NCT01563458

Safety and Efficacy of Activated Recombinant Human Factor VII in Patients Undergoing Orthotopic Liver Transplantation

A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Dose Exploratory Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in the Reduction of Bleeding in Subjects Undergoing Orthotopic Liver Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Europe, North America and Oceania. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in subjects undergoing orthotopic liver transplantation surgery.

Conditions

• Acquired Bleeding Disorder
• Bleeding During/Following Surgery

Interventions

Type	Name	Description
DRUG	activated recombinant human factor VII	120 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 120 mcg/kg single bolus administration at completion of wound closure
DRUG	activated recombinant human factor VII	60 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 60 mcg/kg single bolus administration at completion of wound closure
DRUG	placebo	Trial drug into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. Single bolus administration at completion of wound closure

Timeline

• Start date: 2001-08-01
• Primary completion: 2003-08-01
• Completion: 2003-08-01
• First posted: 2012-03-27
• Last updated: 2017-01-13

Locations

18 sites across 7 countries: Australia, Canada, France, Germany, Spain, Sweden, United Kingdom