Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)



Status:Completed
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:12 - 65
Updated:11/25/2017
Start Date:January 2013
End Date:July 2014

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A Phase 2/3, Multi-Center, Open Label Study of Efficacy, Safety, and Pharmacokinetics of PEGylated Recombinant Factor VIII (BAX 855) Administered for Prophylaxis and Treatment of Bleeding in Previously Treated Patients With Severe Hemophilia A

To assess efficacy and safety, including immunogenicity of BAX 855 administered as
prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated
patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of
BAX 855.


Main Inclusion Criteria:

- Participant and/or legal representative has/have voluntarily provided signed informed
consent

- Participant is 12 to 65 years old at the time of screening

- Participant is male with severe hemophilia A (Factor VIII (FVIII) clotting activity <
1%) as confirmed by central laboratory at screening after the appropriate washout
period or a documented FVIII clotting activity <1%

- Participant has been previously treated with plasma-derived FVIII concentrates or
recombinant FVIII for ≥150 documented exposure days (EDs)

- Participant is currently receiving prophylaxis or on-demand therapy with FVIII

- Participant is willing and able to comply with the requirements of the protocol

Main Exclusion Criteria:

- Participant has detectable FVIII inhibitory antibodies (≥ 0.6 Bethesda Units (BU)
using the Nijmegen modification of the Bethesda assay) as confirmed by central
laboratory at screening

- Participant has history of FVIII inhibitory antibodies (≥ 0.4 BU using the Nijmegen
modification of the Bethesda assay or ≥ 0.6 BU using the Bethesda assay) at any time
prior to screening

- Participant has been diagnosed with an inherited or acquired hemostatic defect other
than hemophilia A (eg, qualitative platelet defect or von Willebrand's disease).
We found this trial at
18
sites
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
 1-513-636-4200 
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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740 South Limestone Street
Lexington, Kentucky 40536
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Adelaide, South Australia
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Adelaide,
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1405 Clifton Road NE
Atlanta, Georgia 30322
404-785-6000
Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Aurora, Colorado 80045
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Columbia, South Carolina 29203
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3450 Hull Road
Gainesville, Florida 32610
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500 University Dr
Hershey, Pennsylvania 17033
(717) 531-6955
Penn State Milton S. Hershey Medical Center Penn State Milton S. Hershey Medical Center, Penn...
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Kansas City, Missouri 64108
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530 S Jackson St
Louisville, Kentucky 40202
502-562-3226
University of Louisville Hospital As the academic hospital at the heart of the Louisville Metro...
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New Orleans, Louisiana 70112
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Salt Lake City, Utah 84132
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Seattle, Washington 98133
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