drugset / Trial / NCT01562158
Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation
RandomizedParallel-groupDouble-blindTreatment
Summary
This trial is conducted in Asia, Europe and Oceania. The aim of this trial is to evaluate the efficacy of placebo and activated recombinant human factor VII in patients having undergone allogeneic or autologous stem cell transplantation.
Timeline
- Start
- 2001-04
- Primary completion
- 2003-10
- Completion
- 2003-10
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 |