisés pendant au moins 3 mois consécutifs avant l’étude et pendant toute la durée de l’étude ;
    – les contraceptifs implantés ou intra-utérins, utilisés pendant au moins 6 mois consécutifs avant l’étude et pendant toute la durée de l’étude ;
    – l’abstinence (devra utiliser un contraceptif très efficace si elle devient sexuellement active durant l’étude.
    7.L’investigateur estime que le patient est capable de répondre aux exigences de l’essai et d’assister aux visites d’essai.
    E.4Principal exclusion criteria
    1. Patient has evidence of uncontrolled liver disease, including but not limited to:
    a. New Wilson index (Dhawan Index) > 10
    b. Alanine aminotransferase (ALT) > 5x upper limit of normal (ULN)
    c. Aspartate aminotransferase (AST) > 5x ULN
    d. MELD score > 13 (only applicable for patients that are ≥ 12 years of age)
    e. Acute liver failure
    f. Hepatic malignancy
    2. Uncontrolled neurological disease according to the judgement of the physician.
    3. Patient has severe anaemia defined as hemoglobin of < 9 g/dL.
    4. Patient has a known intolerance, allergy or sensitivity to trientine dihydrochloride, including any component of the study medication.
    5. Female patient is pregnant or lactating.
    6. Adult patients who lack the capacity to consent.
    1.Le patient présente des signes d’hépatopathie non contrôlée, y compris, mais pas exclusivement :
    a. Un nouvel index de Wilson (index de Dhawan) > 10
    b. Alanine aminotransférase (ALAT) > 5x la limite supérieure de la normale (LSN)
    c. Aspartate aminotransférase (ASAT) > 5x LSN
    d. Score MELD (Model for End-Stage Liver Disease) > 13 (applicable uniquement aux patients âgés de 12 ans ou plus)
    e. Insuffisante hépatique aiguë
    f. Cancer du foie
    2. Troubles neurologiques non contrôlés selon le jugement du médecin.
    3. Le patient souffre d’une anémie sévère définie comme une hémoglobine < 9 g/dL.
    4. Le patient présente une intolérance, une allergie ou une sensibilité connue au dichlorhydrate de trientine, y compris tout composant du médicament à l’étude.
    5. Femme enceinte ou allaitante.
    6. Les patients adultes qui sont dans l’incapacité de comprendre l’information donnée et de signer le consentement éclairé.
    E.5 End points
    E.5.1Primary end point(s)
    • Concentration of trientine in plasma
    • Trientine clearance (CL/F) and volume(s) of distribution (V/F)
    • 24-h UCE (copper marker)
    • NCC* (copper marker)
    • Serum copper (copper marker)
    • Serum ceruloplasmin (copper marker)
    • Patient characteristics for covariates
    •Concentration plasmatique de trientine
    •Clairance (CL/F) et volume(s) de distribution (V/F) de la trientine
    •UCE sur 24 h (marqueur du cuivre)
    •NCC* (marqueur du cuivre)
    •Cuivre sérique (marqueur du cuivre)
    •Céruloplasmine sérique (marqueur du cuivre)
    •Caractéristiques des patients comme covariables
    E.5.1.1Timepoint(s) of evaluation of this end point
    • Concentration of trientine in plasma at Visit 2- Visit 10
    • Trientine clearance (CL/F) and volume(s) of distribution (V/F) at Visit 2- Visit 10 except Visit 5
    • 24-h UCE (copper marker)at Visit 2- Visit 10 except Visit 5
    • NCC* (copper marker) at Visit 2- Visit 10 except Visit 5
    Serum copper (copper marker)- Visit 2- Visit 10 except Visit 5
    •Concentration plasmatique de trientine de la visite 2 à la visite 10
    •Clairance (CL/F) et volume(s) de distribution (V/F) de la trientine de la visite 2 à la visite 10 (sauf pour la visite 5)
    •UCE sur 24 h (marqueur du cuivre) de la visite 2 à la visite 10 (sauf pour la visite 5)
    •NCC* (marqueur du cuivre) de la visite 2 à la visite 10 (sauf pour la visite 5)
    •Cuivre sérique (marqueur du cuivre) de la visite 2 à la visite 10 (sauf pour la visite 5)
    E.5.2Secondary end point(s)
    • Concentration of MAT in plasma
    • Concentration of DAT in plasma
    • AUC0-t, Cmax and Ctrough for trientine and metabolites. (As secondary endpoint, pre-dose concentrations are reported and summarized using NCA. While the pre-dose PK samples
    are collected shortly prior to the next dose, the pre-dose concentration is assumed to approximate the Ctrough.)
    • Number of AEs including number of AEs leading to discontinuation of treatment with
    Cufence
    • Changes in neurological disease status (Unified Wilson’s Disease Rating Scale (UWDRS))
    • Changes in psychiatric symptoms (SCID-5, MMSE, EQ-5D-3L, PHQ-9, PHQ-9-A, CBCL)
    • Changes in hepatic disease (full liver panel to determine the APRI, the Child-Pugh score, the FIB4 index and the New Wilson Index (Dhawan Index), and Fibroscan)
    •Concentration plasmatique de MAT
    •Concentration plasmatique de DAT
    •ASC0-t, Cmax et Cres pour la trientine et ses métabolites. (Comme critère d’évaluation secondaire, les concentrations pré-traitement seront rapportées et résumées à l’aide de NCA. Comme les échantillons PK pré-traitement sont prélevés peu avant la dose suivante, on suppose que la concentration pré-traitement est proche de la Cres.)
    •Nombre d’EI, y compris le nombre d’EI entraînant l’arrêt du traitement par Cufence
    •Modifications de l’état des troubles neurologiques (Échelle unifiée d’évaluation de la maladie de Wilson (UWDRS))
    •Modifications des symptômes psychiatriques (SCID-5, MMSE, EQ-5D-3L, QSP-9, QSP-9-A, LCE)
    •Évolution de l’hépatopathie (bilan hépatique complet pour déterminer l’APRI, le score de Child-Pugh, l’index FIB4 et le nouvel index de Wilson (index de Dhawan), et Fibroscan)
    E.5.2.1Timepoint(s) of evaluation of this end point
    • Concentration of MAT in plasma at Visit 2- Visit 10
    • Concentration of DAT in plasma at Visit 2- Visit 10
    • AUC0-tau, Cmax and Cmin for trientine and metabolites (by NCA) at Visit 2- Visit 10 except Visit 5
    • Number of AEs including number of AEs leading to discontinuation of treatment with Cufence at all visits
    • Changes in neurological disease status (Unified Wilson’s Disease Rating Scale (UWDRS)) at Visit 2,4 and Visit 6-10
    • Changes in psychiatric symptoms (SCID-5, MMSE,
    EQ-5D-3L, PHQ-9, PHQ-9-A, CBCL)-various timepoint for each assessment
    • Changes in hepatic disease (full liver panel to determine the APRI, the Child-Pugh score, the FIB4 index and the New Wilson Index (Dhawan Index), and Fibroscan)
    •Concentration plasmatique de MAT (V2 à V10)
    •Concentration plasmatique de DAT (V2 à V10)
    •ASC0-t, Cmax et Cres pour la trientine et ses métabolites (V2 à V10, sauf V5)
    •Nombre d’EI, y compris le nombre d’EI entraînant l’arrêt du traitement par Cufence à toutes les visites
    •Modifications de l’état des troubles neurologiques (Échelle unifiée d’évaluation de la maladie de Wilson (UWDRS)) à V2, V4 et de V6 à V10
    •Modifications des symptômes psychiatriques (SCID-5, MMSE, EQ-5D-3L, QSP-9, QSP-9-A, LCE) - cela dépend des visites.
    •Évolution de l’hépatopathie (bilan hépatique complet pour déterminer l’APRI, le score de Child-Pugh, l’index FIB4 et le nouvel index de Wilson (index de Dhawan), et Fibroscan)
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 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
    Cufence (Trientine Dihydrochloride)- dose fixée selon le RCP
    Cufence (Trientine Dihydrochloride)- fixed dose as per SmPc
    E.8.2.4Number of treatment arms in the trial2
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA11
    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
    Follow up call 28 days after LVLS.
    Appel de suivi 28 jours après la dernière visite du dernier patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 10
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 4
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 30
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children will have their own age-appropriate informed assent form. Additionally, at least one parent will sign the informed consent form.
    Les enfants auront leur propre formulaire d'assentiment éclairé adapté à leur âge. De plus, au moins un parent signera un formulaire de consentement éclairé.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    This is a Post marketing authorisation phase 4 study and the IMP is already available in France. Therefore, patients who have particiated in the study and would like to continue the same treatment with Cufence are able to do so via their own healthcare provider.
    Il s'agit d'une étude de phase 4 après AMM et le médicament expérimental est déjà disponible en France. Par conséquent, les patients qui ont participé à l'étude et qui souhaitent poursuivre le même traitement avec Cufence peuvent le faire par l'intermédiaire du circuit standard de soin.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-05-10
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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