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    Summary
    EudraCT Number:2018-004072-35
    Sponsor's Protocol Code Number:18-AOIP-01
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-11-06
    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 number2018-004072-35
    A.3Full title of the trial
    Study of the value of early treatment with an endothelin inhibitor (Bosentan) in patients with sudden blindness secondary to giant cell arteritis
    Etude de l’intérêt d’un traitement précoce par un inhibiteur de l’endothéline (Bosentan) chez des patients présentant une cécité brutale secondaire à une artérite à cellules géantes
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the value of early treatment in patients with sudden blindness
    Etude de l’intérêt d’un traitement précoce chez des patients présentant une cécité brutale
    A.3.2Name or abbreviated title of the trial where available
    CECIBO
    CECIBO
    A.4.1Sponsor's protocol code number18-AOIP-01
    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 SponsorCHU de Nice
    B.1.3.4CountryFrance
    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 supportCHU de Nice
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nice
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address4 avenue reine victoria
    B.5.3.2Town/ cityNice
    B.5.3.3Post code06003
    B.5.3.4CountryFrance
    B.5.4Telephone number04 92 03 40 11+33
    B.5.6E-maildrc@chu-nice.fr
    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 BOSENTAN MYLAN
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN SAS
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameBOSENTAN MYLAN
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPBuccal 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
    giant cell arteritis
    artérite à cellules géantes
    E.1.1.1Medical condition in easily understood language
    visual blindness
    Cécité visuelle
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003232
    E.1.2Term Arteritis coronary
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effects of bosentan (endothelin inhibitor), in combination with conventional therapy, in patients with a sudden decrease in visual acuity, either uni or bilaterally, in the acute phase of giant cell arteritis (Horton's disease) , on recovery of visual acuity at 3 months.
    Evaluer les effets du bosentan (inhibiteur de l’endothéline), en adjonction du traitement conventionnel, chez des patients présentant une baisse brutale d’acuité visuelle uni ou bilatérale, à la phase aigüe de l’artérite à cellule géante (maladie de Horton), sur la récupération d’acuité visuelle à 3 mois.
    E.2.2Secondary objectives of the trial
    1. improvement of visual acuity from the first month
    2. improvement of visual field at 3 months
    3. Evaluate the tolerance of the product in this indication
    1. amélioration de l’acuité visuelle dès le premier mois
    2. amélioration du champ visuel à 3 mois
    3. Evaluer de la tolérance du produit dans cette indication
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age > 50 years old
    • Decreased visual acuity (BVA), regardless of degree of severity, sudden onset in the context of newly diagnosed or suspected Horton's disease
    • Diagnostic BAV <58 days
    • Conventional treatment of Horton's disease: Corticosteroids and + - anti-platelet aggregators and / or LMWH at the discretion of the referring physician for his vascularity and + - immunosuppressive or biologic pathology if necessary.
    • Age > 50 ans
    •Baisse d’acuité visuelle uni ou bilatérale (BAV), quelle que soit son degré de sévérité, de survenue brutale dans un contexte de maladie de Horton récemment diagnostiquée ou suspectée
    • BAV de diagnostic < à 5 jours
    • Traitement conventionnel de la maladie de Horton : Corticoïdes et +- anti-agrégants plaquettaires et/ou HBPM à discrétion du médecin référent pour sa pathologie vascularitique et +- immunosuppresseur ou biothérapie si besoin.
    E.4Principal exclusion criteria
    • BAV and ischemia over 5 days
    • Underlying hepatocellular insufficiency known
    • Patient under guardianship or curatorship
    • Hypersensitivity to the active substance or to any of the excipients
    • Moderate to severe hepatic insufficiency corresponding to class B or C of the Child-Pugh classification
    • Serum levels of hepatic aminotransferases, aspartate aminotransferases (ASTs) and / or alanine aminotransferases (ALATs), greater than 3 times the upper limit of normal before start of treatment
    • Patient on cyclosporine A therapy
    • BAV et ischémie de plus de 5 jours
    • Insuffisance hépato-cellulaire sous-jacente connue
    • Patient sous tutelle ou curatelle
    • Hypersensibilité à la substance active ou à l’un des excipients
    • Insuffisance hépatique modérée à sévère correspondant à la classe B ou C de la classification de Child-Pugh
    • Taux sériques des aminotransférases hépatiques, aspartate aminotransférases (ASAT) et/ou alanine aminotransférases (ALAT), supérieurs à 3 fois la limite supérieure de la normale avant la mise en route du traitement
    • Patient sous traitement à la cyclosporine A
    E.5 End points
    E.5.1Primary end point(s)
    Visual acuity measured according to the ETDRS scale at 3 months.
    Acuité visuelle mesurée selon l’échelle ETDRS à 3 mois
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 mois
    E.5.2Secondary end point(s)
    1. Visual acuity score measured according to the ETDRS scale at 1 month
    2. Goldman unilateral visual field at 3 months
    3. Evaluate Serious Adverse Events
    1. Score d’acuité visuelle mesurée selon l’échelle ETDRS à 1 mois
    2. Champ visuel de Goldman unilatéral à 3 mois
    3. Evaluer les EIG
    E.5.2.1Timepoint(s) of evaluation of this end point
    One month and three month
    un mois et trois mois
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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.8.2.4Number of treatment arms in the trial1
    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.8.5.1Number of sites anticipated in the EEA2
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months27
    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: 4
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 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 state8
    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 Decision2018-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-07-26
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