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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


Phase 2/Phase 3
12 Years
65 Years
Open (Enrolling)
Male
Hemophilia A

Thank you

Trial Information

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


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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Annualized Bleeding Rate (ABR)

Outcome Time Frame:

9 months

Safety Issue:

No

Principal Investigator

Benny Sorensen, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Baxter Healthcare Corporation

Authority:

United States: Food and Drug Administration

Study ID:

261201

NCT ID:

NCT01736475

Start Date:

January 2013

Completion Date:

September 2014

Related Keywords:

  • Hemophilia A
  • Hemophilia A

Name

Location

University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Arkansas Children's HospitalLittle Rock, Arkansas  72202-3591
Cincinnati Children's Hospital Medical CenterCincinnati, Ohio  45229-3039
University of Louisville HospitalLouisville, Kentucky  40202
Duke University Medical CenterDurham, North Carolina  27710
Palmetto HealthColumbia, South Carolina  29203
University of Florida, GainesvilleGainesville, Florida  32611
Penn State Hershey Cancer CenterHershey, Pennsylvania  17033
University of North Carolina Chapel HillChapel Hill, North Carolina  
Tulane University Medical SchoolNew Orleans, Louisiana  70112
Penn Hemophilia ProgramPhiladelphia, Pennsylvania  19104
Puget Sound Blood GroupSeattle, Washington  98104