NCT01205724

Safety and Pharmacokinetics of NNC 0129-0000-1003 in Subjects With Haemophilia A

A Multi-National, Open-Label, Dose Escalation Trial, Evaluating Safety and Pharmacokinetics of Intravenous Doses of NNC 0129-0000-1003 in Patients With Haemophilia A

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This trial is conducted globally. 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 NNC 0129-0000-1003 in previously treated subjects with severe haemophilia A.

Conditions

• Congenital Bleeding Disorder
• Haemophilia A

Interventions

Type	Name	Description
DRUG	turoctocog alfa pegol	Single dose (low) administered intravenously (into the vein)
DRUG	turoctocog alfa pegol	Single dose (medium) administered intravenously (into the vein)
DRUG	turoctocog alfa pegol	Single dose (high) administered intravenously (into the vein)

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-09-20
• Last updated: 2017-02-10

Locations

18 sites across 7 countries: United States, Germany, Italy, Japan, Switzerland, Turkey (Türkiye), United Kingdom