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    Summary
    EudraCT Number:2018-000526-64
    Sponsor's Protocol Code Number:CHRD2115
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-07-16
    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 number2018-000526-64
    A.3Full title of the trial
    Study of total post-thyroidectomy hypocalcemia after preoperative cholecalciferol supplementation
    Etude de l’hypocalcémie post-thyroïdectomie totale après supplémentation pré opératoire en cholécalciférol.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of total post-thyroidectomy hypocalcemia after preoperative cholecalciferol supplementation
    Etude de l’hypocalcémie post-thyroïdectomie totale après supplémentation pré opératoire en cholécalciférol
    A.3.2Name or abbreviated title of the trial where available
    CAVITHY
    A.4.1Sponsor's protocol code numberCHRD2115
    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 SponsorHospital Center René Dubos
    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 supportHospital Center René Dubos
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Center René Dubos
    B.5.2Functional name of contact pointClinical research unit
    B.5.3 Address:
    B.5.3.1Street Address6 avenue de l’Ile de France
    B.5.3.2Town/ cityCERGY PONTOISE
    B.5.3.3Post code95300
    B.5.3.4CountryFrance
    B.5.4Telephone number00330130754131
    B.5.5Fax number00330130754943
    B.5.6E-mailmaryline.delattre@ght-novo.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 UVEDOSE 100 000 UI
    D.2.1.1.2Name of the Marketing Authorisation holder75019
    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.3.4Pharmaceutical form Oral solution in single-dose container
    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
    Thyroidectomy is a common operation. Transient postoperative hypocalcemia is the main complication, resulting in clinical discomfort for patients, longer hospital stays and increased perioperative cost. Cholecalciferol is used to supplement vitamin D deficiency. We suppose that systematic pre-operative supplementation with cholecalciferol would allow a faster and more appropriate response to post-operative hypocalcemia.
    L’hypocalcémie post opératoire transitoire est la principale complication de la thyroïdectomie avec comme conséquence une gêne clinique pour les patients, un allongement de la durée d’hospitalisation et une augmentation du coût péri-opératoire. Le cholécalciférol est utilisé pour supplémenter les carences en vitamine D. Nous supposons qu’une supplémentation systématique pré opératoire par cholécalciférol permettrait une réponse plus rapide et plus appropriée à l’hypocalcémie post opératoire.
    E.1.1.1Medical condition in easily understood language
    We suppose that taking cholecalciferol before total removal of the thyroid would reduce the occurrence of postoperative hypocalcemia
    Nous supposons que la prise de cholécalciférol avant l'ablation totale de la thyroïde réduirait la survenue d'hypocalcémie postopératoire
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10020949
    E.1.2Term Hypocalcemia
    E.1.2System Organ Class 100000004861
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10043777
    E.1.2Term Thyroidectomy total
    E.1.2System Organ Class 100000004865
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Assessment of the effect of pre-operative cholecalciferol supplementation on the occurrence of post-operative hypocalcemia after total thyroidectomy
    Evaluation de l’effet d’une supplémentation par Uvédose® (cholécalciférol) en pré opératoire sur la survenue d’une hypocalcémie post opératoire.
    E.2.2Secondary objectives of the trial
    Group Treatment vs group no treatment:
    Assessment of length of hospital stay and readmissions during follow-up
    Assessment of severity of hypocalcemia
    Assessment of the effect of supplementation on vitamin D deficiency
    Assessment of parathyroid activity

    All the patients:
    Assessment of the prevalence of definitive hypocalcemia
    Assessment of the effect of vitamin D supplementation on the occurrence of hypocalcemia in risk groups: hyperthyroidism, cancer, dissection associated with thyroidectomy
    Bras expérimental versus bras contrôle :
    - Evaluation de la durée d’hospitalisation et des réadmissions au cours du suivi
    - Evaluation de la sévérité de l’hypocalcémie
    - Evaluation de l’effet de la supplémentation sur les carences en vitamine D
    - Evaluation de l’activité parathyroidienne
    Pour tous les patients :
    - Evaluation de la prévalence des hypocalcémies définitives
    - Evaluation de l’effet de la supplémentation sur la survenue des hypocalcémies dans les groupes à risque : hyperthyroïdie, cancer, réalisation d’un curage associé à la thyroïdectomie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patient ≥ 18 years old
    Patient shall be operated on for a total thyroidectomy in one time for any indication
    Written informed consent (IC) obtained
    Patients with affiliation to the social security system
    Patient âgé de plus de 18 ans
    Devant être opéré d’une thyroïdectomie totale en un temps quelle que soit l’indication.
    Informé et ayant signé un consentement
    Bénéficiaire d’un régime de sécurité sociale (ou ayant droit)
    E.4Principal exclusion criteria
    Medical history of :
    - thyroid or parathyroid surgery
    - Hyperparathyroidism
    - granulomatosis flare-up
    Chronic kidney disease grade ≥4
    25OHD supplementation within last 3 months before surgery
    Malabsorption syndrome
    Known hypersensitivity to vitamin D
    Medical history of calcic lithiasis
    Hypocalcemia, hypercalcemia/ hypercalciuria, or symptom of Hypocalcemia, hypercalcemia/ hypercalciuria, not due to thyroid pathologies
    Severe liver failure
    Pregnant women
    Vulnerable populations (guardianship or trusteeship)
    Persons deprived of their liberty by court or administrative decision
    Antécédents de :
    o chirurgie thyroïdienne ou parathyroïdienne
    o hyperparathyroïdie
    o granulomatose en poussée
    Ayant une insuffisance rénale chronique de grade ≥4
    Ayant reçu une supplémentation de 25OHD dans les 3 derniers mois qui précèdent la chirurgie
    Atteint d’une pathologie de malabsorption
    Hypersensibilité connue à la vitamine D
    Antécédent de lithiase calcique
    Patients avec une hypocalcémie ou une hypercalcémie/hypercalciurie ou des symptômes d’hypocalcémie, hypercalcémie/hypercalciurie liés à d’autres pathologies autres que les pathologies thyroïdiennes
    Ayant une insuffisance hépatique sévère
    Femmes enceintes
    Patients protégés (tutelle / curatelle)
    Personnes privée de liberté par décision de justice ou administrative
    E.5 End points
    E.5.1Primary end point(s)
    Measure of the occurrence of serum and / or clinical hypocalcemia
    Serum hypocalcemia is defined by a level of calcemia, corrected for albuminemia, of less than 2.00 mmol / L.
    Clinical hypocalcemia is defined by the appearance of one of the following signs: sign of Chvostek, sign of Trousseau, paresthesias of the extremities and perioral between surgery and D15
    Le critère d’évaluation principal est la survenue d’une hypocalcémie sérique et/ou clinique entre la chirurgie (J0) et J15. L’hypocalcémie sérique est définie par un seuil de calcémie corrigée sur l’albuminémie inférieur à 2,00 mmol/L. L’hypocalcémie clinique est définie par l’apparition d’un des signes suivants: signe de Chvostek, signe de Trousseau, paresthésies des extrémités et péribuccales.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Fifteen days after surgery
    Quinze jours après l'opération
    E.5.2Secondary end point(s)
    Duration of initial hospitalization (number of hospital days), collect of adverse events and number of readmissions
    Measure of severity of hypocalcemia defined by a calcemia corrected for albuminemia of less than 1.90 mmol / L and / or the use of calcium gluconate IV in the first 15 post-operative days.
    Measure of duration of hypocalcemia's symptoms in the first 15 days postoperative
    Vitamin D deficiency will be measured by comparing the initial value of 25OHD at the inclusion visit to the value of 25OHD of the day of the operation (D0=H0)
    Collect of the number of adverse events and serum calcium levels for each participant
    Collect of the definitive hypocalcemia’s numbers in each group
    Parathyroid activity will be evaluated in both group by measuring parathormone (PTH). Hypoparathyroidism being defined by PTH < 15 ng / L.
    Durée de l’hospitalisation initiale, recueil des évènements indésirables et des ré-hospitalisations.
    Sévérité de l’hypocalcémie définie par une calcémie corrigée sur l’albuminémie inférieure à 1,90 mmol/L mesurée à J1, J2 et J15 et/ ou l’utilisation de gluconate de calcium IV dans les 15 premiers jours post opératoires.
    Durée des symptômes de l’hypocalcémie dans les 15 premiers jours post opératoires.
    La carence en vitamine D sera mesurée par dosage de la 25OHD en comparant la valeur initiale à la visite d’inclusion à celle du jour de l’opération (J0-H0)
    Recueil des pathologies à risque et mesure de la calcémie
    Nombre d’hypocalcémie définitive
    L’activité parathyroïdienne sera évaluée par la mesure de la PTH avant l’opération (J0-Chirurgie), à H4, J2 et J15. L’hypoparathyroïdie étant définie par la PTH < 15 ng/L.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At M3
    A M3
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    Sans médicament
    Without medicinal product
    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 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
    Dernière visite du dernier patient
    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 months6
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state200
    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
    Non applicable
    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 Decision2020-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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