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    Summary
    EudraCT Number:2011-002719-27
    Sponsor's Protocol Code Number:GLU2011FC
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-03-13
    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 number2011-002719-27
    A.3Full title of the trial
    GLUCOSE METABOLISM AND INFLAMMATORY PARAMETERS UNDER IGF-I TREATMENT IN CYSTIC FIBROSIS
    METABOLISMO GLUCIDICO E PARAMETRI INFIAMMATORI DURANTE TRATTAMENTO CON RHIGF-I NELLA FIBROSI CISTICA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECT OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-I ON GLUCOSE TOLERANCE AND AS PREVENTION TOWARDS THE DEVELOPMENT OF CYSTIC FIBROSIS RELATED DIABETES MELLITUS
    EFFETTI DEL FATTORE DI CRESCITA INSULINO-SIMILE DI TIPO 1, RICOMBINANTE UMANO SUL MIGLIORAMENTO DELLA TOLLERANZA GLUCIDICA E COME PREVENTIVO DELL’ EVOLUZIONE VERSO IL DIABETE MELLITO LEGATO ALLA FIBROSI CISTICA
    A.3.2Name or abbreviated title of the trial where available
    RH-IGF-I IN CYSTIC FIBROSIS
    RH-IGF-I NELLA FIBROSI CISTICA
    A.4.1Sponsor's protocol code numberGLU2011FC
    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 SponsorAZIENDA OSPEDALIERA DI PARMA
    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 supportIPSEN
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationComitato Etico Unico per la Provincia di Pram
    B.5.2Functional name of contact pointSegreteria Scientifica
    B.5.3 Address:
    B.5.3.1Street Addressvia Gramsci 14
    B.5.3.2Town/ cityParma
    B.5.3.3Post code43126
    B.5.3.4CountryItaly
    B.5.4Telephone number0521704775
    B.5.5Fax number0521704702
    B.5.6E-mailgideluca@ao.pr.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 INCRELEX*SC 1FL 4ML 10MG/ML
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN SpA
    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.3.4Pharmaceutical 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 INNMECASERMIN
    D.3.9.1CAS number 68562-41-4
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    PATIENTS WITH CYSTIC FIBROSIS
    PAZIENTI AFFETTI DA FIBROSI CISTICA
    E.1.1.1Medical condition in easily understood language
    PATIENTS WITH CYSTIC FIBROSIS
    PAZIENTI AFFETTI DA FIBROSI CISTICA
    E.1.1.2Therapeutic area Diseases [C] - Hormonal diseases [C19]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10011766
    E.1.2Term Cystic fibrosis pancreatic
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate changes in AUCG, AUCI, insulinogenic index, WBISI calculated from an OGTT during the period of treatment, and to assess changes in FPIR and AIR calculated from an IVGTT.
    Verificare i cambiamenti nell’ area sotto la curva per il glucosio (AUCG) e l’insulina (AUCI), l’indice insulino-genico il whole body insulin sensitivity index (WBISI) calcolati dai dati del test da caric orale di glucosio (OGTT) durante il periodo di trattamento e valutare le modificazioni della FPIR e della AIR calcolati dai dati del test da carico endovenoso di glucosio (IVGTT).
    E.2.2Secondary objectives of the trial
    1. To evaluate changes in ESR, hs-CRP, and IL-6 serum concentrations in response to IGF-I treatment.2. To evaluate the changes in IGF-I, IGFBP-1, IGFBP-2 in response to IGF-I treatment.serum concentrations.
    1. Valutare i cambiamenti negli indici di flogosi VES, hs-PCR ed IL-6 in risposta in risposta al trattamento con IGF-I.2. Valutare i cambiamenti nei fattori di crescita insulino-simili e nelle proteine leganti (IGF-I, IGFBP-1, IGFBP-2) nel siero in risposta al trattamento con IGF-I.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    APPROXIMATELY 20 PATIENTS WILL BE ENROLLED CONSECUTIVELY AT THE REGIONAL CYSTIC FIBROSIS CENTRE IN PARMA (HEAD: DR G. PISI) OVER A 6-12 MONTH-PERIOD, BOTH F508DEL HOMOZYGOTE AND HETEROZYGOTE, BOTH WITH NORMAL AND IMPAIRED GLUCOSE TOLERANCE. PATIENTS MUST BE IN STABLE CLINICAL CONDITIONS AT ENROLEMENT.
    SARANNO ARRUOLATI PRESSO IL CENTRO REGIONALE PER LA FIBROSI CISTICA DI PARMA (RESPONSABILE: DR G. PISI) IN UN PERIODO DO 6-12 MESI CIRCA 20 PAZIENTI SIA CON CARATTERIZZAZIONE GENETICA F508DEL IN OMOZIGOSI CHE IN ETEROZIGOSI, SIA CON NORMALE CHE RIDOTTA TOLLERANZA GLUCIDICA. I PAZIENTI DOVRANNO ESSERE IN CONDIZIONI CLINICHE STABILI AL MOMENTO DELL’ARRUOLAMENTO.
    E.4Principal exclusion criteria
    EXCLUSION CRITERIA WILL BE THE PRESENCE OF ACUTE ILLNESS TREATED BY INTRAVENOUS ANTIBIOTICS WITHIN SIX WEEKS PRIOR TO THE STUDY, A 10% DECREASE IN FEV1 COMPARED TO THE PREVIOUSLY RECORDED VALUE, LIVER DYSFUNCTION AND BURKHOLDERIA CEPACIA INFECTION. STEROID AND AZYTROMYCIN TREATMENTS WILL BE CAREFULLY RECORDED AS WELL AS PSEUDOMONAS AERUGINOSA INFECTION FOR FURTHER ANALYSES. PATIENTS AFFECTED BY ANY DEGREE OF DIABETIC RETINOPATHY WILL BE EXCLUDED AS WELL. DISEASE ACTIVITY AT ENROLEMENT AND DURING TREATMENT WILL BE ASSESSED USING THE SCHWACHMAN-KULCZYCKI SCORE, WHICH ASSESSES GENERAL DISEASE ACTIVITY, PHYSICAL EXAMINATION, NUTRITION AND X-RAY FINDINGS (SCHWACHMAN ET AL., 1958). THE SCORE WILL BE ASSESSED BY A SINGLE PHYSICIAN (GP). SUBJECTS WITH A SCORE BELOW 41 WILL BE CONSIDERED UNSUITABLE FOR THE STUDY AND WILL BE EXCLUDED FOR ETHICAL REASONS.
    SARANNO CRITERI DI ESCLUSIONE LA PRESENZA DI UNA CONDIZIONE MORBOSA ACUTA TRATTATA CON ANTIBIOTICI PER VIA ENDOVENOSA NELLE 6 SETTIMANE PRECEDENTI L’ARRUOLAMENTO, UNA RIDUZIONE DEL 10% DEL FEV1 RISPETTO AL PRECEDENTE CONTROLLO, INSUFFICIENZA EPATICA, NFEZIONE DA BURKHOLDERIA CEPACIA, QUALSIASI GRADO DI RETINOPATIA DIABETICA. VERRANNO ESCLUSI SOGGETTI CON SCHWACHMAN-KULCZYCKI SCORE INFERIORE A 41 (MISURA DEL GRADO DI ATTIVITÀ DI MALATTIA). VERRANNO ATTENTAMENTE REGISTRATI I TRATTAMENTI STEROIDEI E CON AZITROMICINA COSÌ COME LE INFEZIONI DA PSEUDOMONAS AERUGINOSA PER ULTERIORI ANALISI .
    E.5 End points
    E.5.1Primary end point(s)
    TO EVALUATE CHANGES IN AREA UNDER THE CURVE FOR BLOOD GLUCOSE CONCENTRATION (AUCG), AREA UNDER THE CURVE FOR INSULIN (AUCI), INSULINOGENIC INDEX(IGI), WHOLE BODY INSULIN SENSITIVITY INDEX (WBISI) CALCULATED FROM AN OGTT DURING THE PERIOD OF TREATMENT
    VALUTARE I CAMBIAMENTI NELL’AREA SOTTESA ALLA CURVA PER LE CONCENTRAZIONI GLUCIDICHE (AUCG), PER L’INSULINA (AUCI), L’INDICE INSULINOGENICO (IGI), L’INDICE DI SENSIBILITÀ INSULINICA SISTEMICO (WBISI) CALCOLATO A PARTIRE DALL’OGTT DURANTE IL PERIODO DI TRATTAMENTO
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 MONTHS
    24 MESI
    E.5.2Secondary end point(s)
    ASSESSMENT OF INDICES OF INSULIN SENSITIVITY SUCH AS HOMEOSTASIS MODEL ASSESSMENT (HOMA)-IR, QUANTITATIVE INSULIN SENSIVITY CHECK (QUICKI), AND THE FASTING GLUCOSE/INSULINE RATIO (FGIR)- ASSESSMENT OF INFLAMMATORY MARKERS- ASSESSMENT OF HOSPITALIZATION RATE FOR INFECTIONS.- SAFETY ENDPOINTS AND ADVERSE EVENTS EVALUATIONS : THE FIRST THREE DAYS OFTREATMENT PATIENTS WILL UNDERGO IGF-I ADMINISTRATION AT THE HOSPITAL WITH GLUCOSE DETECTION 2 TO 4 HOURS AFTER THE INJECTION. THEREFORE PATIENTS WILL RECEIVE A GLUCOMETER TO CONTINUE A REGULAR GLUCOSE MONITORING AT HOME IF NECESSARY. ALL PATIENTS WILL BE TRAINED ON ADEQUATE CARBOHYDRATES INTAKE DURING BREAKFAST.BIOCHEMICAL EVALUATION WILL BE PERFORMED EVERY 3 MONTHS, INCLUDING GLUCOSE DETECTION, AND ABNORMAL LABORATORY FINDINGS WILL BE RECORDED. CHANGES IN FUNDOSCOPIC EXAMINATIONS WILL BE PROMPTLY EVALUATED.BEFORE ENTERING THE PROTOCOL PATIENTS WILL SIGN A INFORMED CONSENT SPECIFYING ANY POSSIBLE ADVERSE EVENT (AE) RELATED TO THE TREATMENT. THEY WILL BE ASKED TO RECORD ANY CLINICAL AE AND TO IMMEDIATELY REFER IT TO THEIR PHYSICIAN WHO’LL BE RESPONSIBLE FOR THE OFFICIAL RECORD OF IT FOLLOWING THE PHARMACOVIGILANCE PROCEDURE. ANY UNDESIRABLE MEDICAL CONDITION OR THE DETERIORATION OF A PRE-EXISTING MEDICAL CONDITION WILL LEAD TO DRUG DISCONTINUATION OR TO A CAREFUL CLINICAL AND BIOCHEMICAL FOLLOW UP ACCORDING TO THE SEVERITY OF THE SINGLE CONDITION.
    VALUTAZIONE DEGLI INDICI DI INSULINO SENSIBILITA TRA CUI HOMEOSTASIS MODEL ASSESSMENT (HOMA)-IR, IL QUANTITATIVE INSULIN SENSIVITY CHECK (QUICKI), E LA FASTING GLUCOSE/INSULIN RATIO (FGIR).ENDPOINT DI SICUREZZA ED EVENTI AVVERSI : DURANTE I PRIMI 3 GIORNI DI TRATTAMENTO LA SOMMINISTRAZIONE DI RHIGF-I AVVERRA’ IN OSPEDALE CON VALUTAZIONE DEI VALORI GLICEMICI DOPO 2-4 ORE DALLA SOMMINISTRAZIONE. SUCCESSIVAMENTE I PAZIENTI RICEVERANNO UN GLUCOMETRO PER MONITORARE LE GLICEMIE CAPILLARI AL DOMICILIO SE NECESSARIO. TUTTI I PAZIENTI VERRANNO ADEGUATAMENTE ISTRUITI SULLA CORRETTA ASSUNZIONE DI CARBOIDRATI CON LA COLAZIONE.LE VALUTAZIONI BIOCHIMICHE VERRANNO ESEGUITE OGNI 3 MESI INCLUSA LA DETERMINAZIONE DEI VALORI GLICEMICI, E VERRANNO REGISTRATE EVENTUALI ANOMALIE NEI RISULTATI. VARIAZIONI NELLA FUNDOSCOPIA VERRANNO PRONTAMENTE VALUTATE.PRIMA DELL’ARRUOLAMENTO AI PAZIENTI VERRA’ SOTTOPOSTO UN CONSENSO INFORMATO IN CUI SONO DESCRITTI I POSSIBILI EVENTI AVVERSI FARMACO-RELATI (AE). AI PAZIENTI VERRA’ CHIESTO DI REGISTRARE QUALSIASI EVENTO E PRONTAMENTE SEGNALARLO AL MEDICO CHE SARA’ RESPONSABILE DELLA REGISTRAZIONE UFFICIALE DEL AE E DELLE PROCEDURE DI FARMACOVIGILANZA. OGNI CONDIZIONE CLINICA DI NEORISCONTRO E OGNI PEGGIORAMENTO DELLA PRE-ESISTENTE PATOLOGIA DI BASE CONDURRANNO ALLA SOSPENSIONE DEL FARMACO O AD UN ATTENTO MONITORAGGIO BIOCHIMICO IN RELAZIONE ALLA SEVERITA’ DELLA SPECIFICA CONDIZIONE. -VALUTAZIONE DEI MARKER INFIAMMATORI - VALUTAZIONE DEL TASSO DI OSPEDALIZZAZIONE PER INFEZIONI
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 MONTHS
    24 MESI
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months24
    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 Yes
    F.1.1Number of subjects for this age range: 11
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 1
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 9
    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 Yes
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    Normal clinical, biochemical follow up and usual pharmacological treatment
    Ripresa del normale follow up clinico, laboratoristico e di trattamento
    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 Decision2011-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-11-15
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