drugset / Trial / NCT04592692
A Pharmacokinetic and Clotting Activity Study of FVIII-PEGLip
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to demonstrate that PEGylated liposomes (PEGLip) can shield FVIII from the immune system and inhibitors, and therefore provide a prophylactic FVIII replacement therapy for patients with inhibitors to FVIII.
Timeline
- Start
- 2019-12-23
- Primary completion
- 2022-02-28
- Completion
- 2022-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PEGylated Liposome | Unknown | 22 mg/kg | Intravenous |
| Subject | simoctocog alfa | Protein / enzyme biologic | 35 iu/kg | Intravenous |