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    Summary
    EudraCT Number:2008-003960-20
    Sponsor's Protocol Code Number:NN7008-3543
    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:2009-05-21
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-003960-20
    A.3Full title of the trial
    Ensayo multicéntrico, abierto, no controlado sobre la eficacia y la seguridad de N8 en la prevención y el tratamiento a demanda de los episodios hemorrágicos en sujetos con hemofilia A previamente tratados

    Subestudio:
    Eficacia y seguridad de N8 en la prevención y el tratamiento de la hemorragia durante los procedimientos quirúrgicos en sujetos con hemofilia A

    Efficacy and Safety of N8 in Prevention and On-demand
    Treatment of Bleeding Episodes in Previously Treated
    Subjects with Haemophilia A
    Sub-Trial:
    Efficacy and Safety of N8 in Prevention and Treatment
    of Bleeding during Surgical Procedures in Subjects with
    Haemophilia A
    A.4.1Sponsor's protocol code numberNN7008-3543
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovo Nordisk A/S
    B.1.3.4CountryDenmark
    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 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
    D.3.2Product code NN7008
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNN8
    D.3.9.2Current sponsor codeNN7008
    D.3.9.3Other descriptive nameRecombinant Factor VIII
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10018937
    E.1.2Term Haemophilia A
    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 efficacy of N8 in bleeding prevention in subjects with
    haemophilia A.
    - To evaluate the efficacy of N8 in on-demand treatment of bleeding episodes in subjects with haemophilia A

    Additional Primary Objective for Part A (only)
    - To describe the steady-state PK profile of N8 in the subjects who participated in NN7008-3522, 3 months after initial dose of N8.

    Part C:
    - To evaluate the efficacy of N8 in bleeding prevention during surgical procedures in subjects
    with haemophilia A
    - To evaluate the haemostatic effect of N8 during surgical procedures and in the early postoperative period (Day 1 to Day 6) in subjects with haemophilia A
    E.2.2Secondary objectives of the trial
    - To evaluate the safety of N8 when used for prevention of bleeding episodes and on-demand treatment of bleeding episodes in subjects with haemophilia A.
    - To assess the frequency of development of inhibitors defined as clinically important inhibitors to FVIII (?0.6 BU/mL)
    - To assess and compare Patient Reported Outcomes (PROs)

    Part C:
    - To evaluate the safety of N8 when used for prevention and treatment of bleeding during surgical procedures and in the early postoperative period in subjects with haemophilia A
    - To assess the frequency of inhibitor development defined as clinically important inhibitors to FVIII when used for prevention and treatment of bleeding during surgical procedures and in the early postoperative period in subjects with haemophilia A
    - To assess and compare PRO
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Title:
    Efficacy and Safety of N8 in Prevention and Treatment of Bleeding during Surgical Procedures in Subjects with Haemophilia A

    Date: 11 Feb 2009
    Version: 6

    Objectives:
    The primary objectives are:
    - To evaluate the efficacy of N8 in bleeding prevention during surgical procedures in subjects
    with haemophilia A
    - To evaluate the haemostatic effect of N8 during surgical procedures and in the early postoperative period (Day 1 to Day 6) in subjects with haemophilia A
    E.3Principal inclusion criteria
    Part A
    1. Completion of the phase 1 PK trial NN7008-3522
    2. Informed consent obtained prior to any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
    3. Male subjects with the diagnosis of severe (baseline FVIII?1%) haemophilia A from age 12 to 56 years having a weight of 10 to 120 kg.
    4. Willing to undergo a bleeding preventive regimen of 75 exposure days
    5. Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product for measurement of recovery in relation to administration of the first dose and the PK session
    6. Documented history of at least 150 exposure days to any other FVIII products (prevention or on-demand treatment) (Please refer to section 8.6.2.3)
    7. No history of FVIII inhibitors ?0.6 BU/mL measured regularly since the first treatment of haemophilia A prior to entering the trial or the time period should cover at least 8 years (Please refer to section 8.6.2.2)
    8. No detectable inhibitors to FVIII ( ?0.6 BU/mL) (as assessed by central laboratory at the investigative site at the time of screening)
    9. Hepatitis C Virus (HCV) seronegative or if HCV seropositive, viral load <200.000 IU/mL and CD4+ lymphocyte count ? 200/µL.
    10. Lupus anticoagulant negative
    11. HIV-1 seronegative or if HIV-1 seropositive, the viral load <400.000 copies/mL and the CD4+ lymphocyte count ?200/µL.
    Part B
    1. Informed consent obtained prior to any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject).
    2.Male subjects with the diagnosis of severe (baseline FVIII?1%) haemophilia A from age 12 to 65 years having a weight of 10 to 120 kg.
    3. Willing to undergo a bleeding preventive regimen of 75 exposure days 4. Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product for measurement of recovery in relation to administration of the first dose
    5. Documented history of at least 150 exposure days to any other FVIII products (prevention or on-demand treatment) (Please refer to section 8.6.2.3)
    6. No history of FVIII inhibitors ?0.6 BU/mL measured regularly since the first treatment of haemophilia A prior to entering the trial or the time period should cover at least 8 years (Please refer to History of Inhibitors in section 8.6.2.2)
    7. No detectable inhibitors to FVIII ( ?0.6 BU/mL) (as assessed by central laboratory at the time of screening)
    8. HCV seronegative and or if HCV seropositive, viral load <200.000 IU/mL and CD4+ lymphocyte count ? 200/µL.
    9. Lupus anticoagulant negative
    10. HIV-1 seronegative or if HIV-1 seropositive, the viral load <400.000
    copies/mL and the CD4+ lymphocyte count ?200/µL.
    Part C:
    12.Scheduled to undergo major or minor surgical procedures
    13.Surgical procedure requiring at least 6 days of infusion of N8 concentrate post-operatively.
    Subjects will only participate in Part C when they have been included in either Part A or Part and have received at least one dose of trial product (N8).
    E.4Principal exclusion criteria
    1. Subjects on Immune Tolerance Treatment (ITT) regimens
    2.Pharmaceutical treatment of a mild and moderate bleeding episode within one week prior to first dose
    3. Pharmaceutical treatment of a severe bleeding episode within one week prior to first dose
    4. Known pseudo-tumours
    5. Platelet count <50,000 platelets/µL (based on medical records) at trial entry
    6. Severe current hepatic dysfunction or severe hepatic disease during the last 12 months
    7. ALAT > than 4 times of the upper limit of normal reference range (as defined by central laboratory ranges
    8. Septicaemia, e.g. febrile illness within 5 days prior to trial product administration
    9. Current dialysis therapy
    10. Creatinine levels 50% above normal level (according to central laboratory range)
    11. Congenital or acquired coagulation disorders other than haemophilia A
    12. Previous arterial thrombotic events (Myocardial Infarction and Intra Cranial Thrombosis) (as defined by medical records).
    13. Known or suspected allergy to trial product (N8) or related products
    14. Surgery within one month prior to first administration of trial product (catheter, stents, ports, and dental extractions do not count as surgeries, i.e. they will not exclude the subject)
    15. Use of Coagulation Factors: FVIII concentrates or other FVIII containing products within four days prior to first administration of trial product
    16. Use of Anticoagulants: Heparin, vitamin-K antagonists, and direct thrombin inhibitors one week prior to first administration of trial product
    17. Use of non-prescribed opiate substances
    18. Regular use of cannabis (only for subjects in Part A)
    19. Use of platelet inhibitors including NSAID one week prior to first administration of trial product
    20. The receipt of any investigational drug within 30 days prior to administration of trial product except subjects who have completed NN7008-3522
    21. Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008-3522 after administration of trial product
    22. Any disease or condition which, according to the Investigator?s judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome
    23. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints
    Total consumption of N8 (prevention and on-demand) per month and/or year
    Prevention
    - Assessment of the actual consumption of N8 (IU/kg BW/months) for prevention
    - Assessment of the average number of break-through bleeds per month reported during the preventative regimen
    On-Demand
    - Assessment of the actual consumption of N8 (IU/kg BW/bleeding episode).
    - Assessment of the haemostatic response (none, moderate, good or excellent) when haemostasis has been achieved.
    Part C:
    - Assessment of the actual consumption of N8 (IU/kg BW)
    o Time period Day 1 to Day 6
    o Time period Day 7 to return to prevention regimen
    - Assessment of haemostatic effect when haemostasis has been achieved
    - Haemoglobin level prior to surgery and after surgery
    - Amount of blood or blood product for transfusion
    - Loss of blood
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years2
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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.1.1.1In 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.1.2Adults (18-64 years) Yes
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state3
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 140
    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 Decision2009-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-09-21
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