drugset / Trial / NCT02920398

A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Safety of Turoctocog Alfa Pegol From the Pivotal Process and Turoctocog Alfa Pegol From the Commercial Process in Patients With Severe Haemophilia A

NCT02920398 ↗

Phase 1 Completed 21 enrolled Novo Nordisk A/S
RandomizedCrossoverDouble-blindTreatment

Summary

Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia A

Timeline

Start
2016-10-04
Primary completion
2017-04-07
Completion
2017-04-07

Drugs

EvaluationDrugModalityDoseRoute
Subject turoctocog alfa pegol Protein / enzyme biologic 50 iu/kg Intravenous

Indications