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    Summary
    EudraCT Number:2016-004580-39
    Sponsor's Protocol Code Number:TOSCA_GHDDP
    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:2021-06-01
    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 number2016-004580-39
    A.3Full title of the trial
    Treatment of Growth Hormone Deficiency associated with Chronic Heart Failure: A Randomized, Double-Blind, Placebo-Controlled Study
    TRATTAMENTO DEL DEFICIT DI GH ASSOCIATO AD INSUFFICIENZA CARDIACA CRONICA: STUDIO CLINICO MULTICENTRICO, RANDOMIZZATO, DOPPIO CIECO, PLACEBO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of Growth Hormone Deficiency in patient with Chronic Heart Failure
    TRATTAMENTO DEL DEFICIT DI GH IN PAZIENTI CON INSUFFICIENZA CARDIACA CRONICA.
    A.3.2Name or abbreviated title of the trial where available
    Treatment of Growth Hormone Deficiency associated with Chronic Heart Failure: A Randomized, Double-B
    TRATTAMENTO DEL DEFICIT DI GH ASSOCIATO AD INSUFFICIENZA CARDIACA CRONICA: STUDIO CLINICO MULTICENTR
    A.4.1Sponsor's protocol code numberTOSCA_GHDDP
    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 supportA.O.U Federico II
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationA.O.U FEDERICO II
    B.5.2Functional name of contact pointDIPARTIMENTO DI SCIENZE MEDICHE TR
    B.5.3 Address:
    B.5.3.1Street AddressVIA S. PANSINI
    B.5.3.2Town/ cityNAPOLI
    B.5.3.3Post code80131
    B.5.3.4CountryItaly
    B.5.4Telephone number+390817464375
    B.5.5Fax number+390817464375
    B.5.6E-mailcittadin@unina.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 SAIZEN - 1 FLACONCINO POLV. 8 MG + 1 CARTUCCIA. SOLV. INSERITI IN UN DISPOSITIVO PER LA RICOSTITUZIONE
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SERONO S.P.A.
    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 namesomatropina
    D.3.2Product code [026863100]
    D.3.4Pharmaceutical form Solution for injection
    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 INNSOMATROPINA
    D.3.9.2Current sponsor code H01AC01
    D.3.9.3Other descriptive namesomatropin
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number100
    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) Yes
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Growth Hormone Deficiency associated with Chronic Heart Failure
    DEFICIT DI GH NELL'INSUFFICIENZA CARDIACA CRONICA
    E.1.1.1Medical condition in easily understood language
    Growth Hormone Deficiency in patients with Chronic Heart Failure
    DEFICIT DI GH IN PAZIENTI CON INSUFFICIENZA CARDIACA CRONICA
    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 PT
    E.1.2Classification code 10056438
    E.1.2Term Growth hormone deficiency
    E.1.2System Organ Class 10014698 - Endocrine disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Aim of the current study is to assess the cardiovascular effects of GH replacement therapy in patients with coexisting GHD and CHF
    Indagare gli effetti cardiovascolari della terapia sostitutiva con GH nei pazienti con GHD ed ICC.
    E.2.2Secondary objectives of the trial
    1. Hospitalizations for any cause requiring a ward stay longer than one night
    2. End-systolic LV volumes
    3. NT-proBNP levels
    4. QoL scores
    5. Endothelial function (flow-mediated vasodilation)
    6. Muscle strength (handgrip)
    7. Levels of Endothelial Progenitor Cells (EPCs)
    8. Levels of lymphocyte G protein-coupled receptor kinase (GRK)-2
    • Ospedalizzazione per tutte le cause: definito come degenza in un reparto per più di una notte consecutiva
    • volume telediastolico del VS
    • livelli di NT-pro BNP
    • qualità di vita mediante score QoL
    • funzione endoteliale (mediante vasodilatazione flusso mediata)
    • forza muscolare (handgrip)
    • livelli delle cellule progenitrici endoteliali (EPCs)
    • livelli linfocitari dei recettori chinasi 2 G protein-coupled (GRK-2)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) patients of either sex affected by CHF NYHA class I-III, secondary to ischemic or idiopathic di-lated cardiomyopathy;
    2) age range 18-85 years;
    3) stable and optimal medical therapy for at least three months prior to randomization, including ACE inhibitors or AT1 antagonists and beta-blockers (unless untolerated);
    4) LV ejection fraction 40% or less and LV end-diastolic dimension 55 mm or more;
    5) GH deficiency diagnosed with GHRH + arginine provocative test;
    6) signed informed consent.
    - Pazienti di entrambi i sessi con diagnosi di ICC secondaria a cardiopatia dilatativa post-ischemica o idiopatica, secondo le attuali linee guida, in classe NYHA I-III.
    - Età 18-85 anni
    - Frazione di eiezione del ventricolo sinistro minore o uguale a 40% e diametro del ventricolo sinistro maggiore o uguale a 55 mm.
    E.4Principal exclusion criteria
    1) inability to perform a bicycle exercise test;
    2) poorly controlled diabetes mellitus (HbA1c >8.5) and/or active proliferative or severe non-proliferative diabetic retinopathy;
    3) active and/or history of malignancy: there is no evidence that GH replacement in adults increases the risk of de novo or recurrent malignancy. GH will not be initiated in patients with active neoplasm, either newly diagnosed or recurrent as well as in subjects with a history of cancer shorter than one year. Since growth hormone deficiency may be an early sign of the presence of a pituitary tumor (or, rarely, other brain tumors), the presence of such tumors will be ruled out prior to initiation of treatment. GH therapy will not be used in patients with any evidence of progression or recurrence of an underlying intracranial space-occupying lesion.
    4) unstable angina or recent myocardial infarction (less than six months);
    5) severe liver or kidney disease (serum creatinine levels >2.5 mg/dl)
    6) patients with acute critical illnesses caused by complications of open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure.
    7) active infection or sepsis.
    8) any allergies to growth hormone, or other ingredients such as benzyl alcohol, sucrose, phosphoric acid, sodium hydroxide, or metacresol

    - Incapacità di effettuare un test da sforzo al cicloergometro
    - Diabete mellito in scarso controllo glicometabolico (HbA1c > 8,5%) e/o retinopatia proliferativa o retinopatia non proliferativa di grado severo
    - Insufficienza renale severa (livelli di creatinina > 2,5 mg/dl)
    - Cirrosi epatica avanzata
    - Malattia neoplastica attiva o storia di malignità: non ci sono prove che la sostituzione di GH negli adulti aumenti il rischio di neoplasia de novo o tumore maligno recidivante. La terapia con GH non sarà iniziata in pazienti con neoplasia attiva, sia di nuova diagnosi che ricorrente, nonché in soggetti con una storia di cancro inferiore a un anno. Poiché deficit di ormone della crescita può essere un segno precoce della presenza di un tumore ipofisario (o, raramente, altri tumori cerebrali), la presenza di tali tumori sarà esclusa prima dell'inizio del trattamento. La terapia con GH non sarà utilizzato in pazienti con qualsiasi evidenza di progressione o la reiterazione di lesione intracranica occupante spazio
    - Pazienti con gravi malattie acute causate da complicazioni per interventi chirurgici a cuore aperto o addominali, traumi accidentali multipli, o insufficienza respiratoria acuta
    - Infezione attiva o sepsi.
    - Eventuali allergie a ormone della crescita, o altri eccipienti quali alcool benzilico, saccarosio, acido fosforico, idrossido di sodio, o metacresolo.

    - Sindrome Coronarica Acuta nei 6 mesi precedenti
    E.5 End points
    E.5.1Primary end point(s)
    The objective of the study is to determine whether treatment of GHD improves peak oxygen con-sumption (peak VO2), a recognized surrogate end-point of CHF progression. According to previous observations, we set a target increase of peak VO2 in the treated arm at 3 ml/kg/min at the end of the study
    L’obiettivo dello studio è determinare se il trattamento con GHD migliora il picco di consumo di ossigeno (peak VO2), un importante e riconosciuto end-point surrogato di progressione di ICC. In accordo con le precedenti osservazioni, abbiamo settato come obiettivo peak VO2 di almeno 3 ml/kg/min alla conclusione dello studio
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    Secondary end-points include:
    1. Hospitalizations
    2. End-systolic LV volumes
    3. NT-proBNP levels
    4. QoL scores
    5. Endothelial function (flow-mediated vasodilation)
    6. Muscle strength (handgrip)
    7. Levels of Endothelial Progenitor Cells (EPCs)
    8. Levels of lymphocyte G protein-coupled receptor kinase (GRK)-2
    • ospedalizzazione
    • volume telediastolico del VS
    • livelli di NT-pro BNP
    • qualità di vita mediante score QoL
    • funzione endoteliale (mediante vasodilatazione flusso mediata)
    • forza muscolare (handgrip)
    • livelli delle cellule progenitrici endoteliali (EPCs)
    • livelli linfocitari dei recettori chinasi 2 G protein-coupled (GRK-2)
    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 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 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 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 concerned4
    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 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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 state64
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 64
    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)
    patients may continue the treatment after the end of study if needed
    i pazienti potranno continuare il trattamento dopo il termine dello studio
    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 Decision2018-07-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-07-18
    P. End of Trial
    P.End of Trial StatusOngoing
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