drugset / Trial / NCT00956345
Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This trial is conducted in Europe, Japan and the United States of America (USA). The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of Pegylated Recombinant Factor IX (nonacog beta pegol) in Non-Bleeding Patients with Haemophilia B.
Timeline
- Start
- 2009-08
- Primary completion
- 2010-07
- Completion
- 2010-07
Publications
- Background Negrier C, Knobe K, Tiede A, Giangrande P, Moss J. Enhanced pharmacokinetic properties of a glycoPEGylated recombinant factor IX: a first human dose trial in patients with hemophilia B. Blood. 2011 Sep 8;118(10):2695-701. doi: 10.1182/blood-2011-02-335596. Epub 2011 May 9.
- Background Collins PW, Moss J, Knobe K, Groth A, Colberg T, Watson E. Population pharmacokinetic modeling for dose setting of nonacog beta pegol (N9-GP), a glycoPEGylated recombinant factor IX. J Thromb Haemost. 2012 Nov;10(11):2305-12. doi: 10.1111/jth.12000.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | nonacog beta pegol | Protein / enzyme biologic | 25 iu/kg | Intravenous |
| Subject | nonacog beta pegol | Protein / enzyme biologic | 50 iu/kg | Intravenous |
| Subject | nonacog beta pegol | Protein / enzyme biologic | 100 iu/kg | Intravenous |