A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A
NCT ID: NCT01233258
Last Updated: 2016-11-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
80 participants
INTERVENTIONAL
2011-01-31
2012-12-31
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: rFVIII on demand first CS/EP then CS/ADJ
Participants received on-demand treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months, followed by cross-over to study drug assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months.
rFVIII (BAY81-8973) on demand
Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
Arm 2: rFVIII on demand first CS/ADJ then CS/EP
Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ for 6 months, followed by cross-over to study drug assayed by CS/EP for 6 months.
rFVIII (BAY81-8973) on demand
Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
Arm 3: rFVIII prophylaxis low-dose first CS/EP then CS/ADJ
Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII(BAY81-8973) measured by CS/ EP for 6 months then crossed over to study drug measured by CS/ADJ for 6 months.
rFVIII (BAY81-8973) prophylaxis low-dose
Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
Arm 4: rFVIII prophylaxis low-dose first CS/ADJ then CS/EP
Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) measured by CS/ADJ for 6 months then crossed over to study drug measured by CS/ EP for 6 months.
rFVIII (BAY81-8973) prophylaxis low-dose
Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
Arm 5: rFVIII prophylaxis high-dose first CS/EP then CS/ADJ
Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) measured by CS/ EP for 6 months then crossed over to study drug measured by CS/ADJ for 6 months.
rFVIII (BAY81-8973) prophylaxis high-dose
Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
Arm 6: rFVIII prophylaxis high-dose first CS/ADJ then CS/EP
Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII(BAY81-8973) measured by CS/ADJ for 6 months then crossed over to study drug measured by CS/ EP for 6 months.
rFVIII (BAY81-8973) prophylaxis high-dose
Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
Interventions
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rFVIII (BAY81-8973) on demand
Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
rFVIII (BAY81-8973) prophylaxis low-dose
Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
rFVIII (BAY81-8973) prophylaxis high-dose
Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
Eligibility Criteria
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Inclusion Criteria
* Severe hemophilia A
* History of more than 150 exposure days (ED) with clotting factor concentrates
* Currently receiving episodic treatment with FVIII; no regular prophylaxis for more than 6 consecutive months in the past 5 years
* No current Factor VIII inhibitor or history of inhibitor
* Willing to use electronic patient diary
Exclusion Criteria
* Thrombocytopenia
* Abnormal renal function
* Presence of active liver disease
* Known hypersensitivity to FVIII
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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Dayton, Ohio, United States
Houston, Texas, United States
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Corrientes, Corrientes Province, Argentina
Rosario, Santa Fe Province, Argentina
Guangzhou, Guangdong, China
Suzhou, Jiangsu, China
Beijing, , China
Shanghai, , China
Tianjin, , China
Bogotá, Bogota D.C., Colombia
Bucaramanga, Santander Department, Colombia
Olomouc, , Czechia
Hyderabad, , India
Jakarta, , Indonesia
Hiroshima, Hiroshima, Japan
Nishinomiya, Hyōgo, Japan
Kashihara, Nara, Japan
Shinjuku-ku, Tokyo, Japan
Suginami, Tokyo, Japan
Guadalajara, Jalisco, Mexico
San Luis Potosí City, San Luis Potosí, Mexico
Timișoara, Timiș County, Romania
Baia Mare, , Romania
Bucharest, , Romania
Bucharest, , Romania
Barnaul, , Russia
Khabarovsk, , Russia
Saint Petersburg, , Russia
Yekaterinburg, , Russia
Belgrade, , Serbia
Kragujevac, , Serbia
Niš, , Serbia
Novi Sad, , Serbia
Bratislava, , Slovakia
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Taichung, , Taiwan
Taipei, , Taiwan
Bangkok, Thailand, Thailand
Bangkok, Thailand, Thailand
Adana, , Turkey (Türkiye)
Antalya, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Kiev, , Ukraine
Lviv, , Ukraine
Simferopol, , Ukraine
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.
Kavakli K, Yang R, Rusen L, Beckmann H, Tseneklidou-Stoeter D, Maas Enriquez M; LEOPOLD II Study Investigators. Prophylaxis vs. on-demand treatment with BAY 81-8973, a full-length plasma protein-free recombinant factor VIII product: results from a randomized trial (LEOPOLD II). J Thromb Haemost. 2015 Mar;13(3):360-9. doi: 10.1111/jth.12828.
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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2009-012150-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
14319
Identifier Type: -
Identifier Source: org_study_id