NCT01562821

Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy

A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Cirrhotic Patients Scheduled to Undergo Partial Hepatectomy Due to Liver Cancer or Benign Tumours

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Asia. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in cirrhotic patients scheduled to undergo partial hepatectomy due to liver cancer or benign tumours.

Conditions

• Acquired Bleeding Disorder
• Cirrhosis

Interventions

Type	Name	Description
DRUG	activated recombinant human factor VII	An initial bolus dose of 50 mcg/kg body weight (BW) followed by 50 mcg/kg BW every second hour until completion of surgery
DRUG	activated recombinant human factor VII	An initial bolus dose of 100 mcg/kg body weight (BW) followed by 100 mcg/kg BW every second hour until completion of surgery
DRUG	placebo	An initial placebo bolus dose followed by placebo every second hour until completion of surgery

Timeline

• Start date: 2001-07-01
• Primary completion: 2002-12-01
• Completion: 2002-12-01
• First posted: 2012-03-26
• Last updated: 2017-01-13

Locations

7 sites across 3 countries: China, Taiwan, Thailand