Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects

Summary

This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.

Timeline

Start

2009-03

Primary completion

2009-10

Completion

2009-10

Outcome

Met primary endpoint

paper all primary endpoints (incremental recovery, t(1/2), AUC and Cl), and the secondary endpoints (AUC(last) and C(max)) were within the bioequivalence interval of 0.8-1.25. PMID 21443634 ↗

paper In conclusion, N8 is bioequivalent to Advate(®). PMID 21443634 ↗

Publications

• Results Martinowitz U, Bjerre J, Brand B, Klamroth R, Misgav M, Morfini M, Santagostino E, Tiede A, Viuff D. Bioequivalence between two serum-free recombinant factor VIII preparations (N8 and ADVATE(R))--an open-label, sequential dosing pharmacokinetic study in patients with severe haemophilia A. Haemophilia. 2011 Nov;17(6):854-9. doi: 10.1111/j.1365-2516.2011.02495.x. Epub 2011 Mar 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ADVATE	Protein / enzyme biologic	50 iu/kg	—
Subject	turoctocog alfa	Protein / enzyme biologic	50 iu/kg	—

Indications