Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015
27. juni 2017 opdateret af: Novo Nordisk A/S
Safety and Efficacy of N8 in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A
This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America.
The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients.
The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
214
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Rio de Janeiro, Brasilien, 20211-030
- Novo Nordisk Investigational Site
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Parana
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Curitiba, Parana, Brasilien, 80250-060
- Novo Nordisk Investigational Site
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Sao Paulo
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Campinas, Sao Paulo, Brasilien, 13081970
- Novo Nordisk Investigational Site
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São Paulo, Sao Paulo, Brasilien, 05403-000
- Novo Nordisk Investigational Site
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Moscow, Den Russiske Føderation, 119049
- Novo Nordisk Investigational Site
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Saint-Petersburg, Den Russiske Føderation, 191119
- Novo Nordisk Investigational Site
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London, Det Forenede Kongerige, NW3 2QG
- Novo Nordisk Investigational Site
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London, Det Forenede Kongerige, SE1 7EH
- Novo Nordisk Investigational Site
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Manchester, Det Forenede Kongerige, M13 9WL
- Novo Nordisk Investigational Site
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Arizona
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Phoenix, Arizona, Forenede Stater, 85016-7710
- Novo Nordisk Investigational Site
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California
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Long Beach, California, Forenede Stater, 90806
- Novo Nordisk Investigational Site
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Florida
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Tampa, Florida, Forenede Stater, 33607
- Novo Nordisk Investigational Site
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Georgia
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Atlanta, Georgia, Forenede Stater, 30322
- Novo Nordisk Investigational Site
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Iowa
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Iowa City, Iowa, Forenede Stater, 52242
- Novo Nordisk Investigational Site
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Novo Nordisk Investigational Site
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45229
- Novo Nordisk Investigational Site
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Dayton, Ohio, Forenede Stater, 45404
- Novo Nordisk Investigational Site
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Oregon
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Portland, Oregon, Forenede Stater, 97239
- Novo Nordisk Investigational Site
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Rhode Island
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Providence, Rhode Island, Forenede Stater, 02903
- Novo Nordisk Investigational Site
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37232-9830
- Novo Nordisk Investigational Site
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Texas
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Houston, Texas, Forenede Stater, 77030
- Novo Nordisk Investigational Site
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Washington
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Spokane, Washington, Forenede Stater, 99204
- Novo Nordisk Investigational Site
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Tel Aviv, Israel
- Novo Nordisk Investigational Site
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Tel-Hashomer, Israel, 52621
- Novo Nordisk Investigational Site
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Firenze, Italien, 50134
- Novo Nordisk Investigational Site
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Milano, Italien, 20124
- Novo Nordisk Investigational Site
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Kashihara-shi, Nara, Japan, 634 8522
- Novo Nordisk Investigational Site
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Nagoya-shi, Aichi, Japan, 466 8560
- Novo Nordisk Investigational Site
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Shimotsuke-shi, Tochigi, Japan, 329 0498
- Novo Nordisk Investigational Site
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Shinjuku-ku, Tokyo, Japan, 160 0023
- Novo Nordisk Investigational Site
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Shizuoka-shi, Shizuoka, Japan, 4208660
- Novo Nordisk Investigational Site
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Adana, Kalkun, 01130
- Novo Nordisk Investigational Site
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Antalya, Kalkun, 01010
- Novo Nordisk Investigational Site
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Bornova-IZMIR, Kalkun, 35100
- Novo Nordisk Investigational Site
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Izmit, Kalkun, 41380
- Novo Nordisk Investigational Site
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Samsun, Kalkun, 55319
- Novo Nordisk Investigational Site
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Split, Kroatien, 21 000
- Novo Nordisk Investigational Site
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Zagreb, Kroatien, 10 000
- Novo Nordisk Investigational Site
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Riga, Letland, 1006
- Novo Nordisk Investigational Site
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Vilnius, Litauen, LT-08406
- Novo Nordisk Investigational Site
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Skopje, Makedonien, Den Tidligere Jugoslaviske Republik, 1000
- Novo Nordisk Investigational Site
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Kuala Lumpur, Malaysia, 50400
- Novo Nordisk Investigational Site
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Warszawa, Polen, 00-576
- Novo Nordisk Investigational Site
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Wroclaw, Polen, 50-556
- Novo Nordisk Investigational Site
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San Juan, Puerto Rico, 00935
- Novo Nordisk Investigational Site
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Zürich, Schweiz, 8091
- Novo Nordisk Investigational Site
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Belgrade, Serbien, 11000
- Novo Nordisk Investigational Site
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Belgrade, Serbien, 11070
- Novo Nordisk Investigational Site
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Nis, Serbien, 18000
- Novo Nordisk Investigational Site
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Novi Sad, Serbien, 21000
- Novo Nordisk Investigational Site
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Madrid, Spanien, 28046
- Novo Nordisk Investigational Site
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Valencia, Spanien, 46026
- Novo Nordisk Investigational Site
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Taipei, Taiwan, 100
- Novo Nordisk Investigational Site
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Berlin, Tyskland, 10249
- Novo Nordisk Investigational Site
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Bonn, Tyskland, 53127
- Novo Nordisk Investigational Site
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Giessen, Tyskland, 35392
- Novo Nordisk Investigational Site
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Hannover, Tyskland, 30625
- Novo Nordisk Investigational Site
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
6 måneder til 70 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
- Informed Consent obtained before any trial-related activities
- Completion of trial NN7008-3543 or paediatric trial NN7008-3545 or Japanese trial NN7008-3600 or pharmacokinetic trial NN7008-3893 or NN7008-4015
Exclusion Criteria:
- Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008-3522, NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 or NN7008-4015 after administration of trial product
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Turoctocog alfa
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Den forebyggende behandling administreres intravenøst (i.v.) med specifikke intervaller enten hver anden dag eller tre gange om ugen.
Blødningsbehandling vil blive givet, hvis der skulle opstå en blødning.
Behandlingen administreres intravenøst (i.v.) under blødninger og lejlighedsvis som en forebyggende behandling (f.
før fysisk aktivitet)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL)
Tidsramme: After 90 months
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The frequency of inhibitors was calculated as number of patients with inhibitors during the trial divided by number of patients in the trial.
This endpoint was measured during the trial.
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After 90 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Frequency of Adverse Events and Serious Adverse Events
Tidsramme: After 90 months
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The number of adverse events and serious adverse events reported during the main trial and the on-demand sub-trial (during 90 months).
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After 90 months
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Annualised Bleeding Rate Reported During the Prevention Period (Only Applicable for Subjects in the Preventive Regimen)
Tidsramme: After 90 months
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The number of bleeding episodes per year reported during the prevention period (during 90 months).
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After 90 months
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Haemostatic Response to Turoctocog Alfa (None, Moderate, Good or Excellent) in Treatment of Bleeds.
Tidsramme: After 90 months
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Haemostatic response to turoctocog alfa (none, moderate, good or excellent) in treatment of bleeds using a four-point response scale: none, moderate, good or excellent.
The evaluation was done by patient, caregiver and/or investigator based on experience as follows: 1. Excellent: Abrupt pain relief and/or unequivocal improvement in objective signs of bleeding within approximately 8 hours after a single infusion 2. Good: Definite pain relief and/or improvement in signs of bleeding within approximately 8 hours after an infusion, but possibly requiring more than 1 infusion for complete resolution.
3. Moderate: Probable or slight beneficial effect within approximately 8 hours after the first infusion; usually requiring more than 1 infusion.
4. None: No improvement, or worsening of symptoms.
This endpoint is measured during the preventive and on-demand sub-trial (during 90 months).
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After 90 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Ozelo M, Misgav M, Abdul-Karim F, Lentz S, Martin-Salces M, Matytsina I, Saugstrup T, Santagostino E. Stabilization of turoctocog alfa dose administered in a preventive regimen: 3-year interim results of the guardianTM-2 extension trial. Haemophilia - Special Issue: Abstracts of the WFH 2014 World Congress, May 11-15, Melbourne, Australia; 20 (3): 1-200
- Recht M, Lentz S, Zupancic-Salek S, Matytsina I, Landorph A, Saugstrup T. Factor VIII Dosing and Preventive Efficacy in Obese Patients with Hemophilia (BMI =30 kg/m2) - a Post-Hoc Sub-Analysis of the guardian™ Trials. American Society of Hematology - 56th Annual Meeting (ASH); Country: US City: San Francisco, CA
- Ozelo M, Misgav M, Abdul Karim F, Lentz SR, Martin-Salces M, Matytsina I, Saugstrup T, Santagostino E. Long-term patterns of safety and efficacy of bleeding prophylaxis with turoctocog alfa (NovoEight((R)) ) in previously treated patients with severe haemophilia A: interim results of the guardian() 2 extension trial. Haemophilia. 2015 Sep;21(5):e436-9. doi: 10.1111/hae.12737. Epub 2015 Jun 8. No abstract available.
- Lentz SR, Cerqueira M, Janic D, Kempton C, Matytsina I, Misgav M, Oldenburg J, Ozelo M, Recht M, Rosholm A, Savic A, Suzuki T, Tiede A, Santagostino E. Interim results from a large multinational extension trial (guardian() 2) using turoctocog alfa for prophylaxis and treatment of bleeding in patients with severe haemophilia A. Haemophilia. 2016 Sep;22(5):e445-9. doi: 10.1111/hae.12990. Epub 2016 Jun 13. No abstract available.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
26. oktober 2009
Primær færdiggørelse (Faktiske)
28. juni 2016
Studieafslutning (Faktiske)
29. juni 2016
Datoer for studieregistrering
Først indsendt
21. september 2009
Først indsendt, der opfyldte QC-kriterier
24. september 2009
Først opslået (Skøn)
25. september 2009
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. juli 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. juni 2017
Sidst verificeret
1. juni 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NN7008-3568
- 2008-005945-46 (EudraCT nummer)
- U1111-1111-9377 (Anden identifikator: WHO)
- JapicCTI-101357 (Registry Identifier: JAPIC)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .