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    Summary
    EudraCT Number:2011-001144-30
    Sponsor's Protocol Code Number:NN7088-3860
    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:2012-08-02
    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 number2011-001144-30
    A.3Full title of the trial
    Efficacy and Safety of NNC 0129-0000-1003 (N8-GP) during Surgical Procedures in Patients with Haemophilia A
    Efficacia e sicurezza di NNC 0129-0000-1003 nel corso di interventi chirurgici in pazienti affetti da emofilia A
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of NNC 0129-0000-1003 (N8-GP) during Surgical Procedures in Patients with Haemophilia A
    Efficacia e sicurezza di NNC 0129-0000-1003 nel corso di interventi chirurgici in pazienti affetti da emofilia A
    A.3.2Name or abbreviated title of the trial where available
    Pathfinder™ 3
    Pathfinder™ 3
    A.4.1Sponsor's protocol code numberNN7088-3860
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1119-7326
    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 SponsorNOVO NORDISK
    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 supportNOVO NORDISK S.p.A.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovo Nordisk A/S
    B.5.2Functional name of contact pointGlobal Clinical Registry (GCR.1452)
    B.5.3 Address:
    B.5.3.1Street AddressVandtaarnsvej 114, VTB
    B.5.3.2Town/ citySoeborg
    B.5.3.3Post codeDK-2860
    B.5.3.4CountryDenmark
    B.5.4Telephone numberN/A
    B.5.5Fax numberN/A
    B.5.6E-mailclinicaltrials@novonordisk.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 nameN8-GP rFVIII
    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.3.9.1CAS number 1309086-46-1
    D.3.9.2Current sponsor codeNNC129-1003
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2000
    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
    Haemophilia A
    Emofilia di tipo A
    E.1.1.1Medical condition in easily understood language
    Bleeding disorder type A
    Disordine della coagulazione a carico del fattore VIII
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10018937
    E.1.2Term Haemophilia A
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10010331
    E.1.2Term Congenital, familial and genetic disorders
    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
    To evaluate the haemostatic effect of N8-GP during surgical procedures
    in patients with
    haemophilia A
    Valutare l’effetto emostatico di N8-GP nel corso delle operazioni chirurgiche in pazienti affetti da emofilia A
    E.2.2Secondary objectives of the trial
    - To evaluate the general safety including immunogenicity of N8-GP
    when used for prevention and treatment of bleeding throughout the
    surgical period
    - To evaluate the haemostatic effect of N8-GP during the post-operative
    period
    - To evaluate health economic resource use (hospitalisation days) due to
    surgery
    -Valutare la sicurezza generale,inclusa l’immunogenicità,di N8-GP usato nella prevenzione e il trattamento dei sanguinamenti nel corso dell’intero periodo chirurgico
    -Valutare l’effetto emostatico di N8-GP durante il periodo post-operatorio
    -Valutare l’uso delle risorse di economia sanitaria (HE) (giorni di ricovero) correlate all’intervento chirurgico
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Informed consent obtained before any trial-related activities. (Trialrelated
    activities are any procedure that would not have been performed
    during normal management of the subject.)
    - Ongoing participation in the pathfinderTM 2 (NN7088-3859) or the
    pathfinderTM 4 (NN7088-3861) trial and having received ≥5 doses of
    N8-GP
    - Undergoing major surgery (refer to Section 5.3.1 for definition)
    requiring daily monitoring of FVIII:C and wound status for ≥3 days
    - The patient and/or Legally Acceptable Representative (LAR) is capable
    of assessing a bleeding episode, keeping an eDiary, capable of home
    treatment of bleeding episodes and otherwise capable of following the
    trial procedures
    - Consenso informato ottenuto prima dell’inizio di qualsiasi attività connessa alla sperimentazione. (Le attività relative alla sperimentazione sono tutte quelle procedure che non sarebbero state portate avanti durante la normale gestione del paziente.)
    - Partecipazione continuativa alla sperimentazione pathfinderTM 2 (NN7088-3859) o pathfinderTM 4 (NN7088-3861) e aver ricevuto ≥5 dosi di N8-GP
    - Chirurgia maggiore programmata (riferirsi alla sezione 5.3.1 del protocollo per la definizione) che richieda monitoraggio giornaliero di FVIII:C e dello stato della ferita per ≥3 giorni
    - Il paziente e/o il rappresentante legalmente autorizzato (LAR, Legally Acceptable Representative) sono in grado di valutare un episodio di sanguinamento, tenere un diario elettronico, eseguire il trattamento a casa degli episodi di sanguinamento e altrimenti in grado di seguire le procedure della sperimentazione
    E.4Principal exclusion criteria
    - Known or suspected hypersensitivity to trial product including allergy
    to hamster protein or related products
    - Previous withdrawal from the pathfinderTM 2 (NN7088-3859) or the
    pathfinderTM 4 (NN7088-3861) trial after administration of trial product,
    except interruption due to inclusion in this pathfinderTM 3 trial
    (NN7088-3860)
    - The receipt of any investigational medicinal product (except N8-GP)
    within 30 days prior to enrolment into the trial. (For Brazil, only:
    Participation in a previous clinical trial within one year prior to screening
    for this trial (Visit 1), unless there is a direct benefit to the research
    subject, at the Investigator's discretion)
    - FVIII inhibitors ≥ 0.6 BU/mL at screening (refer to Section 8.1.1)
    - Previous arterial thrombotic events (e.g. myocardial infarction and
    intracranial thrombosis) or previous deep venous thrombosis or
    pulmonary embolism (as defined by available medical records)
    - Immune modulating or chemotherapeutic medication
    - Any disease (liver, kidney, inflammatory and mental disorders
    included) or condition which, according to the Investigator's judgement,
    could imply a potential hazard to the patient, interfere with trial
    participation or trial outcome
    - Unwillingness, language or other barriers precluding adequate
    understanding and/or cooperation
    - Ipersensibilità nota o sospetta al prodotto sperimentale, compresa allergia a proteine prodotte in criceto o a prodotti ad esso correlati
    - Precedente ritiro dalla sperimentazione pathfinderTM 2 (NN7088-3859) o pathfinderTM 4 (NN7088-3861) dopo la somministrazione del prodotto sperimentale, ad eccezione di interruzione dovuta a inclusione nella presente sperimentazione pathfinderTM 3 (NN7088-3860)
    - Trattamento con qualsiasi altro prodotto sperimentale, eccetto N8-GP, entro gli ultimi 30 giorni prima dell’arruolamento alla presente sperimentazione.
    - Inibitori di FVIII ≥ 0,6 BU/mL allo screening
    - Eventi trombotici arteriosi precedenti (ad esempio infarto del miocardio e trombosi intracranica) o episodi passati di trombosi venosa profonda o embolia polmonare (documentate nelle cartelle cliniche disponibili)
    -Trattamento con immunomodulatori o chemioterapici
    - Qualsiasi disturbo o condizione che, a giudizio dello sperimentatore, potrebbero implicare un potenziale pericolo per il paziente, interferire con la sua partecipazione o con il risultato dello studio
    - Indisponibilità, linguaggio o altre barriere che impediscano adeguata comprensione e/o cooperazione
    E.5 End points
    E.5.1Primary end point(s)
    Haemostatic effect during surgery evaluated by the four-point scale,
    assessed by the Investigator/surgeon at the day of surgery
    - Four-point response scale: excellent, good, moderate or none
    • Effetto emostatico durante l’intervento chirurgico valutato su una scala a quattro punti di verificato dallo sperimentatore /chirurgo nel giorno dell’intervento chirurgico
    -Scala per il responso suddivisa in quattro punti: eccellente, buono, moderato o nessuno
    E.5.1.1Timepoint(s) of evaluation of this end point
    During surgery
    Durante l'intervento chirurgico
    E.5.2Secondary end point(s)
    - Average consumption of N8-GP during surgery
    - Haemostatic effect of N8-GP during the post-operative period Days 1-6
    and 7-14
    - Average consumption of N8-GP during the post-operative period Days
    1-6
    - Incidence rate of inhibitors against factor VIII (FVIII) (≥0.6 BU/mL)
    Consumo medio di N8-GP durante l’intervento chirurgico
    Effetto emostatico di N8-GP durante il periodo post-operatorio dal giorno 1 al giorno 6
    Consumo medio di N8-GP durante il periodo post-operatorio dal giorno 1 al giorno 6
    Tasso d’incidenza di formazione degli inibitori contro FVIII (≥0,6 BU/ml)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The endpoints will be analysed based on all available information until
    End of Trial (EOT) Visit and up to approximately 5 weeks for each
    patient.
    Questi endpoints saranno analizzati basandosi su tutte le informazioni disponibili fino alla vista di fine studio e fino approssimativamente a 5 settimane per ogni paziente
    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 No
    E.8.1.2Open No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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
    Croatia
    Japan
    Korea, Republic of
    Malaysia
    Russian Federation
    Taiwan
    Turkey
    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 months17
    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 months17
    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: 2
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 2
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 16
    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 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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 9
    F.4.2.2In the whole clinical trial 18
    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)
    N/A
    N/A
    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 Opinion2012-03-20
    P. End of Trial
    P.End of Trial StatusCompleted
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