Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43846   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-003075-11
    Sponsor's Protocol Code Number:9HB01EXT
    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:2011-12-27
    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 number2011-003075-11
    A.3Full title of the trial
    An Open-Label, Multicenter Evaluation of the Long-Term Safety and
    Efficacy of Recombinant, Human Coagulation Factor IX Fusion Protein
    (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in
    Previously Treated Subjects With Hemophilia B.
    Valutazione in aperto e multicentrica della sicurezza e dell'™efficacia della proteina di fusione ricombinante costituita dal fattore IX connesso al dominio Fc (rFIXFc) nella prevenzione e nel trattamento di episodi emorragici in soggetti affetti da emofilia B gia' sottoposti a trattamento.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study involving people with severe haemophilia B to look at
    how safe an experimental replacement factor IX protein (known as
    rFIXFc) is to take and how well it works to prevent and stop bleeds.
    Studio clinico che coinvolge le persone con emofilia B grave per verificare la sicurezza del fattore proteico sperimentale sostitutivo IX (noto come
    rFIXFc)e se funziona bene per prevenire e fermare il sanguinamento.
    A.4.1Sponsor's protocol code number9HB01EXT
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/123/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBIOGEN IDEC RESEARCH LTD
    B.1.3.4CountryUnited Kingdom
    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 supportBiogen Idec
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBIRL
    B.5.2Functional name of contact pointND
    B.5.3 Address:
    B.5.3.1Street AddressBiogen Idec Research Limited, Innovation House
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone numberND
    B.5.5Fax numberND
    B.5.6E-mailcta.submissions@biogenidec.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/453
    D.3 Description of the IMP
    D.3.1Product namerFIXFc
    D.3.2Product code rFIXFc
    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.3.9.2Current sponsor codeFIXFc
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3000
    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.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/07/453
    D.3 Description of the IMP
    D.3.1Product namerFIXFc
    D.3.2Product code rFIXFc
    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.3.9.2Current sponsor codeFIXFc
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    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 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.IMP: 3
    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/3/07/453
    D.3 Description of the IMP
    D.3.1Product namerFIXFc
    D.3.2Product code rFIXFc
    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.3.9.2Current sponsor codeFIXFc
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    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 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
    The medical condition to be investigated is Hemophilia B, or Christmas disease. Hemophilia B is a deficiency in the clotting FIX and is a recessively inherited coagulation disorder due to an X-chromosome mutation carried by females and expressed mainly by males, affecting approximately 80,000 people worldwide.
    La condizione medica da analizzare è l'emofilia B o malattia di Christmas. L'emofilia B è una carenza nel FIX della coagulazione ed è un disordine ereditario recessivo della coagulazione dovuto ad una mutazione sul cromosoma X portata dalle donne ed espressa principalmente negli uomini, e colpisce circa 80.000 persone in tutto il mondo.
    E.1.1.1Medical condition in easily understood language
    Hemophilia B is a genetic disorder that impair the body's ability to control blood clotting or coagulation, which is used to stop bleeding when a blood vessel is broken.
    L'emofilia B è una malattia genetica che compromette la capacità dell'organismo di controllare la coagulazione,utilizzata per arrestare il sanguinamento quando un vaso sanguigno è rotto.
    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 10053754
    E.1.2Term Hemophilia B without inhibitors
    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
    The primary objective of the study is to evaluate the long-term safety of rFIXFc in subjects with hemophilia B.
    L'obiettivo primario dello studio è quello di valutare la sicurezza a lungo termine di rFIXFc in soggetti affetti da emofilia di tipo B.
    E.2.2Secondary objectives of the trial
    Secondary objectives of this study in this study population are to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes.
    L'obiettivo secondario di questo studio è quello di valutare l'efficacia di rFIXFc nella prevenzione e nel trattamento degli episodi emorragici in questa popolazione di studio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of signing the informed consent at the final study visit of the previous study: The eligibility assessment must be documented. 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. Parental or guardian consent is required for subjects who are less than 18 years of age or unable to give consent, or as applicable per local laws. Subjects who are less than 18 years of age may provide assent in addition to the parental/guardian consent, if appropriate. 2. Subjects who have completed the studies 998HB102, 9HB02PED, or future studies with rFIXFc.
    Per essere ammessi a partecipare a questo studio, i candidati devono soddisfare i seguenti criteri di elegibilità al momento della firma del consenso informato alla visita finale dello studio precedente: La valutazione di elegibilità deve essere documentata. 1. Capacità di comprendere lo scopo e i rischi dello studio e fornire il consenso informato firmato e datato e l'autorizzazione a utilizzare le informazioni sanitarie protette (PHI) in conformità con la legislazione nazionale e locale sul tema della privacy. Il consenso dei genitori o del tutore è richiesto per i soggetti che hanno meno di 18 anni di età o incapaci di dare il consenso, o come applicabile per le leggi locali. Soggetti che hanno meno di 18 anni di età possono fornire assenso in aggiunta al consenso dei genitori / tutore, se appropriato. 2. I soggetti che hanno completato gli studi 998HB102, 9HB02PED, o studi futuri con rFIXFc.
    E.4Principal exclusion criteria
    Candidates will be excluded from study entry if any of the following exclusion criteria exist at the time of signing the informed consent/final study visit of the previous rFIXFc study: 1. Confirmed positive high-titer inhibitor test (≥5.00 BU/mL) 2. Medical or other reasons that, in the opinion of the Investigator make the subject unsuitable for enrollment.
    I candidati saranno esclusi dalla partecipazione allo studio se uno qualsiasi dei seguenti criteri di firma del consenso informato o alla visita di fine studio dello studio precedente con rFIXFc: 1. Test di inibizione con confermato titolo alto e positivo(&gt;= 5.00 BU/ml) 2. Motivi di salute o altro che, a giudizio dello Sperimentatore rendano il soggetto inadatto per l'arruolamento.
    E.5 End points
    E.5.1Primary end point(s)
    The frequency of inhibitor development
    La frequenza dello sviluppo dell'inibizione.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 6 months or if inhibitor development is suspected at any time during the study (for example, the expected plasma FIX activity levels are not attained, or if bleeding is not controlled as expected following dosing), inhibitor testing will be performed by the central laboratory.
    Ogni 6 mesi o, se c'è il sospetto di sviluppo di inibizione in qualsiasi momento durante lo studio (per esempio, se i livelli attesi di attività plasmatica FIX non sono raggiunti, o se l'emorragia non è controllata come previsto dopo la somministrazione), il test di inibizione sarà eseguito dal laboratorio centrale.
    E.5.2Secondary end point(s)
    Secondary Endpoints
    •The number of annualized bleeding episodes (spontaneous and traumatic) per subject.
    •The number of annualized spontaneous joint bleeding episodes per subject.
    •The total number of days of exposure per subject per year.
    •The mean dose of rFIXFc per kg per subject per year pertreatment regimen.
    •Physician's global assessment of response to treatment using a 4- point scale.
    •Subject's/caregiver's assessment of response to treatment using a 4-point scale.
    •The incidence of AEs and SAEs Surgery Endpoints
    •Investigator/Surgeon assessment of hemostatic response to surgery using the 4-point bleeding response scale.
    •Number of injections and dose per injection to maintain hemostasis during the surgical period.
    •Estimated blood loss (mL) during surgery and post-operative period.
    •Number and type of blood product units transfused during surgery.
    Patient-Reported Outcomes Endpoints. The following patient-reported outcomes will be assessed. The Investigator will administer the age-appropriate questionnaire at the appropriate visits. Quality of Life questionnaires: • Haem-A-QoL • Haemo-QoL • Hemo-Sat-P (all parents/guardians of subjects less than 18 years of age) • CHO-KLAT (for children previously enrolled in study 9 HB02PED who are less than 18 years of age) • CHO-KLAT-Proxy (for parents/guardians of children previously enrolled in study 9HB02PED and who are less than 18 years of age) • EQ-5D Y • EQ-5D-3L Health outcomes related to hemophilia will include: • Number of hospitalizations excluding planned hospitalizations, elective surgery, and emergent surgery • Number of emergency room visits • Number of physician visits excluding study visits • Number of hospitalization days • Number of days off work, school, or day care • Number of days off work for the parent or caregiver
    Secondario:
    •Il numero di episodi emorragici in un anno (spontanei e traumatici) per soggetto
    •Il numero di episodi emorragici articolari spontanei in un anno per soggetto
    •Il numero totale di giorni di esposizione annua per soggetto
    •La dose media annua di rFIXFc per kg per soggetto per ogni regime di trattamento
    •Valutazione globale del medico sulla risposta al trattamento utilizzando una scala a 4 punti
    •Valutazione del soggetto/terapeuta sulla risposta al trattamento utilizzando una scala a 4 punti
    •L'incidenza degli eventi avversi (EA) e degli eventi avversi gravi (EAG)
    Endpoint chirurgici:
    •Valutazione dello sperimentatore/chirurgo sulla risposta emostatica all'intervento chirurgico utilizzando una scala a 4 punti sulla risposta relativa alle emorragie
    •Numero di iniezioni e dosi per iniezione per mantenere l'emostasi durante il periodo chirurgico
    •Perdita di sangue stimata (ml) durante l'intervento chirurgico e nel periodo post-operatorio
    •Numero e tipo di unità di prodotto ematico trasfuso durante l'intervento chirurgico
    Risultati endpoint riferiti dal paziente
    Saranno valutati i seguenti risultati riferiti dal paziente. Lo Sperimentatore sottoporrà un questionario appropriato all'età alla visita appropriata.
    Misurazioni sulla qualità di vita:
    •Haem-A-QoL
    •Haemo-QoL
    •Hemo-Sat-P (questionario di soddisfazione dei genitori per tutti i genitori/tutori di soggetti di età inferiore ai 18 anni)
    •CHO-KLAT (per bambini precedentemente arruolati allo studio 9HB02PED di età inferiore ai 18 anni).
    •CHO-KLAT-Proxy(per genitori/tutori dei bambini precedentemente arruolati nello studio 9HB02PED)
    •EQ-5D-Y
    •EQ-5D-3L
    Outcome sulla salute correlati all'emofilia, comprendenti:
    •Numero di ricoveri in ospedale, esclusi i ricoveri pianificati, gli interventi chirurgici di elezione e gli interventi chirurgici di emergenza
    •Numero di visite in sede di emergenza
    •Numero di visite dal medico, escluse le visite dello studio
    •Numero di giorni di ricovero in ospedale
    •Numero di giorni di assenza dal lavoro o da scuola/scuola dell'infanzia/dall'asilo
    •Numero di giorni di assenza dal lavoro del genitore/tutore
    E.5.2.1Timepoint(s) of evaluation of this end point
    Per tutto il periodo di trattamento. Gli end-point del sottogruppo chirurgia sono tutti raccolti al momento della chirurgia
    Through-out treatment period. End-points for surgery subgroup are all collected at time of surgery
    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 Yes
    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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    China
    Hong Kong
    India
    Japan
    Russian Federation
    South Africa
    United States
    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 years4
    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 years4
    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: 32
    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: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 22
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 No
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 37
    F.4.2.2In the whole clinical trial 120
    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)
    Subjects will continue in the study until rFIXFc is commercially available in their country.
    I pazienti continueranno lo studio fino a quando rFIXFc sarà commercialmente disponibile nel proprio paese.
    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 Decision2012-03-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 19 13:15:01 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA