Clinical Trial: Activated Recombinant Human Factor VII in Patients With Dengue Haemorrhagic Fever
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Comparison of Recombinant Factor VIIa (NovoSeven®) and Standard Haemostatic Replacement Therapy in Patients With Dengu
Brief Summary: This trial is conducted in Asia. The aim of this is to investigate the efficacy and safety of activated recombinant human factor VII (rFVIIa) in achieving haemostasis in patients with Dengue haemorrhagic fever (DHF).
Detailed Summary:
Sponsor: Novo Nordisk A/S
Current Primary Outcome: Proportion of subjects with evidence of bleeding as assessed at 2 hours after first trial product administration
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of subjects requiring standard haemostatic replacement therapy during 2 hours after first trial product administration
- Proportion of subjects with effective haemostatic efficacy at 2 hours after first trial product administration
- Coagulation related variables
- Adverse events
Original Secondary Outcome: Same as current
Information By: Novo Nordisk A/S
Dates:
Date Received: May 14, 2012
Date Started: July 2001
Date Completion:
Last Updated: January 10, 2017
Last Verified: January 2017
