drugset / Trial / NCT01386528

Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B

NCT01386528

Phase 3 Completed 13 enrolled Novo Nordisk A/S
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This trial is conducted in Africa, Asia, Europe and the United States of America (USA). The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.

Timeline

Start
2012-06-07
Primary completion
2013-12-01
Completion
2013-12-01

Publications

  • Background Escobar M, Colberg T, Karim F, Caliskan U, Chowdary P, Giangrande P, Giermasz A, Mancuso ME, Serban M, Tsay W, Zak M and Mahlangu J. Perioperative hemostatic management of major surgery in hemophilia B with long-acting recombinant glycopegylated factor IX: results from the paradigm™3 clinical trial. Journal of Thrombosis and Haemostasis (Abstracts) 2015; 13 (Supplement S2): 1-997 [OR348]

Drugs

EvaluationDrugModalityDoseRoute
Subject nonacog beta pegol Protein / enzyme biologic Intravenous