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 |
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.
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
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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
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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Children's Healthcare of Atlanta Whether treating a toddler in an emergency or supporting a teen...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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500 University Dr
Hershey, Pennsylvania 17033
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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University of Louisville Hospital As the academic hospital at the heart of the Louisville Metro...
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