BAY79-4980 Compared to rFVIII-FS in Previously Treated Patients With Severe Hemophilia A
NCT ID: NCT00623727
Last Updated: 2013-07-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
143 participants
INTERVENTIONAL
2008-06-30
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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))
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
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)
rFVIII-FS/WFI (BAY14-2222)
25 IU/kg body weight intravenous 3x/week for 52 weeks
Interventions
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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
rFVIII-FS/WFI (BAY14-2222)
25 IU/kg body weight intravenous 3x/week for 52 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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
12 Years
70 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Bayer HealthCare Pharmaceuticals Inc.
Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Birmingham, , United Kingdom
Orange, California, United States
Sacramento, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
New Orleans, Louisiana, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
East Lansing, Michigan, United States
Rochester, Minnesota, United States
Kansas City, Missouri, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
Buffalo, New York, United States
Rochester, New York, United States
Winston-Salem, North Carolina, United States
Cincinnati, Ohio, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Houston, Texas, United States
Milwaukee, Wisconsin, United States
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Rosario, Santa Fe Province, Argentina
Perth, Western Australia, Australia
Vienna, Vienna, Austria
Graz, , Austria
Bruxelles - Brussel, , Belgium
Bruxelles - Brussel, , Belgium
Leuven, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Halifax, Nova Scotia, Canada
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Santiago, , Chile
Zagreb, , Croatia
Århus N, , Denmark
Tallinn, , Estonia
Besançon, , France
Le Kremlin-Bicêtre, , France
Lyon, , France
Marseille, , France
Montpellier, , France
Paris, , France
Paris, , France
Rennes, , France
Strasbourg, , France
Bonn, North Rhine-Westphalia, Germany
Münster, North Rhine-Westphalia, Germany
Berlin, State of Berlin, Germany
Tel Litwinsky, , Israel
Catania, , Italy
Florence, , Italy
Milan, , Italy
Napoli, , Italy
Napoli, , Italy
Torino, , Italy
Klaipėda, , Lithuania
Vilnius, , Lithuania
Groningen, , Netherlands
Nijmegen, , Netherlands
Utrecht, , Netherlands
Auckland, , New Zealand
Christchurch, , New Zealand
Oslo, , Norway
Gdansk, , Poland
Krakow, , Poland
Lodz, , Poland
Poznan, , Poland
Warsaw, , Poland
Timișoara, Timiș County, Romania
Brasov, , Romania
Bucharest, , Romania
Johannesburg, Gauteng, South Africa
Seville, Andalusia, Spain
Barcelona, Barcelona, Spain
Madrid, Madrid, Spain
Oviedo, Principality of Asturias, Spain
Santa Cruz de Tenerife, Santa Cruz de Tenerife, Spain
Valencia, Valencia, Spain
Bern, , Switzerland
Changhua, , Taiwan
Taipei, , Taiwan
Taipei, , Taiwan
Adana, , Turkey (Türkiye)
Antalya, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Cambridge, Cambridgeshire, United Kingdom
London, London, United Kingdom
Manchester, Manchester, United Kingdom
Cardiff, South Glamorgan, United Kingdom
Sheffield, South Yorkshire, United Kingdom
Countries
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References
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Di Minno G, Cerbone AM, Coppola A, Cimino E, Di Capua M, Pamparana F, Tufano A, Di Minno MN. Longer-acting factor VIII to overcome limitations in haemophilia management: the PEGylated liposomes formulation issue. Haemophilia. 2010 Jan;16 Suppl 1:2-6. doi: 10.1111/j.1365-2516.2009.02155.x.
Powell J, Martinowitz U, Windyga J, Di Minno G, Hellmann A, Pabinger I, Maas Enriquez M, Schwartz L, Ingerslev J; LipLong Study Investigators. Efficacy and safety of prophylaxis with once-weekly BAY 79-4980 compared with thrice-weekly rFVIII-FS in haemophilia A patients. A randomised, active-controlled, double-blind study. Thromb Haemost. 2012 Nov;108(5):913-22. doi: 10.1160/TH12-03-0188. Epub 2012 Sep 26.
Other Identifiers
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2007-003718-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12781
Identifier Type: -
Identifier Source: org_study_id
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