NCT01562158

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

A Multi-centre, Randomised, Double-blind, Parallel Groups, Placebocontrolled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Treatment of Bleeding in Patients Following Stem Cell Transplantation (SCT)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acquired Bleeding Disorder
• Bleeding During/Following Surgery

Interventions

Type	Name	Description
PROCEDURE	standard therapy	Standard treatment of bleeding
DRUG	activated recombinant human factor VII	Two days repeated treatment regimen - low dose administered i.v. (into the vein)
DRUG	activated recombinant human factor VII	Two days repeated treatment regimen - medium dose administered i.v. (into the vein)
DRUG	activated recombinant human factor VII	Two days repeated treatment regimen - high dose administered i.v. (into the vein)
DRUG	placebo	Placebo

Timeline

• Start date: 2001-04-01
• Primary completion: 2003-10-01
• Completion: 2003-10-01
• First posted: 2012-03-23
• Last updated: 2017-01-11

Locations

46 sites across 16 countries: United States, Australia, Austria, Denmark, Finland, France, Germany, Israel, Italy, Poland, Singapore, Spain, Sweden, Switzerland, Thailand, United Kingdom