Trial to Evaluate the Effect of Secondary Prophylaxis With rFVIII Therapy in Severe Hemophilia A Adult and/or Adolescent Subjects Compared to That of Episodic Treatment
NCT ID: NCT00623480
Last Updated: 2014-11-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
84 participants
INTERVENTIONAL
2008-03-31
2013-11-30
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
NONE
Study Groups
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Recombinant Factor VIII prophylaxis treatment
Participants received 25 IU/kg of Recombinant Factor VIII (Kogenate FS, BAY14-2222) intravenously (IV), 3 times per week. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) for patients exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Prophylaxis treatment includes three times per week administration of 25 IU/kg of Kogenate FS. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
Recombinant Factor VIII on-demand treatment
Participants received Recombinant Factor VIII (Kogenate FS, BAY14-2222) IV for bleeds in accordance with package insert instructions and study physician recommendations.
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Treated according to the Kogenate FS package insert indications and study physician recommendations
Interventions
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Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Prophylaxis treatment includes three times per week administration of 25 IU/kg of Kogenate FS. Dose escalation steps by 5 IU/kg (to 30 IU/kg or 35 IU/kg maximum) exhibiting a bleeding frequency of 12 bleeding episodes per year or greater.
Recombinant Factor VIII (Kogenate FS, BAY14-2222)
Treated according to the Kogenate FS package insert indications and study physician recommendations
Eligibility Criteria
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Inclusion Criteria
* Males aged 18 to 50 years (other countries)
* Subjects with at least 150 prior exposure days with any FVIII
* Subjects who have been on episodic treatment and no known regular prophylaxis treatment for more than 12 consecutive months in the previous 5 years
* Subjects with 6 to 24 bleeding events and/or treatments in the previous 6 months prior to study entry which are documented and available in the subjects medical records. Documentation can include records from previous physicians, specific home treatment records, emergency room or hospital records, x-ray reports, etc. The investigator can also document with a detailed note the number of bleeds reported by the subject in the last 6 months.
* Subjects with inhibitor formation surveillance (inhibitor or recovery testing) over the ten years prior to enrollment documented by the investigator and who do not have a history of any of the following:
* A positive inhibitor titer of 5.0 Bethesda Unit (BU) or greater by either BU assay system at any time since first exposure to exogenous factor VIII
* A positive inhibitor test result of 1.0 or greater performed by the original BU assay at any time in the past 10 years (A subject can have more than one positive inhibitor test of 0.6 or greater by the original BU assay test but all must be less than 1.0 BU using the original BU assay.)
* A positive inhibitor test result of 0.6 or greater performed by the Nijmegen method at any time in the past 10 years
* Subjects with no inhibitor activity by Nijmegen-modified Bethesda assay, either positive (\> 0.6 BU is considered positive) or borderline (\> 0.3 and \< 0.6 BU is considered borderline) as measured in the current study reference laboratory
Exclusion Criteria
* Subjects with thrombocytopenia (platelets \< 100,000/mm3)
* Subjects with abnormal renal function (Cockcroft-Gault Creatinine Clearance value of 60 mL/min or lower)
* Subjects with active hepatic disease (Aspartate aminotransferase \[AST\] or Alanine aminotransferase \[ALT\] \> 5xUpper Limit of Normal (ULN))
* Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study (the following drugs are however allowed: interferon-a treatment for Hepatitis C virus (HCV), Highly active anti-retroviral therapy (HAART) therapy for human immunodeficiency virus (HIV) and/or a total of two courses of pulse treatment with steroids for a maximum of 7 days at 1mg/kg or less)
* Subjects with an absolute CD4 lymphocyte cell count \< 200 cells/mm3 (due to HIV, HCV or another suspected medical condition)
* Subjects with known hypersensitivity to rFVIII, mouse or hamster proteins
* Subjects who are receiving or had received other experimental drugs within 1 month prior to study entry
* Subjects who require any pre-medication to tolerate FVIII injections (e.g. anti-histamines)
* Subjects who are unwilling to comply with study visits or either of the possible treatment regimens
* Subjects who have a planned orthopedic intervention to be performed during the study that may substantially affect bleeding (e.g. surgical or chemical or radiological synovectomy)
* Subjects who are not suitable for participation in this study for any reason, according to the Investigator
* Subjects who have poor joint status as defined by routine need for a wheelchair or unable to ambulate without the assistance of a brace, cane or crutches
* Three or more joints that are already fused or "frozen" also called ankylosis
12 Years
50 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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Tucson, Arizona, United States
Little Rock, Arkansas, United States
Orange, California, United States
Sacramento, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Orlando, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Iowa City, Iowa, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Kansas City, Missouri, United States
Las Vegas, Nevada, United States
Newark, New Jersey, United States
New York, New York, United States
New York, New York, United States
Cleveland, Ohio, United States
Hershey, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Knoxville, Tennessee, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Milwaukee, Wisconsin, United States
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Rosario, Santa Fe Province, Argentina
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Timișoara, Timiș County, Romania
Brasov, , Romania
Bucharest, , Romania
Bucharest, , Romania
Constanța, , Romania
Countries
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References
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Manco-Johnson MJ, Kempton CL, Reding MT, Lissitchkov T, Goranov S, Gercheva L, Rusen L, Ghinea M, Uscatescu V, Rescia V, Hong W. Randomized, controlled, parallel-group trial of routine prophylaxis vs. on-demand treatment with sucrose-formulated recombinant factor VIII in adults with severe hemophilia A (SPINART). J Thromb Haemost. 2013 Jun;11(6):1119-27. doi: 10.1111/jth.12202.
Manco-Johnson MJ, Lundin B, Funk S, Peterfy C, Raunig D, Werk M, Kempton CL, Reding MT, Goranov S, Gercheva L, Rusen L, Uscatescu V, Pierdominici M, Engelen S, Pocoski J, Walker D, Hong W. Effect of late prophylaxis in hemophilia on joint status: a randomized trial. J Thromb Haemost. 2017 Nov;15(11):2115-2124. doi: 10.1111/jth.13811. Epub 2017 Oct 10.
Other Identifiers
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2008-000985-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12800
Identifier Type: -
Identifier Source: org_study_id