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    Summary
    EudraCT Number:2017-001261-25
    Sponsor's Protocol Code Number:T3T42017
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-001261-25
    A.3Full title of the trial
    PHARMACOLOGICAL, NO PROFIT, PROSPECTIVE RANDOMIZED, DOUBLE-BLIND PLACEBO, CONTROLLED STUDY TO EVALUATE THE EFFICACY OF LEVOTHYROXINE AND LIOTIRONINE (LT4+LT3) IN POST-SURGICAL HYPOTHYROIDISM PATIENTS: EFFECTS ON METABOLIC AND CARDIAC PARAMETERS AND QUALITY OF LIFE
    STUDIO PROSPETTICO RANDOMIZZATO IN DOPPIO CIECO CONTROLLATO CON PLACEBO SULLA TERAPIA COMBINATA CON L-TIROXINA E LIOTIRONINA NELL¿IPOTIROIDISMO POST-CHIRURGICO: EFFETTI SUI PARAMETRI METABOLICI, CARDIOVASCOLARI E SULLA QUALIT¿ DI VITA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY TO EVALUATE THE EFFICACY OF LEVOTHYROXINE AND LIOTIRONINE IN POST-SURGICAL HYPOTHYROIDISM PATIENTS: EFFECTS ON METABOLIC AND CARDIAC PARAMETERS AND QUALITY OF LIFE
    STUDIO SULLA TERAPIA CON CON L-TIROXINA E LIOTIRONINANELL¿IPOTIROIDISMO POST-CHIRURGICO: EFFETTI SUI PARAMETRI METABOLICI, CARDIOVASCOLARI E SULLA QUALIT¿ DI VITA
    A.3.2Name or abbreviated title of the trial where available
    T3T42017
    T3T42017
    A.4.1Sponsor's protocol code numberT3T42017
    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 SponsorAOU FEDERICO II
    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 supportIBSA
    B.4.2CountrySwitzerland
    B.4.1Name of organisation providing supportFondi della struttura
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU FEDERICO II
    B.5.2Functional name of contact pointDipartimento di Medicina Clinica e
    B.5.3 Address:
    B.5.3.1Street Addressvia Sergio Pansini 5
    B.5.3.2Town/ cityNapoli
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number0039 0817463695
    B.5.5Fax number0039 0817463695
    B.5.6E-mailbebiondi@libero.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 LIOTIR - 20 MCG / ML GOCCE ORALI, SOLUZIONE FLACONE 20 ML
    D.2.1.1.2Name of the Marketing Authorisation holderIBSA FARMACEUTICI ITALIA S.R.L.
    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 nameLiotir
    D.3.2Product code H03AA02
    D.3.4Pharmaceutical form Oral drops, solution
    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 INNLIOTIRONINA SODICA
    D.3.9.2Current sponsor codeH03AA02
    D.3.9.3Other descriptive nameLiothyronine sodium
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    POST-SURGICAL HYPOTHYROIDISM
    IPOTIROIDISMO POST-CHIRURGICO
    E.1.1.1Medical condition in easily understood language
    POST-SURGICAL HYPOTHYROIDISM
    IPOTIROIDISMO POST-CHIRURGICO
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10036429
    E.1.2Term Postsurgical hypothyroidism
    E.1.2System Organ Class 100000004863
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of combined therapy with LT4+LT3 vs LT4+placebo on thyroid function (TSH, FT3, FT4, FT4/FT3 ratio), metabolic and cardiovascular parameters in patients with post-surgical hypothyroidism.
    Valutazione dell¿ effetto della terapia combinata LT4+LT3 vs LT4+placebo sui parametri di funzione tiroidea (TSH, FT3, FT4 e rapporto FT3/FT4), sull¿assetto cardiovascolare ( parametri ecocardiografici), parametri metabolici
    (variazioni di peso , conferenza vita e circonferenza fianchi, variazioni della massa magra
    alla biompedenziometria (BIA), valutazione del profilo lipidico: colesterolo totale,
    colesterolo LDL, colesterolo HDL, trigliceridi, , glicemia, insulinemia e Homa index)
    oltre alla valutazione di eventuali effetti collaterali a breve termine (effetti sulla pressione
    arteriosa, frequenza cardiaca ed eventuali aritmie sopraventricolari).
    E.2.2Secondary objectives of the trial
    Evaluation of the efficacy and risk/ benefit of LT4+LT3 vs LT4+placebo on symptoms and signs of hypothyroidism and quality of life
    - Evaluation of patients compliance during combined therapy with LT4+LT3 (LT3 administrated twice daily and L-T4 once daily in the morning)
    Valutazione del rischio/beneficio della terapia in termini di effetti collaterali durante il
    trattamento a lungo termine , tollerabilit¿, efficacia della terapia combinata LT4+LT3 vs
    LT4+placebo, persistenza di sintomi e segni di ipotiroidismo , qualit¿ di vita e valutazione
    della compliance del paziente alla terapia combinata con LT4+LT3 (LT3 in doppia somministrazione quotidiana in associazione alla LT4 in mono-somministrazione mattutina).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age between 18 and 50 years
    - Patients with diagnosis of post-surgical hypothyroidism after total thyroidectomy for nodular goiter or differentiated thyroid cancer
    - Patients in therapy with LT4 with biochemical euthyroidism (TSH 1.5 -2,5 mIU/L)
    - Patients able to give informed consent
    - Età compresa tra 18-50 anni
    - Ipotiroidismo post-chirurgico (tiroidectomia totale per patologia nodulare benigna o per carcinoma tiroideo)
    -Terapia farmacologica con L-Tiroxina con eutiroidismo biochimico (I livelli di TSH dei
    pazienti ipotiroidei durante l’arruolamento saranno compresi tra 1.5 -2,5 mIU/L in accordo
    con l’età di inclusione dei pazienti arruolati .
    - Pazienti in grado di comprendere il consenso informato
    E.4Principal exclusion criteria
    - Patients with metastatic differentiated thyroid carcinoma
    - Post surgical hypoparathyroidism
    - Current major medical disorders (renal, hepatic, neurologic or psychiatric diseases, diabetes mellitus)
    - Cardiovascular disease (arterial hypertension, atrial or ventricular arrhythmias, shortened P-R interval, coronary heart disease, heart failure)
    -Gastrointestinal disease: malabsorption syndromes (celiac disease, lactose intolerance) and gastric diseases (gastroesophageal reflux disease, autoimmune gastritis, Helicobacter pylori gastritis)
    - Administration of drugs interfering with LT4 absorption, drugs that increase gastric PH (antacids such as proton pump inhibitors and H2 receptor antagonists...) or may have an altered clearance of LT4 or deiodinase activity
    - Pregnancy
    - Age < 18 and age >50 years
    - Carcinoma tiroideo metastatico
    - Ipoparatiroidismo post-chirurgico
    - Patologie sistemiche (renali, epatologiche, neurologiche e psichiatriche, obesità, diabete mellito)
    - Patologie cardiovascolari (ipertensione arteriosa, coronaropatie, aritmie cardiache, PR breve all’ECG, insufficienza cardiaca)
    - Malattie gastroenterologiche: sindromi da malassorbimento (celiachia, intolleranza al lattosio) e patologie gastriche (malattia da reflusso gastroesofageo, gastrite atrofica, gastrite Helicobacter pylori correlata)
    - Assunzione di farmaci che interferiscono con l’assorbimento intestinale, che modifichino il PH gastrico (inibitori di pompa protonica, antiacidi ecc) , che alterino il metabolismo o la clearance della tiroxina o che abbiano azioni sulle desiodasi
    - Gravidanza ed allattamento
    - Età <18 anni ed età >50 anni
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy of combined therapy with LT4+LT3 vs LT4+placebo on thyroid function (TSH, FT3, FT4, FT4/FT3 ratio), metabolic and cardiovascular parameters in patients with post-surgical hypothyroidism.
    Valutazione dell’ effetto della terapia combinata LT4+LT3 vs
    LT4+placebo sui parametri di funzione tiroidea (TSH, FT3, FT4 e rapporto FT3/FT4),
    sull’assetto cardiovascolare ( parametri ecocardiografici), parametri metabolici
    (variazioni di peso , conferenza vita e circonferenza fianchi, variazioni della massa magra
    alla biompedenziometria (BIA), valutazione del profilo lipidico: colesterolo totale,
    colesterolo LDL, colesterolo HDL, trigliceridi, , glicemia, insulinemia e Homa index)
    oltre alla valutazione di eventuali effetti collaterali a breve termine (effetti sulla pressione
    arteriosa, frequenza cardiaca ed eventuali aritmie sopraventricolari).
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    Evaluation of the efficacy and risk / benefit of LT4+LT3 vs LT4+placebo on symptoms and signs of hypothyroidism and quality of life - Evaluation of patients compliance during combined therapy with LT4+LT3 (LT3 administrated twice daily and L-T4 once daily in the morning)
    Valutazione del rischio/beneficio della terapia in termini di effetti collaterali durante il
    trattamento a lungo termine , tollerabilit¿, efficacia della terapia combinata LT4+LT3 vs
    LT4+placebo, persistenza di sintomi e segni di ipotiroidismo , qualit¿ di vita e valutazione
    della compliance del paziente alla terapia combinata con LT4+LT3 (LT3 in doppia
    somministrazione quotidiana in associazione alla LT4 in mono-somministrazione
    mattutina)
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months
    12 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 No
    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) 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 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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA1
    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 Information not present in EudraCT
    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
    LVLS
    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 months24
    E.8.9.1In the Member State concerned days73
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months24
    E.8.9.2In all countries concerned by the trial days73
    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: 86
    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 state86
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 86
    F.4.2.2In the whole clinical trial 86
    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)
    therapy with LT4 + LT3 will be continued by patients
    la terapia con LT4+ LT3 sar¿ continuata dai pazienti
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Clinical Research Technology
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-27
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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