drugset / Trial / NCT01619046
Safety, Efficacy and Pharmacokinetics of GreenGene™ F to Previously Treated Patients With Severe Hemophilia A
Non-randomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2013-03
- Primary completion
- 2015-07
- Completion
- 2015-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | GreenGene™ F | Unknown | 10 iu/kg | Intravenous |
| Comparator | GreenGene™ F | Unknown | 15 iu/kg | Intravenous |
| Comparator | GreenGene™ F | Unknown | 20 iu/kg | Intravenous |
| Comparator | GreenGene™ F | Unknown | 30 iu/kg | Intravenous |
| Comparator | GreenGene™ F | Unknown | 40 iu/kg | Intravenous |
| Comparator | GreenGene™ F | Unknown | 45 iu/kg | Intravenous |
| Comparator | GreenGene™ F | Unknown | 50 iu/kg | Intravenous |
| Comparator | GreenGene™ F | Unknown | 60 iu/kg | Intravenous |