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BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A

8. juli 2013 opdateret af: Bayer

Randomized, Active-controlled, Double-blind, Parallel Design Study to Evaluate the Efficacy and Safety of a Once-a-week Prophylaxis Treatment With BAY79-4980 Compared to Three Times-per-week Prophylaxis With rFVIII-FS in Previously Treated Patients With Severe Hemophilia A

A study to assess treatment with a new formulation of recombinant factor VIII reconstituted with liposomes (BAY79-4980) to evaluate whether a once-a-week treatment is safe and can prevent bleeds in subjects with severe haemophilia A.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

143

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
    • Ciudad Auton. de Buenos Aires
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1221ADC
      • Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1425AUM
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000CKF
  • Australien
    • Western Australia
      • Perth, Western Australia, Australien, 6000
  • Belgien
      • Bruxelles - Brussel, Belgien, 1200
      • Bruxelles - Brussel, Belgien, 1020
      • Leuven, Belgien, 3000
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
      • Edmonton, Alberta, Canada, T6G 2C8
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
    • Ontario
      • Hamilton, Ontario, Canada, L8S 4J9
      • Ottawa, Ontario, Canada, K1H 8L6
      • Toronto, Ontario, Canada, M5B 1W8
      • Toronto, Ontario, Canada, M5G 1X8
  • Chile
      • Santiago, Chile
      • Santiago de Chile, Chile
  • Danmark
      • Århus N, Danmark, 8200
  • Det Forenede Kongerige
      • Birmingham, Det Forenede Kongerige, B15 2TH
      • London, Det Forenede Kongerige, SE1 7EH
      • Manchester, Det Forenede Kongerige, M13 9WL
    • Cambridgeshire
      • Cambridge, Cambridgeshire, Det Forenede Kongerige, CB2 0QQ
    • South Glamorgan
      • Cardiff, South Glamorgan, Det Forenede Kongerige, CF14 4XW
    • South Yorkshire
      • Sheffield, South Yorkshire, Det Forenede Kongerige, S10 2JF
  • Estland
      • Tallin, Estland, 13419
      • Tallinn, Estland, 13419
  • Forenede Stater
    • California
      • Orange, California, Forenede Stater, 92868
      • Sacramento, California, Forenede Stater, 95817
      • San Francisco, California, Forenede Stater, 94143-0324
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
    • Louisiana
      • New Orleans, Louisiana, Forenede Stater, 70112-2699
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48202
      • East Lansing, Michigan, Forenede Stater, 48823
    • Minnesota
      • Rochester, Minnesota, Forenede Stater, 55905
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64108-9898
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89109-2803
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87131-0001
    • New York
      • Buffalo, New York, Forenede Stater, 14215
      • Rochester, New York, Forenede Stater, 14621
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157-1009
    • Ohio
      • Cincinnati, Ohio, Forenede Stater, 45229
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104-0506
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
    • Texas
      • Houston, Texas, Forenede Stater, 77030
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53226
  • Frankrig
      • Besancon, Frankrig, 25030
      • Le Kremlin-bicetre, Frankrig, 94275
      • Lyon Cedex, Frankrig, 69437
      • Marseille, Frankrig, 13005
      • Montpellier Cedex, Frankrig, 34059
      • Paris, Frankrig, 75674
      • Paris, Frankrig, 75015
      • Rennes Cedex, Frankrig, 35033
      • Strasbourg, Frankrig, 67091
  • Holland
      • Groningen, Holland, 9713 GZ
      • Nijmegen, Holland, 6525 GA
      • Utrecht, Holland, 3508 GA
  • Israel
      • Tel Hashomer, Israel, 52621
  • Italien
      • Catania, Italien, 95124
      • Firenze, Italien, 50134
      • Milano, Italien, 20122
      • Napoli, Italien, 80131
      • Napoli, Italien, 80144
      • Torino, Italien, 10126
  • Kalkun
      • Adana, Kalkun, 01-330
      • Antalya, Kalkun, 07059
      • Izmir, Kalkun, 35-100
  • Kroatien
      • Zagreb, Kroatien, 10000
  • Litauen
      • Klaipeda, Litauen, 50809
      • Vilnius, Litauen, 08661
  • New Zealand
      • Auckland, New Zealand, 1023
      • Christchurch, New Zealand, 8001
  • Norge
      • Oslo, Norge, 0027
  • Polen
      • Gdansk, Polen, 80-952
      • Krakow, Polen, 31-501
      • Lodz, Polen, 93-510
      • Poznan, Polen, 61-833
      • Warszawa, Polen, 02-776
  • Rumænien
      • Brasov, Rumænien, 50035
      • Bucharest, Rumænien, 022328
    • Timis
      • Timisoara, Timis, Rumænien, 300011
  • Schweiz
      • Bern, Schweiz, 3010
  • Spanien
      • Barcelona, Spanien, 08035
      • Madrid, Spanien, 28046
      • Valencia, Spanien, 46026
    • Andalucía
      • Sevilla, Andalucía, Spanien, 41013
    • Asturias
      • Oviedo, Asturias, Spanien, 33006
    • Santa Cruz de Tenerife
      • Sta. Cruz de Tenerife, Santa Cruz de Tenerife, Spanien, 38009
  • Sydafrika
    • Gauteng
      • Johannesburg, Gauteng, Sydafrika, 2132
  • Taiwan
      • Changhua, Taiwan, 500
      • Taipei, Taiwan, 11217
      • Taipei, Taiwan, 10002
  • Tyskland
      • Berlin, Tyskland, 10249
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Tyskland, 53105
      • Münster, Nordrhein-Westfalen, Tyskland, 48143
  • Østrig
      • Graz, Østrig, 8036
      • Wien, Østrig, 1090

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

12 år til 70 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Han

Beskrivelse

Inclusion Criteria:

  • Males aged 12 to 70 years
  • Subjects with severe hemophilia A (< 1% factor VIII [FVIII]:C)
  • Subjects with equal or greater than 150 exposure days (EDs) with any FVIII in total
  • Subjects who have been on-demand treatment with a minimum of 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule
  • Subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records
  • Subjects with no measurable inhibitor activity
  • Subjects with no history of FVIII inhibitor antibody formation
  • Written informed consent by subject and parent / legal representative, if < 18 years

Exclusion Criteria:

  • Subjects who are receiving primary prophylaxis
  • Subjects on prophylaxis with documented requirements of > 75 IU/kg/week
  • Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand disease)
  • Subjects with abnormal renal function
  • Subjects with elevated hepatic transaminases
  • Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study
  • Subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or polyethyleneglycol (PEG)
  • Subjects who require any pre-medication for FVIII injections

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: rFVIII-FS/pegylated liposomes (BAY79-4980)
35 IU/kg body weight of BAY79-4980 1x/week plus 2 dummy injections/week (dummy = rFVIII (recombinant factor VIII)-FS (formulated with sucrose) excipient reconstituted in WFI (sterile water for injection))
Biologisk: rFVIII-FS/pegylated liposomes (BAY79-4980)
35 IU/kg body weight intravenous 1x/week for 52 weeks This arm will be stopped by 30.04.10 the subjects will be offered to change to the active comparator arm
Aktiv komparator: rFVIII-FS/WFI (BAY14-2222)
25 IU/kg body weight of rFVIII-FS 3x/week (employing 1 percent POPC (1-palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine)-alone liposome (rFVIII-FS-POPC) as blinding agent used for first weekly injection and rFVIII-FS in WFI for 2nd and 3rd injection)
Biologisk: rFVIII-FS/WFI (BAY14-2222)
25 IU/kg body weight intravenous 3x/week for 52 weeks

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Less Than 9 Total Bleeds Per Year
Tidsramme: up to one year
Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.
up to one year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants With Less Than 5 Joint Bleeds Per Year
Tidsramme: up to one year
Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.
up to one year
Number of Joint Bleeds Per Participant Per Year in Responders
Tidsramme: up to one year
Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event. Responders were the subjects with less than 9 total bleeds per year
up to one year

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Bleeds Per Year
Tidsramme: up to one year
Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event. Number of bleeds 3 weeks after the first infusion per 12 months
up to one year
Percentage of Bleeds Treated by Various Numbers of Injections
Tidsramme: up to one year
Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.
up to one year
Total rFVIII Consumption Per Year
Tidsramme: up to one year
Total number of units per kg of study medication (rFVIII) administered to participant for one year. rFVIII is recombinant factor VIII, factor VIII is functional coagulation factor
up to one year
Percentage of Participants With Less Than 9 Total Bleeds Per Year in the Open Label Extension Period
Tidsramme: 6 months after start of open label extension period
Bleeds occurring on the same day were counted as one bleeding event. Bleeds occurring within 72 hours into the same location were also counted as one bleeding event.
6 months after start of open label extension period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Bayer

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

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

1. juni 2008

Primær færdiggørelse (Faktiske)

1. april 2010

Studieafslutning (Faktiske)

1. oktober 2010

Datoer for studieregistrering

Først indsendt

9. januar 2008

Først indsendt, der opfyldte QC-kriterier

25. februar 2008

Først opslået (Skøn)

26. februar 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. juli 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2013

Sidst verificeret

1. juli 2013

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 12781
  • 2007-003718-32 (EudraCT nummer)

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 .

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