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    Summary
    EudraCT Number:2013-001890-26
    Sponsor's Protocol Code Number:TRACTOR
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-03-27
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2013-001890-26
    A.3Full title of the trial
    Recombinant human parathyroid hormone [rh PTH(1-34): Teriparatide] as therapy for refractory hypoparathyroidism
    Ormone paratiroideo ricombinante umano [rh PTH(1-34): Teriparatide] per il trattamento dell’ipoparatiroidismo refrattario.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Recombinant human parathyroid hormone [rh PTH(1-34): Teriparatide] as therapy for refractory hypoparathyroidism
    Ormone paratiroideo ricombinante umano [rh PTH(1-34): Teriparatide] per il trattamento dell’ipoparatiroidismo refrattario.
    A.4.1Sponsor's protocol code numberTRACTOR
    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 SponsorDipartimento di Medicina e Chirurgia Traslazionale dell’Università degli Studi di Firenze
    B.1.3.4CountryItaly
    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 supportAIFA (Italian Agency on Medicines)
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliero-Universitaria Careggi
    B.5.2Functional name of contact pointSOD Malattie metabolismo minerale e
    B.5.3 Address:
    B.5.3.1Street AddressLargo Palagi, 1
    B.5.3.2Town/ cityFlorence
    B.5.3.3Post code50134
    B.5.3.4CountryItaly
    B.5.4Telephone number0039055794 8087
    B.5.5Fax number0039055794 8320
    B.5.6E-mailmarialuisa.brandi@unifi.it
    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 FORSTEO
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameFORSTEO
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTERIPARATIDE
    D.3.9.1CAS number 52232-67-4
    D.3.9.4EV Substance CodeSUB10925MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/µl microgram(s)/microlitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 40
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Refractory hypoparathyroidism
    Ipoparatiroidismo primario
    E.1.1.1Medical condition in easily understood language
    Refractory hypoparathyroidism
    Ipoparatiroidismo primario
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10021041
    E.1.2Term Hypoparathyroidism
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective:
    Evaluation of the effectiveness of subcutaneous administration of Teriparatide (FORSTEO) as hormone replacement therapy in patients with refractory hypoparathyroidism.



    Obiettivo Primario
    Valutazione dell'efficacia della somministrazione sottocutanea di Teriparatide come terapia ormonale sostitutiva in pazienti con ipoparatiroidismo refrattario, causato da interventi chirurgici (tiroide, paratiroide, chirurgia del collo o altro), cause autoimmunitarie, mutazioni attivanti il recettore sensibile al calcio, cause idiopatiche o anomalie di sviluppo delle ghiandole paratiroidee. Questo studio si propone di valutare l'efficacia clinica di Teriparatide in pazienti con ipoparatiroidismo refrattario in termini di 1) riduzione del dosaggio della supplementazione orale di Ca e vitamina D, 2) mantenimento di livelli stabili di Ca sierico, e 3) miglioramento dell'ipercalciuria.


    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    1) Determination of a more effective treatment than those presently used for patients with refractory hypoparathyroidism.
    2) Creation of treatment guidelines for the use of Teriparatide in patients with refractory hypoparathyroidism.

    Obiettivi secondari
    1) Individuazione di un trattamento più efficace di quelli attualmente utilizzati per i pazienti con ipoparatiroidismo refrattario.
    2) Creazione di linee guida di trattamento per l'uso di teriparatide in pazienti con ipoparatiroidismo refrattario.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.History of hypoparathyroidism for ≥ 18 months post-diagnosis, inclusive of historical biochemical evidence of hypocalcaemia and concomitant serum intact PTH <1,3 pmol/L
    2.Requirement for supplemental oral Ca treatment ≥ 1000 mg per day over and above normal dietary Ca intake.
    3.Capability of providing written informed consent.
    4.Ability to perform daily subcutaneous self-injections of study medication (or have a designee perform injection) via a multidose injection pen into the thigh or abdomen.
    1.Storia in anamnesi di ipoparatiroidismo per > = 18 mesi dopo la diagnosi, comprensivo di evidenza biochimica di ipocalcemia e concomitante PTH sierico intatto <15 pg / mL, tali esami devono essere eseguiti in 2 date con almeno 21 giorni di distanza nei 12 mesi precedenti la randomizzazione.
    2. Assunzione di supplementazione orale di Ca > 1000 mg al giorno, oltre la normale assunzione di Ca con la dieta.
    3. Capacità di fornire consenso informato scritto.
    4. Capacità di effettuare personalmente, o da persone da loro designate, auto-iniezioni del farmaco in studio quotidianamente per via sottocutanea attraverso la penna multidose nella coscia o nell'addome.
    E.4Principal exclusion criteria
    1.Hypoparathyroidism resulting from impaired responsiveness to PTH (pseudohypoparathyroidism).
    2.Any disease that might affect Ca metabolism or Ca/Pi homeostasis other than hypoparathyroidism.
    3.Use of prohibited medications such as loop diuretics, raloxifene hydrochloride, lithium, estrogens, progestins, methotrexate, or systemic corticosteroids within clinical trial optimization and treatment periods.
    4.Epilepsy.
    5.Seizure disorder with a history of a seizure within the previous 6 months before the study.
    6.Presence of open epiphyses.
    7.Any disease/condition that in the opinion of the Investigator has a high probability of precluding the patient from correctly following study requirements and/or completing the study.
    1. Ipoparatiroidismo derivante dalla compromissione della capacità di risposta al PTH (pseudoipoparatiroidismo).
    2. Qualsiasi malattia che potrebbe influenzare il metabolismo del Ca o l'omeostasi del Ca / Pi diverso dall'ipoparatiroidismo.
    3. L'utilizzo di farmaci come: diuretici dell'ansa, raloxifene cloridrato, litio, estrogeni, progestinici, metotrexato, o corticosteroidi sistemici (utilizzati all'interno del periodo di ottimizzazione, sperimentazione clinica e periodi di trattamento).
    4. Epilessia.
    5. Crisi convulsive nei 6 mesi prima il reclutamento nello studio.
    6. Non chiusura completa delle epifisi.
    7. Qualsiasi malattia / condizione, che secondo il parere del ricercatore, impedisca al paziente, con alta probabilità, di seguire correttamente i requisiti di studio e / o il completamento dello studio.
    E.5 End points
    E.5.1Primary end point(s)
    1) to reduce requirements oral Ca and active vitamin D metabolite/analog supplementation administration
    2) to maintain stable serum Ca levels
    3) to control hypercalciuria 24/h



    1) ridurre il fabbisogno di supplementazione orale di calcio e vitamina D o la somminastrazione di analoghe supplementazioni
    2) mantenere livelli sierici di calcio stabili
    3) contollare ipercalciuria /24 ore
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 mesi
    E.5.2Secondary end point(s)
    1) To evaluate the percentage change from Visit 1 in calcium supplementation dosage after 12 weeks of treatment with Teriparatide
    2) The frequency of hypocalcemia clinical symptoms during treatment period.
    1) Valutare il cambiamento del dosaggio di supllementazione di calcio
    2) frequenza di sintomi clinici di ipocalcemia durante il periodo di trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 months
    3 mesi
    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 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 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
    ultima visita dell'ultimo soggetto
    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 months6
    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: 30
    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 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
    Nessuno
    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 Decision2014-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-02-11
    P. End of Trial
    P.End of Trial StatusOngoing
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