Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

Phase 3 Completed 54 enrolled Novo Nordisk A/S

NaSingle-groupOpen-labelTreatment

Summary

This trial is conducted globally. The aim of the trial is to investigate the safety and efficacy of nonacog beta pegol (N9-GP) in previously untreated patients with Haemophilia B.

Timeline

Start: 2014-07-02
Primary completion: 2022-10-27
Completion: 2022-10-27

Publications

Background Chan AK, Alamelu J, Barnes C, Chuansumrit A, Garly ML, Meldgaard RM, Young G. Nonacog beta pegol (N9-GP) in hemophilia B: First report on safety and efficacy in previously untreated and minimally treated patients. Res Pract Thromb Haemost. 2020 Jul 29;4(7):1101-1113. doi: 10.1002/rth2.12412. eCollection 2020 Oct.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	nonacog beta pegol	Protein / enzyme biologic	40 iu/kg	Intravenous
Subject	nonacog beta pegol	Protein / enzyme biologic	80 iu/kg	Intravenous

Safety and Efficacy of Nonacog Beta Pegol (N9-GP) in Previously Untreated Patients With Haemophilia B

Summary

Timeline

Publications

Drugs

Indications