NCT01619046

Safety, Efficacy and Pharmacokinetics of GreenGene™ F to Previously Treated Patients With Severe Hemophilia A

Determination of Safety, Efficacy and Pharmacokinetics of GreenGene™ F in Previously Treated Patients 12 Years of Age or Older Diagnosed With Severe Hemophilia A

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, efficacy and pharmacokinetics of GreenGene™ F in subjects with severe hemophilia A previously treated (\> 150 exposure days) with a Factor VIII concentrate and without presence or history of inhibitors to FVIII (Factor VIII).

Conditions

• Hemophilia A

Interventions

Type	Name	Description
BIOLOGICAL	GreenGene™ F and an approved recombinant Factor VIII product	one 50 IU/kg, intra-venous infusion over 5 minutes, Infusion rate \< 10 mL/min
BIOLOGICAL	GreenGene™ F	intra-venous infusion, 30 ± 5 IU/kg infusions 3 times per week with dose escalation to 45 ± 5 IU/kg if appropriate, for 50 exposure days
BIOLOGICAL	GreenGene™ F	intra-venous infusion, On-demand safety and efficacy substudy: minor bleed = 10-20 IU/kg moderate bleed = 15-30 IU/kg major bleed = 30-50 IU/kg
BIOLOGICAL	GreenGene™ F	intra venous infusion, Surgical substudy: Minor surgery including tooth extraction = Post in fusion FVIII level of 60-100% of normal. A single bolus infusion (30-50 IU/kg) beginning within one hour of the operation. Optional additional dosing every 12 to 24 hours as needed to control bleeding. Major surgery = Pre- and post infusion FVIII level 80-120% of normal. Preoperative bolus infusion: 40-60 IU/kg. Verified 100% activity prior to surgery. Maintenance bolus infusion (40-60 IU/kg) repeat infusions every 8 to 24 hours, depending on the desired level.

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-07-01
• Completion: 2015-09-01
• First posted: 2012-06-14
• Last updated: 2014-07-03

Locations

34 sites across 7 countries: United States, Canada, New Zealand, Poland, Russia, Ukraine, United Kingdom