An Open-Label, Multicenter Evaluation of the Pharmacokinetics Safety and Tolerability of PEG Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection (FRSW117) in Patients With Severe Hemophilia A.
Latest Information Update: 12 Sep 2023
At a glance
- Drugs FRSW 107 (Primary) ; Octocog alfa (Primary)
- Indications Haemophilia A
- Focus Adverse reactions; First in man; Pharmacokinetics
- Sponsors Jiangsu Gensciences
- 06 Sep 2023 Randomized has been removed from the design term as this trial is now an Non-Randomized trial, Primary endpoints has been amended.
- 15 Jun 2023 Results reporting pharmacokinetic and adverse events data from two groups (S1 group; n=6; at dose 25 IU/kg and S2 group; n=7; at dose 50 IU/kg) presented at the 28th Congress of the European Haematology Association
- 27 Jun 2022 Status changed from active, no longer recruiting to completed.