drugset / Trial / NCT01566786
Safety and Preliminary Efficacy of Activated Recombinant Human Factor VII in Acute Intracerebral Haemorrhage
RandomizedParallel-groupDouble-blindTreatment
Summary
This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor VII (NovoSeven®) in preventing early haematoma growth in acute Intracerebral Haemorrhage (ICH).
Timeline
- Start
- 2001-08
- Primary completion
- 2002-10
- Completion
- 2002-10
Publications
- Results Mayer SA, Brun NC, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T; Europe/AustralAsia NovoSeven ICH Trial Investigators. Safety and feasibility of recombinant factor VIIa for acute intracerebral hemorrhage. Stroke. 2005 Jan;36(1):74-9. doi: 10.1161/01.STR.0000149628.80251.b8. Epub 2004 Nov 29.
- Eilertsen H, Menon CS, Law ZK, Chen C, Bath PM, Steiner T, Desborough MJ, Sandset EC, Sprigg N, Al-Shahi Salman R. Haemostatic therapies for stroke due to acute, spontaneous intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD005951. doi: 10.1002/14651858.CD005951.pub5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | eptacog alfa (activated) | Protein / enzyme biologic | 10 ug/kg | — |
| Subject | eptacog alfa (activated) | Protein / enzyme biologic | 20 ug/kg | — |
| Subject | eptacog alfa (activated) | Protein / enzyme biologic | 40 ug/kg | — |
| Subject | eptacog alfa (activated) | Protein / enzyme biologic | 80 ug/kg | — |
| Subject | eptacog alfa (activated) | Protein / enzyme biologic | 120 ug/kg | — |
| Subject | eptacog alfa (activated) | Protein / enzyme biologic | 160 ug/kg | — |