NCT01562457

Intra-subject Variability Following Administrations of Activated Recombinant Human Factor VII in Haemophilia Patients in a Non-bleeding State

A Randomised, Open-label, Multi-centre Trial Investigating the Intra-subject Variability of ROTEM® and TEG® Parameters Following Two Intravenous Administrations of the Same Dose of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Haemophilia Patients in a Non-bleeding State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted in Asia and Europe. The aim of this trial is to evaluate the intra-subject variability of thromboelastographic parameters (TEG® and ROTEM®) following two administrations of activated recombinant human factor VII in haemophilia patients in a non bleeding state. The TEG® parameters are: R time (Reaction Time), K time (K Time (arbitrary measurement)), a (a angle), MA (Maximum Amplitude) and LY30 (Lysis 30 min after MA) while the ROTEM® parameters are: CT (Clotting Time), CFT (Clot Formation Time), a (a angle), MCF (Maximum Clot Firmness) and LI60 (Lysis index 60 min after CT).

Conditions

• Congenital Bleeding Disorder
• Haemophilia A
• Haemophilia B

Interventions

Type	Name	Description
DRUG	activated recombinant human factor VII	Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)

Timeline

• Start date: 2005-11-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2012-03-23
• Last updated: 2016-05-12

Locations

3 sites across 3 countries: France, Germany, Israel