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    Summary
    EudraCT Number:2004-000172-13
    Sponsor's Protocol Code Number:20030213
    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:2008-07-10
    Trial results View 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 number2004-000172-13
    A.3Full title of the trial
    AN OPEN LABEL STUDY EVALUATING THE SAFETY AND EFFICACY OF LONG-TERM DOSING OF AMG 531 IN THROMBOCYTOPENIC SUBJECTS WITH IMMUNE (IDIOPATHIC) THROMBOCITOPENIC PURPURA
    Studio in aperto per valutare la sicurezza e l'efficacia del trattamento a lungo termine con AMG 531 in pazienti trombocitopenici con porpora trombocitopenica immune (idiopatica) (ITP)
    A.3.2Name or abbreviated title of the trial where available
    20030213
    A.4.1Sponsor's protocol code number20030213
    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 SponsorAMGEN S.P.A.
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/283
    D.3 Description of the IMP
    D.3.1Product nameAMG531
    D.3.2Product code AMG531
    D.3.4Pharmaceutical form Powder for 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 INNAMG531
    D.3.9.2Current sponsor codeAMG531
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number5
    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 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 Yes
    D.3.11.13.1Other medicinal product typerecombinant protein
    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
    Thrombocytopenia in subjects with ITP
    Trombocitopenia in pazienti affetti da ITP
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10021245
    E.1.2Term Idiopathic thrombocytopenic purpura
    E.1.2System Organ Class 10005329 - Blood and lymphatic system 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 determine the safety of AMG 531 as a long-term treatment in thrombocytopenic subjects with ITP.
    Determinare la sicurezza e la tollerabilita' di AMG 531 come trattamento a lungo termine in pazienti trombocitopenici affetti da ITP.
    E.2.2Secondary objectives of the trial
    • To evaluate the long-term platelet response to AMG 531 • To evaluate possible reductions in the dose of concurrent ITP therapies while receiving AMG 531 • To evaluate changes in Patient Reported Outcomes (PRO) due to the use of AMG 531
    • Valutare la risposta della conta piastrinica nel trattamento a lungo termine con AMG 531
    • Valutare le possibili riduzioni di dose delle altre terapie concomitanti per la ITP mentre il soggetto riceve AMG 531.
    • Valutare i cambiamenti dei questionari sulla qualita' di vita 'Patient Reported Outcomes' (PROs) dovuti all'uso di AMG 531.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Subject previously completed an AMG 531 ITP study • Before any study-specific procedure, the appropriate written informed consent (and assent, if applicable) was obtained
    • Soggetti che hanno precedentemente completato uno studio con AMG 531 sulla ITP.
    • Consenso informato scritto prima di qualsiasi precedura studio- specifica
    E.4Principal exclusion criteria
    Subject has any bone marrow stem cell disorders or new active malignancies diagnosed since enrollment in the previous AMG 531 ITP study • Subject received any alkylating agents within 4 weeks before the Screening visit or anticipated use during the time of the proposed study • Subject is currently enrolled in or has not yet completed at least 4 weeks since ending device or drug trial(s) (other than the previous AMG 531 ITP study), or subject is receiving other investigational agent(s) other than AMG 531. • Subject of childbearing potential is evidently pregnant (eg, positive &#946;-hCG test) or is breast feeding • Subject is not using adequate contraceptive precautions • Subject will not be available for follow-up assessments • Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and does not have a legally-acceptable representative and/or is unable to comply with study procedures
    Pazienti che abbiano una qualsiasi patologia delle cellule staminali del midollo osseo o una nuova diagnosi di tumore attivo rispetto all'arruolamento nello studio precedente con AMG 531.
    • Pazienti che abbiano ricevuto qualsiasi agente alchilante nelle 4 settimane che precedono la visita di screening o di cui si e' a conoscenza che dovranno riceverne durante il corso dello studio.
    • Pazienti attualmente arruolati in un altro studio clinico che hanno ricevuto qualsiasi farmaco sperimentale o dispositivi medici non ancora approvati dalle autorita' regolatorie nelle ultime 4 settimane che precedono lo screening (ad eccezione di AMG 531)
    • Gravidanza o allattamento.
    • Pazienti in eta' fertile che rifiutano di ricorrere a idonei metodi di controllo delle nascite.
    • Pazienti che non si rendano disponibili per le valutazioni di follow-up.
    • Pazienti che, a giudizio del medico, non intendano o non siano in grado di conformarsi alle procedure previste dallo studio.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence of adverse events, including clinically significant changes in laboratory values and incidence of antibody formation
    Incidenza degli eventi avversi, compresi i cambiamenti significativi nei valori di laboratorio e l'incidenza della formazione di anticorpi.
    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) 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 Yes
    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) 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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    Lo studio durera' fino a progressione di malattia, tossicita' inaccettabile, rinuncia o decesso da parte del paziente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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 Yes
    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) Yes
    F.1.1.5Children (2-11years) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 350
    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 Decision2008-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-04-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-20
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