NCT00956345

Safety of 40K Pegylated Recombinant Factor IX in Non-Bleeding Patients With Haemophilia B

A Multi-Centre, Multi-National, Open-Label, Dose Escalation Trial Evaluating Safety and Pharmacokinetics of Ascending Intravenous Doses of 40K Pegylated Recombinant FIX in Non-Bleeding Patients With Haemophilia B.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Congenital Bleeding Disorder
• Haemophilia B

Interventions

Type	Name	Description
DRUG	nonacog beta pegol	Cohort to receive a single dose of 25U/kg nonacog beta pegol administered intravenously (into the vein)
DRUG	nonacog beta pegol	Cohort to receive a single dose of 50U/kg nonacog beta pegol administered intravenously (into the vein)
DRUG	nonacog beta pegol	Cohort to receive a single dose of 100U/kg nonacog beta pegol administered intravenously (into the vein)

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2009-08-11
• Last updated: 2017-01-20

Locations

19 sites across 8 countries: United States, Denmark, France, Germany, Japan, Spain, Sweden, United Kingdom