drugset / Trial / NCT01949792

A Trial Investigating the Pharmacokinetics and Pharmacodynamics of rFVIIa in Patients With Haemophilia A or B With or Without Inhibitors

NCT01949792

Phase 1 Completed 6 enrolled Novo Nordisk A/S
RandomizedCrossoverOpen-labelTreatment

Summary

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of rFVIIa (activated coagulation factor VII) following one single injection of 270 microg/kg compared to three injections of 90 microg/kg rFVIIa in patients with haemophilia.

Timeline

Start
2013-09
Primary completion
2013-11
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator eptacog alfa (activated) Protein / enzyme biologic 90 ug/kg Intravenous
Comparator eptacog alfa (activated) Protein / enzyme biologic 270 ug/kg Intravenous