drugset
drugset / Trial / NCT02027779

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

NCT02027779 ↗

Phase 3 Unknown 150 enrolled Green Cross Corporation Atlantic Research Group · collab
Non-randomizedParallel-groupOpen-labelTreatment

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).

Timeline

Start
2014-01
Primary completion
2015-12
Completion
2016-02

Drugs

EvaluationDrugModalityDoseRoute
Subject GreenGene™ F Unknown 20 iu/kg Intravenous
Subject GreenGene™ F Unknown 30 iu/kg Intravenous
Subject GreenGene™ F Unknown 45 iu/kg Intravenous
Subject GreenGene™ F Unknown 50 iu/kg Intravenous

Indications

hemophilia A