Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A

NCT01205724 ↗

Phase 1 Completed 27 enrolled Novo Nordisk A/S

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This trial is conducted globally. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of NNC 0129-0000-1003 in previously treated subjects with severe haemophilia A.

Timeline

Start: 2010-09
Primary completion: 2011-04
Completion: 2011-04

Publications

Results Tiede A, Brand B, Fischer R, Kavakli K, Lentz SR, Matsushita T, Rea C, Knobe K, Viuff D. Enhancing the pharmacokinetic properties of recombinant factor VIII: first-in-human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A. J Thromb Haemost. 2013 Apr;11(4):670-8. doi: 10.1111/jth.12161.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	turoctocog alfa pegol	Protein / enzyme biologic	25 iu/kg	Intravenous
Subject	turoctocog alfa pegol	Protein / enzyme biologic	50 iu/kg	Intravenous
Subject	turoctocog alfa pegol	Protein / enzyme biologic	75 iu/kg	Intravenous

Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A

Summary

Timeline

Publications

Drugs

Indications