This study primarily will address the safety and secondarily will assess efficacy of GreenGene™ F in subjects with severe hemophilia A previously treated ≥50 exposure days with a GreenGene™ F, and without presence inhibitor to FVIII (Factor VIII).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Prophylaxis safety and efficacy substudy: intra venous infusion, 30 ± 10 IU/kg infusions 3 times per week with dose escalation to 45 ± 10 IU/kg if appropriate, for 50 exposure days
On-demand safety and efficacy substudy: minor bleed = 20 ± 10 IU/kg moderate bleed = 30 ± 10 IU/kg major bleed = 30 - 50 IU/kg
Arkansas Children's Hospital
Little Rock, Arkansas, United States
RECRUITINGLong Island Jewish Medical Center - Hemophilia Treatment Center
New Hyde Park, New York, United States
RECRUITINGNumber of subjects with development of inhibitors
Development of neutralizing antibodies (inhibitors) will be followed during the regular visits, average of 3 months.
Time frame: every 3 months, up to 18 months
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