drugset / Trial / NCT02137850
Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
NaSingle-groupOpen-labelTreatment
Summary
This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of turoctocog alfa pegol (N8-GP) in previously untreated patients (PUPs) with haemophilia A.
Timeline
- Start
- 2014-06-26
- Primary completion
- 2023-06-07
- Completion
- 2023-06-07
Publications
- Kenet G, Young G, Chuansumrit A, Matsushita T, Yadav V, Zak M, Male C. The immunogenicity, safety, and efficacy of N8-GP in previously untreated patients with severe hemophilia A: pathfinder6 end-of-trial results. J Thromb Haemost. 2023 Nov;21(11):3109-3116. doi: 10.1016/j.jtha.2023.07.030. Epub 2023 Aug 18.
- Male C, Konigs C, Dey S, Matsushita T, Millner AH, Zak M, Young G, Kenet G. The safety and efficacy of N8-GP (turoctocog alfa pegol) in previously untreated pediatric patients with hemophilia A. Blood Adv. 2023 Feb 28;7(4):620-629. doi: 10.1182/bloodadvances.2022007529.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | turoctocog alfa pegol | Protein / enzyme biologic | 20 unknown | Intravenous |
| Subject | turoctocog alfa pegol | Protein / enzyme biologic | 60 iu/kg | Intravenous |
| Subject | turoctocog alfa pegol | Protein / enzyme biologic | 75 unknown | Intravenous |