drugset / Trial / NCT00922792

Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B

NCT00922792 ↗

Phase 1 Completed 8 enrolled Novo Nordisk A/S
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.

Timeline

Start
2009-06
Primary completion
2009-09
Completion
2009-09

Drugs

EvaluationDrugModalityDoseRoute
Subject EPTACOG ALFA PEGOL (ACTIVATED) Protein / enzyme biologic 0.2 mg/kg Intravenous
Subject EPTACOG ALFA PEGOL (ACTIVATED) Protein / enzyme biologic 100 mg/kg Intravenous