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    Summary
    EudraCT Number:2010-020113-85
    Sponsor's Protocol Code Number:CSLCT-BIO-10-67
    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:2012-03-07
    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 number2010-020113-85
    A.3Full title of the trial
    A Multi-center, Interventional, Non-randomized, Open-label, Single-group Phase III Study to evaluate Plasma-Derived Antihemophilic Factor/von Willebrand Factor Concentrate (Biostate®) for Immune Tolerance Induction in Male Pediatric Subjects with Hemophilia A (≤2%) who have Developed High-titer Antibodies to Factor VIII (Factor VIII Inhibitors)
    Studio multicentrico, interventistico, non randomizzato, in aperto, a gruppo singolo di fase III per valutare il fattore antiemofilico derivato da plasma/ fattore di von Willebrand concentrato (Biostate®) nell`™induzione della tolleranza immunitaria in soggetti pediatrici di sesso maschile con emofilia A (2%) che abbiano sviluppato un elevato titolo anticorpale per il fattore VIII (inibitori del fattore VIII)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a clinical study to investigate how well Biostate works in treatment of male patients below the age of 12 years who have a clotting factor deficiency that is aggravated by the development of antibodies. The antibodies are directed against the clotting factor that is given for replacement therapy and usually make therapy unsuccessful. The treatment used in this study is called immune tollerance therapy.
    Questo studio clinico ha lo scopo di valutare quanto bene funziona Biostate nel trattamento di pazienti maschi sotto i 12 anni che abbiano un deficit di un fattore della coagulazione aggravato dallo sviluppo di anticorpi. Gli anticorpi sono diretti verso il fattore di coagulazione che viene dato come terapia sostitutiva e che normalmente funziona. Il trattamento usato in questo studio si chiama terapia di immunotolleranza
    A.3.2Name or abbreviated title of the trial where available
    SWIFT-ITI
    SWIFT-ITI
    A.4.1Sponsor's protocol code numberCSLCT-BIO-10-67
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/164/2009
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCSL BEHRING 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 supportCSL Behring GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationICON Plc
    B.5.2Functional name of contact pointAnna Folcioni
    B.5.3 Address:
    B.5.3.1Street AddressVia Washington, 70
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20146
    B.5.3.4CountryItaly
    B.5.4Telephone number+39 02 46571103
    B.5.5Fax number+39 80581834
    B.5.6E-mailanna.folcioni@iconplc.com
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBiostate
    D.3.2Product code NA
    D.3.4Pharmaceutical form Powder and solvent for 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 INNHuman Coagulation Factor VIII/von Willebrand factor complex
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameHuman Coagulation Factor VIII ( piu' von Willenbrand factor)
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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 Yes
    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 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBiostate
    D.3.2Product code NA
    D.3.4Pharmaceutical form Powder and solvent for 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 INNHuman Coagulation Factor VIII/von Willebrand factor complex
    D.3.9.1CAS number NA
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameHuman Coagulation Factor VIII (piu' von Willenbrand factor)
    D.3.9.4EV Substance CodeNA
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1000
    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 Yes
    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
    Male paediatric subjects with Haemophilia A who developed high titre antibodies to human coagulation Factor VIII
    Soggetti pediatrici di sesso maschile con Emofilia A che abbiano sviluppato un elevato titolo anticorpale verso il fattore umano di coagulazione VIII
    E.1.1.1Medical condition in easily understood language
    Treatment of patients with hereditary deficiency of blood coagulation factor VIII that developed neutralizing antibodies against factor VIII is investigated
    Viene valutato il trattamento in pazienti con un deficit ereditario del fattore VIII per la coagualazione che hanno sviluppato anticorpi che neutralizzano il fattore VIII.
    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 LLT
    E.1.2Classification code 10018941
    E.1.2Term Haemophilia NOS
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic 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 determine the proportion of subjects who achieve a complete response (success) following ITI treatment with Biostate.
    Determinare la proporzione di soggetti che ottiene una risposta completa (esito positivo) dopo il trattamento ITI con Biostate.
    E.2.2Secondary objectives of the trial
    To assess the safety of Biostate when administered to subjects with haemophilia A and inhibitors to FVIII in an ITI treatment regimen.
    Valutare la sicurezza di Biostate somministrato a soggetti con emofilia A e inibitori del FVIII in un regime di trattamento ITI.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male subjects diagnosed with haemophilia A (≤2% FVIII level in the absence of factor replacement, according to their medical history). 2.Age 28 days to <12 years. 3.ITI treatment can be initiated if: a.An inhibitor level of >5 and <200 BU/mL was confirmed in 2 repeated tests by the central laboratory during the screening period and no waiting period is required as judged by the investigator. b.An inhibitor level of >5 and <200 BU/mL was confirmed in 2 repeated tests by the central laboratory during the screening period and the inhibitor titre decreased from the peak titre during a waiting period (maximum 11 months) added at the discretion of the investigator. c.A subject has pre-existing inhibitors, determined no more than 11 months prior to the Screening visit, which decreased from the peak titre, and an inhibitor level of >5 and <200 BU/mL was confirmed in 2 repeated tests by the central laboratory during the screening period. A waiting period could still be added if the total duration from inhibitor diagnosis until start of ITI treatment (ie, including the screening period) does not exceed 12 months. 4.The subject and/or his legally acceptable representative understand the nature of the study and have given written informed consent to participate in the study. 5.Sufficient peripheral venous access or central venous line.
    1.Soggetti di sesso maschile a cui sia stata diagnosticata l’emofilia A (la cui anamnesi mostra un livello del FVIII ≤ 2% in assenza di fattore di sostituzione). 2.Età da 28 giorni a &lt;12 anni. 3.Il trattamento ITI può essere iniziato se: a.È stato confermato un livello dell’inibitore &gt;5 e &lt;200 BU/ml in 2 test ripetuti dal laboratorio centrale durante il periodo di screening e, secondo il parere dello sperimentatore, non è necessario un periodo di attesa. b.È stato confermato un livello dell’inibitore &gt;5 e &lt;200 BU/ml in 2 test ripetuti dal laboratorio centrale durante il periodo di screening e il titolo dell’inibitore è calato dal valore picco durante il periodo di attesa (massimo 11 mesi) aggiunto a discrezione dello sperimentatore. c.Il soggetto ha inibitori preesistenti, determinati non oltre 11 mesi prima della visita di screening, che sono calati dal picco del titolo ed è stato confermato un livello di inibitore &gt;5 e &lt;200 BU/ml in 2 test ripetuti dal laboratorio centrale durante il periodo di screening. È possibile aggiungere un altro periodo di attesa se la durata totale dalla diagnosi dell’inibitore all’inizio del trattamento ITI (ossia che include il periodo di screening) non supera i 12 mesi. 4.Il soggetto e/o il suo rappresentante legalmente riconosciuto comprendono la natura dello studio e hanno espresso consenso informato per iscritto a partecipare allo studio. 5.Sufficiente accesso venoso periferico o linea venosa centrale.
    E.4Principal exclusion criteria
    1. The subject has received ITI previously. 2. Subjects with a historical peak inhibitor titre of ≥200 BU/mL. 3. Concomitant treatment with drugs with immunosuppressive side effects (eg, systemic corticosteroids), azathioprine, cyclophosphamide, high dose immunoglobulin or the use of a protein A column or plasmapheresis and interferons. 4. High risk of cardiovascular, cerebrovascular, or other thromboembolic events (excluding catheter thrombosis) as judged by the investigator. 5.Subjects who are human immunodeficiency virus (HIV)-1 or HIV-2 positive (as reported in the medical records or determined at screening). 6.The subject has evidence or a history (within the previous 12 months) of abuse of any drug substance, licit or illicit. 7.The subject has a known or suspected hypersensitivity or has previous evidence of severe side effects to von Willebrand factor (VWF)/FVIII or FVIII concentrates or human albumin. 8.The subject has participated in a clinical study or used an investigational compound (eg, a new chemical entity not approved for clinical use) in the past 3 months, unless the study was for haemophilia A and the subject developed an inhibitor (then, a wash-out period of at least 4 weeks must be applied), or is planning to enter such a study during the study period. 9.Subjects or legal guardians/representatives with suspected inability (eg, language problems) or unwillingness to comply with study procedures. 10.The subject has an acute or chronic medical condition other than haemophilia A, which may, in the opinion of the investigator, affect the conduct of the study. 11.Mental condition rendering the subject (or the subject’s legally acceptable representative) unable to understand the nature, scope and possible consequences of the study). 12.Any condition that is likely to interfere with evaluation of the investigational medicinal product (IMP) or satisfactory conduct of the study. 13.Employee at the study site, or spouse/partner or relative of the investigator or subinvestigators.
    1.Il soggetto ha già ricevuto ITI. 2.Soggetti con picco storico del titolo dell’inibitore ≥200 BU/ml. 3.Trattamento concomitante a base di farmaci con effetti collaterali immunosoppressivi (es. corticosteroidi sistemici), azatioprina, ciclofosfamide, immunoglobuline ad alte dosi o l’uso di una colonna della proteina A o plasmaferesi e interferoni. 4.Alto rischio di eventi cardiovascolari, cerebrovascolari o altri eventi tromboembolici (esclusa la trombosi da catetere) a discrezione dello sperimentatore. 5.Soggetti positivi all’HIV-1 (virus dell’immunodeficienza umana -1) o HIV-2 (segnalato nelle cartelle cliniche o determinato allo screening). 6.Anamnesi presente o remota (nei 12 mesi precedenti) di abuso di qualsiasi sostanza farmacologica lecita o illecita da parte del soggetto. 7.Il soggetto ha ipersensibilità nota o sospetta o anamnesi remota di gravi effetti collaterali del fattore di Willebrand (VWF)/FVIII o di concentrati di FVIII o albumina umana. 8.Il soggetto ha partecipato a uno studio clinico o ha usato un composto sperimentale (es. una nuova entità chimica il cui uso clinico non è approvato) nei 3 mesi scorsi, tranne studi per l’emofilia A dove il soggetto ha sviluppato un inibitore (in tal caso deve considerarsi un periodo di wash-out di minimo 4 settimane) o a cui voglia partecipare durante il periodo di studio. 9.Soggetti o tutori/rappresentanti legali con sospetta incapacità (es. problemi di lingua) o mancata volontà di osservanza delle procedure dello studio. 10.Il soggetto ha una condizione medica acuta o cronica diversa dall’emofilia A che, a parere dello sperimentatore, può influenzare lo svolgimento dello studio. 11.Condizione mentale che rende il soggetto (o il rappresentante legalmente riconosciuto del soggetto) incapace di comprendere la natura, l’ambito d’applicazione e le possibili conseguenze dello studio. 12.Qualunque condizione che possa interferire con la valutazione del prodotto medicinale sperimentale (IMP, (investigational medicinal product) o con uno svolgimento soddisfacente dello studio. 13.Dipendente del centro di studio, oppure consorte/partner o parente dello sperimentatore o co-sperimentatori.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy endpoints: •Response to ITI treatment: complete response (success), partial response (partial success), or ITI failure. •FVIII inhibitor titre. •Time to complete response (success). •Time to inhibitor <0.6 BU/mL for the first time. Safety endpoints: •Adverse events (AEs). •Clinical laboratory testing (haematology, biochemistry). •Thrombogenic risk assessment: markers of activation of coagulation (eg, fibrin fragments, thrombin-antithrombin complex [TAT]). •Frequency and nature of bleeding events. •Catheter-related complications (eg, line infections). •Physical examination. •Vital signs (blood pressure, heart rate, and body temperature).
    Endpoint di efficacia: •Risposta al trattamento ITI: risposta completa (esito positivo), risposta parziale (esito parzialmente positivo) o esito ITI negativo. •Titolo dell’inibitore del FVIII. •Tempo alla risposta completa (esito positivo). •Tempo al titolo dell’inibitore <0,6 BU/ml per la prima volta. Endpoint di sicurezza: •Eventi avversi (EA). •Analisi cliniche di laboratorio (ematologia, biochimica). •Valutazione del rischio di trombogenesi: marcatori di attivazione della coagulazione (es. frammenti di fibrina, complesso trombina-antitrombina [TAT]). •Frequenza e natura degli episodi emorragici. •Complicazioni da catetere (es. infezioni da catetere). •Esame obiettivo. •Segni vitali (pressione sanguigna, frequenza cardiaca e temperatura corporea).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Information not available
    Informazione non disponibile
    E.5.2Secondary end point(s)
    Please see section primary endpoint(s)
    Vedi sezione endpoint primario/i
    E.5.2.1Timepoint(s) of evaluation of this end point
    Information not available
    Informazione non disponibile
    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 Yes
    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 No
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA14
    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 Yes
    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 months65
    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 months65
    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: 15
    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.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 13
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    paediatric population
    Popolazione pediatrica
    F.4 Planned number of subjects to be included
    F.4.1In the member state4
    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)
    After the study participation the patients will be treated with the current standard therapy on the discretion of their treating doctor. It is expected at the end of the study Biostate will be licensed
    Dopo la partecipazione allo studio, i pazienti saranno trattati con la terapia standard disponibile attualmente a discrezione del medico che li segue. Ci si aspetta che Biostate ottenga la licenza alla fine 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 Decision2012-05-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-20
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-03-07
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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