A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B

Phase 1 Completed 15 enrolled Novo Nordisk A/S

RandomizedCrossoverOpen-labelTreatment

Summary

This trial is conducted in Europe and the United States of America. The aim of this trial is to compare the pharmacokinetics (the exposure of the trial drug in the body) of nonacog beta pegol (N9-GP) and ALPROLIX® in patients with haemophilia B.

Timeline

Start: 2017-03-07
Primary completion: 2017-12-08
Completion: 2017-12-08

Outcome

Met primary endpoint

paper estimated AUC0-inf,norm was significantly greater for N9-GP than rFIXFc (ratio: 4.39; P < 0.0001, based on a two-sided test on 5% significance level). PMID 31011711 ↗

Publications

Escuriola Ettingshausen C, Hegemann I, Simpson ML, Cuker A, Kulkarni R, Pruthi RK, Garly ML, Meldgaard RM, Persson P, Klamroth R. Favorable pharmacokinetics in hemophilia B for nonacog beta pegol versus recombinant factor IX-Fc fusion protein: A randomized trial. Res Pract Thromb Haemost. 2019 Mar 23;3(2):268-276. doi: 10.1002/rth2.12192. eCollection 2019 Apr.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	EFTRENONACOG ALFA	Protein / enzyme biologic	50 iu/kg	Intravenous
Subject	nonacog beta pegol	Protein / enzyme biologic	50 iu/kg	Intravenous