NCT02027779

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Hemophilia A

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-12-01
• Completion: 2016-02-01
• First posted: 2014-01-06
• Last updated: 2014-01-06

Locations

2 sites across 1 country: United States