Safety and Efficacy Extension Study of GreenGene™ F in Previously Treated Patients Diagnosed With Severe Hemophilia A

PHASE3UnknownINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

December 31, 2015

Study Completion Date

February 29, 2016

Conditions
Hemophilia A
Interventions
BIOLOGICAL

GreenGene™ F

"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"

BIOLOGICAL

GreenGene™ F

"On-demand safety and efficacy substudy:~minor bleed = 20 ± 10 IU/kg moderate bleed = 30 ± 10 IU/kg major bleed = 30 - 50 IU/kg"

Trial Locations (2)

11040

RECRUITING

Long Island Jewish Medical Center - Hemophilia Treatment Center, New Hyde Park

72202

RECRUITING

Arkansas Children's Hospital, Little Rock

Sponsors
All Listed Sponsors
collaborator

Atlantic Research Group

OTHER

lead

Green Cross Corporation

INDUSTRY