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    Summary
    EudraCT Number:2011-003687-78
    Sponsor's Protocol Code Number:IPF/LANREOTIDE/2011-01
    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:2012-03-05
    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 number2011-003687-78
    A.3Full title of the trial
    Lanreotide Autogel for the treatment of patients with Idiopathic Pulmonary Fibrosis (IPF)
    LANREOTIDE AUTOGEL NELTRATTAMENTO DEI PAZIENTI CON FIBROSI POLMONARE IDIOPATICA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Lanreotide Autogel for the treatment of patients with Idiopathic Pulmonary Fibrosis (IPF)
    LANREOTIDE AUTOGEL NELTRATTAMENTO DEI PAZIENTI CON FIBROSI POLMONARE IDIOPATICA
    A.3.2Name or abbreviated title of the trial where available
    IPF/LANREOTIDE/2011-01
    IPF/LANREOTIDE/2011-01
    A.4.1Sponsor's protocol code numberIPF/LANREOTIDE/2011-01
    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 BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
    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 organisationAOU di Bologna
    B.5.2Functional name of contact pointU.O. Medicina Interna-Tomassetti
    B.5.3 Address:
    B.5.3.1Street AddressVia Albertoni 15
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.4Telephone number051/6364186
    B.5.5Fax number051/6364186
    B.5.6E-mailpaola.tomassetti@unibo.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.2.1.2Country 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 INNLANREOTIDE ACETATE
    D.3.9.1CAS number 127984-74-1
    D.3.9.4EV Substance CodeSUB14326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 No
    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 nameGallium68-Dota-Noc
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor code68Gallio-DOTA-NOC
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number185
    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 Yes
    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
    Idiopathic Pulmonary Fibrosis
    Fibrosi polmonare interstiziale idiopatica
    E.1.1.1Medical condition in easily understood language
    Idiopathic Pulmonary Fibrosis
    Fibrosi polmonare interstiziale idiopatica
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10021240
    E.1.2Term Idiopathic pulmonary fibrosis
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    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 use of Lanreotide Autogel for the treatment of patients with IPF. In particular, primary aim of the study is to assess whether Lanretoitde Autogel therapy is able to improve or stabilize pulmonary function parameters (DLCO and FVC), considered as markers of disease state in international guidelines. Disease progression is defined by a reduction of >15% of DLCO with or without associated reduction of >10% FVC as compared to baseline values. Data will also be compared to a historical group of IPF patients treatment with standard regimen
    Descrivere il miglioramento o la stabilizzazione dei parametri di funzionalità polmonare in pazienti trattati con Lanreotide Autogel. In particolare il DLCO e la FVC saranno utilizzati come marker dello stato di malattia secondo quanto descritto dalle linee guide ATS. Sarà definita come progressione di malattia una riduzione del DLCO &gt; 15% con o meno una riduzione dell’FVC &gt;10% rispetto al basale
    E.2.2Secondary objectives of the trial
    1) evaluate Lanreotide Autogel in improving overall survival in patients with IPF 2) assess the capacity of Lanreotide Autogel in reducing the number of disease reacutizations in patients with IPF (reported incidence of reacutization estimated by the American Thoracic Society is approximately 5-10% ) 3) evaluate whether 68Ga-DOTA-NOC PET/CT SUVmax could be employed as a valuable non invasive parameter to select patients with higher somatostatin receptors expression that are more likely to respond to Lanreotide Autogel treatment. 4) assess Lanreotide Autogel efficacy in stabilizing disease extension on HRTC 5) assess Lanreotide Autogel toxicity in patients with IPF.
    1) valutare la sopravvivenza (overall survival) nei pazienti con IPF trattati con Lanreotide Autogel; 2) valutare la capacità del Lanreotide Autogel nel ridurre il numero delle riacutizzazioni nei pazienti con IPF (incidenza di riacutizzazioni stimata dall’ATS pari a circa il 5-10% ) 3) valutare se il 68Ga-DOTA-NOC PET/CT SUVmax può essere utilizzato come strumento per selezionare i pazienti con più alta espressione recettoriale e che quindi potrebbero rispondere meglio al trattamento con Lanreotide Autogel 4) valutare l’efficacia di Lanreotide Autogel nello stabilizzare l’estensione di malattia alla HRTC 5) valutare il profilo di tollerabilità di lanreotide nei pazienti con IPF.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF) 2. Age > 30, <75 3. Life expenctancy of more than 1 year 4. DLCO%>40% 5. expression of somatostatin receptors assessed by 68Ga-DOTA-NOC PET/CT 6. Adeguate bone marrow function, normal hepatic and kidney function, assessed by tests performed within the 14 days before starting treatment: leukocytes>3.000/µl, neutrophils (ANC) >1.500/µl, paltelets>100.000/µl, bilirubin <1.5 times the normal upper (ULN), AST(SGOT) and ALT(SGPT) <2.5xULN, creatinin <1.25xULN (or >1.25xULN and <1.5xULN con creatinin clearance>60ml/min). 7. Signed Informed Consent
    • Età &gt;30 e  75 anni • Diagnosi clinica e radiologica di IPF basata sui criteri ATS (1). I prelievi bioptici saranno considerati come opzionali. • DLCO%&gt;40% valutato dalla Pneumologia e Terapia Intensiva Respiratoria del Policlinico S. Orsola Malpigli. • Espressione dei SSTR mediante captazione alla PET/CT con 68Ga-DOTA-NOC • Aspettativa di vita superiore ai 12 mesi • Funzione midollare adeguata, funzione epatica e renale valutata con I seguenti criteri laboratoristici raccolti entro 14 giorni prima dell’inizio dello studio: conta leucociti &gt;3.000/µl, conta assoluta dei neutrofili (ANC) &gt;1.500/µl, conta piastrinica &gt;100.000/µl, bilirubina totale &lt;1.5 volte il limite superiore (ULN), AST(SGOT) and ALT(SGPT) &lt;2.5xULN, creatinina sierica &lt;1.25xULN (or &gt;1.25xULN and &lt;1.5xULN con clearance della creatinina&gt;60ml/min) • Ottenimento del consenso informato
    E.4Principal exclusion criteria
    1. Pregnancy 2. Breast feeding 3. Healthy volunteers 4. Age <30, >75 years 5. Other forms of Interstitial lung disorders 6. Patients in emergency state 7. Individuals with reduced approval competence expressing any reluctance to participate to the study as well as those not understanding the purpose of the study 8. Severe cardiovascular conditions: stroke (6 mesi), AMI (6 mesi), astable angina, heart congestive failure NYHAII or higher, serious arythmias requiring treatment 9. Concomitant inflammatory disorders 10. Severe Parkinson disease 11. Colelithiasis 12. Informed consent not signed 13. Concomitant or recent neoplastic
    • Altre forme di polmonite interstiziale (ILD) • Malattie cardiovascolari signfictive p.e. ictus (6 mesi), infarto miocardio (6 mesi), angina instabile, scompenso cardiaco in classe NYHA II o maggiore, aritmie cardiache che richiedono un trattamento medico • Intercorrenti o non controllate patologie infiammatorie acute • Condizioni psicologiche o sociali che possono alterare la compliance alo studio • Malattia di Parkinson severa • Storia di colelitiasi • Altre neoplasie concomitanti o diagnosticate entro 5 anni dall’arruolamento ad eccezione del carcinoma a cellule basali o cancro in situ della cervice • Donne in gravidanza e donne in allattamento; • Nota o sospetta ipersensibilità al farmaco o alla classe farmacologica in studio; • Pazienti con gravi condizioni cliniche che, a giudizio dello sperimentatore, controindicano la partecipazione del paziente allo studio; • Precedente utilizzo di analoghi long acting della somatostatina • Trattamento sistemico con qualsiasi altro farmaco sperimentale durante i 30 giorni precedenti l’arruolamento.
    E.5 End points
    E.5.1Primary end point(s)
    To assess Lanreotide Autogel use in promoting improvement or stabilization of DLCO and FVC, markers of disease progression according to the American Thoracic Society guidelines. Disease progression is defined by a reduction of >15% of DLCO with or without associated reduction of >10% FVC as compared to baseline values.
    valutare il DLCO e la FVC come marker dello stato di malattia secondo quanto descritto dalle linee guide ATS. Sarà definita come progressione di malattia una riduzione del DLCO > 15% con o meno una riduzione dell’ FVC >10% rispetto al basale
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    1) evaluate Lanreotide Autogel in improving overall survival in patients with IPF 2) assess the capacity of Lanreotide Autogel in reducing the number of disease reacutizations in patients with IPF (reported incidence of reacutization estimated by the American Thoracic Society is approximately 5-10% ) 3) evaluate whether 68Ga-DOTA-NOC PET/CT SUVmax could be employed as a valuable non invasive parameter to select patients with higher somatostatin receptors expression that are more likely to respond to Lanreotide Autogel treatment. 4) assess Lanreotide Autogel efficacy in stabilizing disease extension on HRTC 5) assess Lanreotide Autogel toxicity in patients with IPF.
    1) valutare la sopravvivenza (overall survival) nei pazienti con IPF trattati con Lanreotide Autogel; 2) valutare la capacità del Lanreotide Autogel nel ridurre il numero delle riacutizzazioni nei pazienti con IPF (incidenza di riacutizzazioni stimata dall’ATS pari a circa il 5-10% ) 3) valutare se il 68Ga-DOTA-NOC PET/CT SUVmax può essere utilizzato come strumento per selezionare i pazienti con più alta espressione recettoriale e che quindi potrebbero rispondere meglio al trattamento con Lanreotide Autogel 4) valutare l’efficacia di Lanreotide Autogel nello stabilizzare l’estensione di malattia alla HRTC 5) valutare il profilo di tollerabilità di lanreotide nei pazienti con IPF.
    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 No
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    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 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.8.6 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 months36
    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.1.1Number of subjects for this age range: 0
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state10
    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)
    NA
    NA
    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 Decision2012-02-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-13
    P. End of Trial
    P.End of Trial StatusOngoing
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