Trial to Evaluate the Efficacy and Safety of a New Full Length Recombinant Human FVIII for Hemophilia A
NCT ID: NCT01029340
Last Updated: 2016-11-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
74 participants
INTERVENTIONAL
2009-12-31
2013-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Arm 1: Recombinant Factor VIII (BAY81-8973) then Kogenate FS
Part A - Arm 1: Participants first received one single intravenous (IV) injection of BAY81-8973 50 IU/kg, then 1 single IV injection of Kogenate FS (BAY14-2222) 50 IU/kg with a wash-out period of at least 2-3 days in between
Recombinant Factor VIII (BAY81-8973)
Single dose of BAY81-8973 crossed over to single dose of Kogenate FS
Arm 2: Kogenate FS then Recombinant Factor VIII (BAY81-8973)
Part A - Arm 2: Participants first received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg, then 1 single IV injection of BAY81-8973 50 IU/kg with a wash-out period of at least 2-3 days in between
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Single dose of Kogenate FS crossed over to Single dose of BAY81-8973
Arm 3: Recombinant Factor VIII by CS/EP then by CS/ADJ
Part B - Arm 3: Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay/Adjusted to Label Potency for 6 months
Recombinant Factor VIII (BAY81-8973)
Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
Arm 4: Recombinant Factor VIII by CS/ADJ then by CS/EP
Part B - Arm 4:. Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted to Label Potency for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay Per European Pharmacopeia for 6 months
Recombinant Factor VIII (BAY81-8973)
Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
Arm 5: Recombinant Factor VIII by CS/EP
Part C - Arm 5: Participants received a loading dose of approximately 50 IU/kg of BAY 81-8973 before the first surgical incision followed by further treatment with BAY 81-8973 according to surgical requirements for up to 3 weeks
Recombinant Factor VIII (BAY81-8973)
Participants received a loading dose of approximately 50 IU/kg of BAY 81-8973 before the first surgical incision followed by further treatment with BAY 81-8973 according to surgical requirements for up to 3 weeks
Interventions
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Recombinant Factor VIII (BAY81-8973)
Single dose of BAY81-8973 crossed over to single dose of Kogenate FS
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Single dose of Kogenate FS crossed over to Single dose of BAY81-8973
Recombinant Factor VIII (BAY81-8973)
Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
Recombinant Factor VIII (BAY81-8973)
Participants received a loading dose of approximately 50 IU/kg of BAY 81-8973 before the first surgical incision followed by further treatment with BAY 81-8973 according to surgical requirements for up to 3 weeks
Eligibility Criteria
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Inclusion Criteria
* Severe hemophilia A defined as \< 1% FVIII:C
* \>/= 150 days of previous treatment with FVIII in lifetime
* Currently receiving on-demand or any type of prophylaxis treatment regimen with any FVIII product
* No history of or current FVIII inhibitors
Exclusion Criteria
* Low platelet count, abnormal kidney function, or liver disease
* Received treatment with immune suppressing drugs within the last 3 months prior or requires treatment during the study. (Some drugs for hepatitis C, Human immunodeficiency virus (HIV), and steroids are allowed)
* Receiving or has received other experimental drugs within 3 months prior to study entry
* Allergy to Factor VIII or hamsters or mouse protein
12 Years
65 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Orange, California, United States
Sacramento, California, United States
Tampa, Florida, United States
Boston, Massachusetts, United States
East Lansing, Michigan, United States
Kansas City, Missouri, United States
Cleveland, Ohio, United States
Bahía Blanca, Buenos Aires, Argentina
Rosario, Santa Fe Province, Argentina
Vienna, Vienna, Austria
Graz, , Austria
Zagreb, , Croatia
DK-Aarhus N, , Denmark
Frankfurt am Main, Hesse, Germany
Bonn, North Rhine-Westphalia, Germany
Mainz, Rhineland-Palatinate, Germany
Homburg, Saarland, Germany
Magdeburg, Saxony-Anhalt, Germany
Hong Kong, , Hong Kong
Bangalore, , India
Mumbai, , India
Pune, , India
Jakarta, , Indonesia
Ramat Gan, , Israel
Catanzaro, Calabria, Italy
Napoli, Campania, Italy
Napoli, Campania, Italy
Rome, Lazio, Italy
Milan, Lombardy, Italy
Vicenza, Veneto, Italy
Oslo, , Norway
Karachi, , Pakistan
Krakow, , Poland
Warsaw, , Poland
Belgrade, , Serbia
Niš, , Serbia
Novi Sad, , Serbia
Pretoria, Gauteng, South Africa
Parktown, , South Africa
A Coruña, A Coruña, Spain
Barcelona, Barcelona, Spain
Santander, Cantabria, Spain
Jaén, Jaén, Spain
Oviedo, Principality of Asturias, Spain
Valencia, Valencia, Spain
Gothenburg, , Sweden
Malmo, , Sweden
Karolinska Universitetssjukhuset i Solna
Stockholm, , Sweden
Taipei, Taipei, Taiwan
Changhua, , Taiwan
Taipei, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Adana, , Turkey (Türkiye)
Antalya, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Dundee, Dundee City, United Kingdom
Oxford, Oxfordshire, United Kingdom
Sheffield, South Yorkshire, United Kingdom
London, , United Kingdom
Countries
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References
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Kitchen S, Katterle Y, Beckmann H, Maas Enriquez M. Chromogenic assay for BAY 81-8973 potency assignment has no impact on clinical outcome or monitoring in patient samples. J Thromb Haemost. 2016 Jun;14(6):1192-9. doi: 10.1111/jth.13322. Epub 2016 May 3.
Oldenburg J, Windyga J, Hampton K, Lalezari S, Tseneklidou-Stoeter D, Beckmann H, Maas Enriquez M. Safety and efficacy of BAY 81-8973 for surgery in previously treated patients with haemophilia A: results of the LEOPOLD clinical trial programme. Haemophilia. 2016 May;22(3):349-53. doi: 10.1111/hae.12839. Epub 2016 Mar 1.
Saxena K, Lalezari S, Oldenburg J, Tseneklidou-Stoeter D, Beckmann H, Yoon M, Maas Enriquez M. Efficacy and safety of BAY 81-8973, a full-length recombinant factor VIII: results from the LEOPOLD I trial. Haemophilia. 2016 Sep;22(5):706-12. doi: 10.1111/hae.12952. Epub 2016 Jun 24.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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2009-012149-43
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12954
Identifier Type: -
Identifier Source: org_study_id