Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis
NCT ID: NCT02830477
Last Updated: 2023-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
313 participants
OBSERVATIONAL
2016-10-14
2021-03-01
Brief Summary
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In addition the study will capture reported bleed rate, pattern of change in KOVALTRY prophylaxis dose \& dosing frequency, reason for choice of treatment regimen, FVIII product switch pattern, patient treatment satisfaction and adherence, KOVALTRY pharmacokinetic data (if performed), KOVALTRY consumption, as well as safety data.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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BAY81-8973
Previously treated patients receiving IV infusion of KOVALTRY for routine prophylaxis
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973
unmodified, full length recombinant FVIII
Interventions
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Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973
unmodified, full length recombinant FVIII
Eligibility Criteria
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Inclusion Criteria
* Any age
* ≥ 50 exposure days (EDs) to any FVIII product
* Patients with or without history of inhibitors
* Patient with previous history of inhibitors, with at least 2 consecutive negative inhibitor tests and on standard prophylaxis therapy for at least 1 year prior to study entry
* No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor
* Evidence of FVIII inhibitor as measured by the Nijmegen-modified Bethesda assay \[\<0.6 Bethesda units (BU/mL)\] or Bethesda assay \[\< 1.0 BU/mL\] in 2 on consecutives samples
* Documented or clinical suspicion of shortened FVIII half-life (\< 6 hrs)
* Currently on or plan to start prophylaxis therapy with KOVALTRY
* Written informed consent
Exclusion Criteria
* Patients with an additional diagnosis of any bleeding/coagulation disorder other than hemophilia A
* Patients on Immune Tolerance Induction (ITI) treatment at the time of enrollment
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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Children's Rehabilitation Services/ University of South Alabama
Mobile, Alabama, United States
University of Colorado Hemophilia and Thrombosis Center
Aurora, Colorado, United States
University of Florida Health Cancer Center
Gainesville, Florida, United States
Nemours Children's Clinic - Division of Pediatric Hematology/Oncology - Jacksonsville
Jacksonville, Florida, United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States
Henry Ford Hospital Adult Hemophilia and Thrombosis Treatment Center
Detroit, Michigan, United States
Washington University Center for Bleeding and Blood Clotting Disorders
St Louis, Missouri, United States
Hemophilia Center of Western New York
Buffalo, New York, United States
East Carolina University - Brody School of Medicine
Greenville, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Children's Hospital at OU Medical Center
Oklahoma City, Oklahoma, United States
Intermountain Hemophilia & Thrombosis Center
Salt Lake City, Utah, United States
Comprehensive Center for Bleeding Disorders / Blood Center of Wisconsin
Milwaukee, Wisconsin, United States
Multiple Locations, , Belgium
Multiple Locations, , Canada
Multiple Locations, , Colombia
Multiple Locations, , France
Multiple Locations, , Germany
Multiple Locations, , Greece
Multiple Locations, , Italy
Multiple Locations, , Luxembourg
Multiple Locations, , Netherlands
Multiple Locations, , Slovenia
Multiple Locations, , Spain
Multiple Locations, , Taiwan
Countries
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References
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Santoro C, Fuh B, Le PQ, Maes P, Berrueco R, Mingot-Castellano EM, von Mackensen S, Tueckmantel C, Cabre-Marquez JF, Wang M. Efficacy and safety in patients with haemophilia A switching to octocog alfa (BAY 81-8973): Final results of the global real-world study, TAURUS. Eur J Haematol. 2023 Jan;110(1):77-87. doi: 10.1111/ejh.13876. Epub 2022 Oct 17.
Related Links
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Click here to find results for studies related to Bayer products
Other Identifiers
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KV1601
Identifier Type: OTHER
Identifier Source: secondary_id
18559
Identifier Type: -
Identifier Source: org_study_id
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