NCT01564563

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

A Multi-center, Randomized, Double-blind, Parallel Groups, Placebo-controlled Trial on Efficacy and Safety of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Treatment of Bleeding in Patients Following Hematopoietic Stem Cell Transplantation (HSCT)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the efficacy of activated recombinant human factor VII in treatment of bleeding in patients having undergone a hematopoietic stem cell transplantation.

Conditions

• Acquired Bleeding Disorder
• Bleeding During/Following Surgery

Interventions

Type	Name	Description
DRUG	standard therapy	Standard treatment of bleeding
DRUG	placebo	Placebo
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 - high dose administered i.v. (into the vein)

Timeline

• Start date: 2002-06-28
• Primary completion: 2003-10-27
• Completion: 2003-10-27
• First posted: 2012-03-28
• Last updated: 2017-02-27

Locations

7 sites across 1 country: United States