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    Summary
    EudraCT Number:2008-004347-10
    Sponsor's Protocol Code Number:20080009
    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:2009-09-16
    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 number2008-004347-10
    A.3Full title of the trial
    A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP.
    Studio prospettico, di Fase IV, in aperto, multicentrico, di valutazione delle variazioni della morfologia del midollo osseo in soggetti trattati con romiplostim per Trombocitopenia associata a Porpora Trombocitopenica Immune (Idiopatica) (ITP.
    A.4.1Sponsor's protocol code number20080009
    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 Inc.
    B.1.3.4CountryUnited States
    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 Yes
    D.2.1.1.1Trade name NPLATE
    D.2.1.1.2Name of the Marketing Authorisation holderAMGEN EUROPE B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/008/05
    D.3 Description of the IMP
    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 INNROMIPLOSTIM
    D.3.9.2Current sponsor codeAMG 531
    D.3.10 Strength
    D.3.10.1Concentration unit µg/kg microgram(s)/kilogram
    D.3.10.3Concentration number10
    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 typeproteina ricombinante
    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 associated with ITP
    Trombocitopenia associata a 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 evaluate the incidence of collagen fibrosis as evidenced by trichrome staining at Year 1, Year 2, or Year 3 after initial exposure to romiplostim.
    Valutare l`incidenza di fibrosi collagenica, evidenziata mediante colorazione tricromica all`anno 1, all`anno 2 o all`anno 3 dopo l`esposizione iniziale a romiplostim.
    E.2.2Secondary objectives of the trial
    To evaluate the presence of collagen fibrosis as evidenced by trichrome staining 12 weeks after romiplostim discontinuation in subjects who developed collagen fibrosis at Year 1, Year 2, or Year 3 after exposure of romiplostim. To evaluate the incidence of increased reticulin fibrosis as evidenced by silver staining at Year 1, Year 2, or Year 3 after exposure of romiplostim. To evaluate electrocardiogram (ECG) changes after exposure to romiplostim. To evaluate the incidence of cytopenias (anemia or neutropenia) after exposure to romiplostim. To evaluate the overall safety as evidenced by adverse events and the development of neutralizing antibodies to romiplostim or cross-reacting antibodies to endogenous thrombopoietin.
    Valutare la presenza di fibrosi collagenica,evidenziata mediante colorazione tricromica,12 settimane dopo l`interruzione di romiplostim in soggetti che hanno sviluppato fibrosi collagenica all`anno 1,all`anno 2 o all`anno 3 dopo l`esposizione iniziale a romiplostim.Valutare l`incidenza dell`aumento di fibrosi reticolinica,evidenziata mediante colorazione argentica,all`anno 1,all`anno 2 o all`anno 3 dopo l`esposizione a romiplostim.Valutare le variazioni dell`elettrocardiogramma (ECG) dopo esposizione a romiplostim.Valutare l`incidenza di citopenie (anemia o neutropenia) dopo esposizione a romiplostim.Valutare la sicurezza complessiva,indicata dagli effetti indesiderati e dallo sviluppo di anticorpi neutralizzanti romiplostim o di anticorpi cross reagenti con la trombopoietina endogena.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    `Diagnosis of ITP according to the American Society of Hematology (ASH) guidelines `Subject must have had a bone marrow biopsy within one year prior to planned first dose of romiplostim (with available bone marrow tissue block or unstained histological slides to send to a central laboratory for interpretation) or must consent to a pre-treatment bone marrow biopsy within 3 weeks prior to planned first dose of romiplostim. Central laboratory interpretation is required prior to first dose of romiplostim `Baseline bone marrow reticulin grade of 0, 1, 2 or 3 according to the modified Bauermeister grading scheme as assessed by central laboratory interpretation `Subject must agree to a scheduled bone marrow biopsy at Year 1, Year 2, or Year 3 following romiplostim treatment and any unscheduled biopsies if clinically indicated `Subject platelet count is < 50x 109/L `Subject > 18 years of age `Must have received at least 1 prior ITP therapy (examples of ITP therapy include corticosteroids, IVIG, splenectomy) `Subject (or legally-acceptable representative) is willing and able to provide written informed consent
    `Diagnosi di ITP secondo le linee guida della American Society of Hematology (ASH) `Il soggetto deve essere stato sottoposto a biopsia del midollare osseo nell`anno precedente la prima dose programmata di romiplostim (con la disponilbilita` di un blocco di tessuto midollare o sezioni istologiche non colorate da inviare a un laboratorio centralizzato per la loro interpretazione) oppure deve acconsentire a sottoporsi a una biopsia midollare pretrattamento nelle 3 settimane precedenti la prima dose programmata di romiplostim. E` necessaria l`interpretazione da parte del laboratorio centralizzato prima della prima dose programmata di romiplostim. `Reticolina nel midollo osseo al basale di grado 0, 1, 2 o 3 secondo la scala di classificazione di Bauermeister modificata, valutata dall`interpretazione del laboratorio centralizzato. `I soggetti devono acconsentire a sottoporsi ad una biopsia del midollo osseo programmata all`anno 1, all`anno 2, o all`anno 3 dopo la terapia con romiplostim e ad eventuali biopsie non programmate, se indicato dal punto di vista clinico `Conta piastrinica &lt; 50x 109/L `Pazienti di eta`&gt; 18 anni `Deve aver ricevuto almeno 1 precedente terapia per ITP (tra gli esempi di terapia per ITP rientrano corticosteroidi, IVIG, splenectomia) `Il soggetto intende rilasciare il proprio consenso informato scritto, ed e` in grado di farlo
    E.4Principal exclusion criteria
    `Baseline bone marrow biopsy positive for collagen fibrosis `Any known history of or currently active bone marrow stem cell disorder, hematological malignancy, myeloproliferative disorder, or myelodysplastic syndrome `Any current active malignancy `Any prior exposure to cytostatic chemotherapy or radiotherapy for malignancy `Subject has undergone pacemaker placement, cardiac ablation of arrhythmia, and/or any current treatment with Vaughan Williams Class IA - IC and Class III agents `Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), or thrombopoietin receptor agonists (ie romiplostim or eltrombopag) `Subject has a known hypersensitivity to any recombinant E coli-derived product `Subject is currently enrolled in or has not yet completed (at least 4 weeks since ending) other investigational device or drug trial(s) or subject is receiving other investigational agent(s) `Other investigational procedures are excluded `Subject of child-bearing potential is evidently pregnant (eg, positive pregnancy test) or is breast feeding `Subject is not using adequate contraceptive precautions `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
    `Biopsia del midollo osseo al basale positiva per fibrosi collagenica `Disordini delle cellule staminali del midollo osseo, tumori ematologici maligni, disordini mieloproliferativi, o sindrome mielodisplastica pregressi o in corso `Tumori maligni di qualsiasi tipo in corso `Qualsiasi esposizione precedente a chemioterapia citostatica o a radioterapia per tumori maligni `Al soggetto e` stato impiantato un pacemaker, e` stato sottoposto ad ablazione di un aritmia cardiaca, e/o e` al momento sottoposto a trattamento con agenti di classe IA - IC e classe secondo classificazione di II Vaughan Williams `Il soggetto ha partecipato a studi di valutazione di PEG-rHuMGDF, trombopoietina ricombinante umana (rHuTPO), o agonisti del recettore della trombopoietina (romiplostim o eltrombopag) `Il soggetto presenta nota ipersensibilita` ai prodotti derivati da E coli ricombinante `Il soggetto e` al momento arruolato o non ha ancora completato (almeno 4 settimane dalla fine) uno o piu` trials su altri dispositivi o farmaci sperimentali, oppure il soggetto sta ricevendo uno o piu` agenti sperimentali `Sono escluse altre procedure sperimentali `Il soggetto potenzialmente in grado di avere figli e` in accertato stato di gravidanza (test di gravidanza positivo) o sta allattando al seno `Il soggetto non sta utilizzando delle misure contraccettive adeguate `Il soggetto presenta disturbi di qualsiasi tipo che compromettano la sua capacita` di rilasciare il proprio consenso informato scritto, e/o non e` in grado di seguire le procedure dello studio
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the incidence of collagen fibrosis as evidenced by trichrome staining at Years 1, 2, or 3 after initial romiplostim exposure using the modified Bauermeister grading scale.
    l`endpoint primario e` l`incidenza di fibrosi collagenica, evidenziata mediante colorazione tricromica, agli anni 1, 2, o 3 dopo esposizione iniziale a romiplostim usando la scala di classificazione Bauermeister modificata.
    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 No
    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 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 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) 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 trial3
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    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
    I soggetti saranno sottoposti aad una visita di Fine Studio 4 settimane dopo l'interruzione del trattamento con romiplostim.
    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 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.1.3Elderly (>=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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2009-09-16. Yes
    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 state21
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 150
    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
    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 Decision2009-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-01-09
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