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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43935   clinical trials with a EudraCT protocol, of which   7309   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).

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    EudraCT Number:2015-005327-63
    Sponsor's Protocol Code Number:NN7088-4033
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-25
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2015-005327-63
    A.3Full title of the trial
    A multi-centre, comparative, double blind, randomised cross-over trial investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia A
    Ensayo multicéntrico, comparativo, doble ciego, aleatorizado y cruzado para investigar la farmacocinética y la seguridad de dosis única de turoctocog alfa pegol a partir del proceso pivotal y de turoctocog alfa pegol a partir del proceso comercial en pacientes con hemofilia A grave
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from two different production processes in patients with severe haemophilia A
    Ensayo clínico que investiga la farmacocinética y seguridad de una dosis única de turoctocog alfa pegol procedente de dos procesos de producción distintos en pacientes con hemofilia A grave.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberNN7088-4033
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1176-9253
    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 A/S
    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 A/S
    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 AddressNovo Allé
    B.5.3.2Town/ cityBagsværd
    B.5.3.3Post code2880
    B.5.4Telephone number+34 91 3349800
    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/3/12/995
    D.3 Description of the IMP
    D.3.1Product nameN8-GP rFVIII
    D.3.2Product code NNC129-1003
    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 INNturoctocog alfa pegol
    D.3.9.2Current sponsor codeNNC129-1003
    D.3.9.3Other descriptive nameTUROCTOCOG ALFA PEGOL
    D.3.9.4EV Substance CodeSUB31680
    D.3.10 Strength
    D.3.10.1Concentration unit IU international 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Hemofilia A
    E.1.1.1Medical condition in easily understood language
    Bleeding disorder, inherited deficiency in clotting factor VIII
    Trastorno hemorrágico congénico por deficiencia de factor VIII de coagulación
    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 19.0
    E.1.2Level LLT
    E.1.2Classification code 10018938
    E.1.2Term Haemophilia A (Factor VIII)
    E.1.2System Organ Class 100000004850
    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 and compare the single-dose pharmacokinetic of turoctocog alfa pegol from the pivotal process with turoctocog alfa pegol from the commercial process, each given as intravenous administrations of 50 U/kg to patients with severe haemophilia A
    Evaluar y comparar la farmacocinética de dosis única de turoctocog alfa pegol a partir del proceso pivotal y de turoctocog alfa pegol a partir del proceso comercial, cada uno administrado por vía intravenosa en una dosis de 50 U/kg a pacientes con hemofilia A grave
    E.2.2Secondary objectives of the trial
    To assess the safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process after single intravenous doses of 50 U/kg in patients with severe haemophilia A
    Evaluar la seguridad de turoctocog alfa pegol a partir del proceso pivotal y turoctocog alfa pegol a partir del proceso comercial tras dosis intravenosas únicas de 50 U/kg en pacientes con hemofilia A grave
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
    2. Ongoing participation in pathfinder™2 (NN7088-3859)
    3. Male, age ≥ 12 years at the time of signing informed consent (in certain countries the lower age limit will be 18 years, according to local requirements)
    1.Obtención del consentimiento informado antes de realizar ninguna actividad relacionada con el ensayo. Se consideran actividades relacionadas con el ensayo todos los procedimientos que se lleven a cabo como parte del ensayo, incluidas las actividades para determinar la idoneidad para participar en él.
    2.Participación actual en pathfinder™2
    3.Varones ≥ 12 años de edad en el momento de la firma del consentimiento informado (en algunos países, el límite de edad inferior será de 18 años, de conformidad con las normas locales)
    E.4Principal exclusion criteria
    1. FVIII inhibitors (≥0.6 BU) at last visit in pathfinder™2 prior to entry in pathfinder™7
    2. Planned surgery during the trial
    3. Major surgery performed within 4 weeks prior to screening
    4. Previous participation in this trial. Participation is defined as signed informed consent
    5. Any disorder, except for conditions associated with haemophilia A, which in the investigator’s opinion might jeopardise patient’s safety or compliance with the protocol
    1.Inhibidores del FVIII (≥ 0,6 UB) en la última visita de pathfinder™2 antes de incorporarse a pathfinder™7
    2.Intervención quirúrgica programada durante el ensayo
    3.Intervención de cirugía mayor realizada en las 4 semanas previas a la selección
    4.Participación previa en este ensayo. La participación se define como la firma del consentimiento informado.
    5.Cualquier trastorno, salvo las afecciones asociadas a la hemofilia A, que en opinión del investigador pueda poner en peligro la seguridad del paciente o el cumplimiento del protocolo
    6.Participación en cualquier ensayo clínico (excepto pathfinder™2) de un producto en investigación aprobado o no aprobado
    E.5 End points
    E.5.1Primary end point(s)
    Area under the FVIII activity-time curve - dose normalised to 50 U/kg (AUC0-96h, norm)
    Área bajo la curva de actividad del FVIII-tiempo entre 0 y 96 horas después de la inyección - con normalización de la dosis a 50 U/kg (AUC0-96 h, norm)
    E.5.1.1Timepoint(s) of evaluation of this end point
    From 0 to 96 h post injection
    De 0 a 96 horas después de la inyección.
    E.5.2Secondary end point(s)
    The key secondary pharmacokinetic endpoints are for the first and second pharmacokinetic periods, separately.

    The following pharmacokinetic endpoints will be derived based on plasma FVIII activity measured:

    1. FVIII activity 30 min post administration - dose normalised to 50 U/kg
    2. Area under the FVIII activity-time curve from 0 to infinity
    3. Clearance
    4. Incremental recovery
    5. Terminal half-life

    All blood samples for the pharmacokinetic assessment will be analysed using both chromogenic and one-stage clotting assays.
    Los criterios de valoración farmacocinéticos secundarios más importantes son para los periodos farmacocinéticos primero y segundo por separado.
    Se obtendrán los siguientes criterios de valoración farmacocinéticos basándose en la actividad plasmática del FVIII, medida desde el momento de la administración del producto del ensayo hasta 96 horas después de la dosis:
    •Actividad del FVIII 30 minutos después de la administración - con normalización de la dosis a 50 U/kg
    •Área bajo la curva de actividad del FVIII-tiempo entre 0 e infinito
    •Recuperación incremental
    •Semivida terminal
    Todas las muestras de sangre para la evaluación farmacocinética se analizarán mediante análisis de coagulación monofásico y cromogénico.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From time of trial product administration to 96 hours post-dose
    Desde el momento de la administración del producto en investigación hasta 96 horas después de la inyección.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Comparison between N8-GP from the pivotal and commercial process
    Comparación entre el N8-GP obtenido mediante el proceso pivotal y el N8-GP obtenido mediante el proceso comercial
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E. description
    N8-GP obtenido a partir de otro proceso de producción
    N8-GP from another production process
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    European Union
    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
    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 months6
    E.8.9.1In the Member State concerned days7
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days7
    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: 1
    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. of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 8
    F.4.2.2In the whole clinical trial 22
    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)
    Patients will return to pathfinder™2 (NN7088-3859) upon completion of pathfinder™7 (NN7088-4033).
    Los pacientes volverán al pathfinder™2 (NN7088-3859) una vez completen el pathfinder™7 (NN7088-4033).
    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 Decision2016-08-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-07
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