drugset / Trial / NCT01563471
Safety and Tolerability of Intravenous Doses of Activated Recombinant Human Factor VII in Healthy Volunteers
RandomizedCrossoverDouble-blindTreatment
Summary
This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics of three different single doses activated recombinant human factor VII in Caucasian and Japanese healthy subjects.
Timeline
- Start
- 2001-10
- Primary completion
- 2002-07
- Completion
- 2002-07
Publications
- Results Fridberg MJ, Hedner U, Roberts HR, Erhardtsen E. A study of the pharmacokinetics and safety of recombinant activated factor VII in healthy Caucasian and Japanese subjects. Blood Coagul Fibrinolysis. 2005 Jun;16(4):259-66. doi: 10.1097/01.mbc.0000169218.15926.34.
- Results Levy JH, Fingerhut A, Brott T, Langbakke IH, Erhardtsen E, Porte RJ. Recombinant factor VIIa in patients with coagulopathy secondary to anticoagulant therapy, cirrhosis, or severe traumatic injury: review of safety profile. Transfusion. 2006 Jun;46(6):919-33. doi: 10.1111/j.1537-2995.2006.00824.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | eptacog alfa (activated) | Protein / enzyme biologic | 40 ug/kg | Intravenous |
| Subject | eptacog alfa (activated) | Protein / enzyme biologic | 80 ug/kg | Intravenous |
| Subject | eptacog alfa (activated) | Protein / enzyme biologic | 160 ug/kg | Intravenous |