Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A

Phase 1 Completed 50 enrolled Novo Nordisk A/S

NaSingle-groupOpen-labelTreatment

Summary

The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients with severe haemophilia A.

Timeline

Start: 2017-01-30
Primary completion: 2018-10-15
Completion: 2018-10-15

Publications

Klamroth R, Feistritzer C, Friedrich U, Lentz SR, Reichwald K, Zak M, Chowdary P. Pharmacokinetics, immunogenicity, safety, and preliminary efficacy of subcutaneous turoctocog alfa pegol in previously treated patients with severe hemophilia A (alleviate 1). J Thromb Haemost. 2020 Feb;18(2):341-351. doi: 10.1111/jth.14660. Epub 2019 Nov 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	turoctocog alfa pegol	Protein / enzyme biologic	12.5 iu/kg	Subcutaneous
Subject	turoctocog alfa pegol	Protein / enzyme biologic	25 iu/kg	Subcutaneous
Subject	turoctocog alfa pegol	Protein / enzyme biologic	50 iu/kg	Subcutaneous
Subject	turoctocog alfa pegol	Protein / enzyme biologic	100 iu/kg	Subcutaneous
Subject	turoctocog alfa pegol	Protein / enzyme biologic	2000 iu	Subcutaneous
Subject	turoctocog alfa pegol	Protein / enzyme biologic	4000 iu	Subcutaneous

Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A

Summary

Timeline

Publications

Drugs

Indications