drugset / Trial / NCT01562158

Efficacy and Safety of Activated Recombinant Human Factor VII in Treatment of Bleeding in Patients Following Allogeneic Stem Cell Transplantation

NCT01562158

Phase 2 Completed 100 enrolled Novo Nordisk A/S
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

EvaluationDrugModalityDoseRoute
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

Indications