NCT00056589

Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency

A Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII Deficiency

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial was conducted in the United States of America (USA). The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII) in patients with congenital factor XIII deficiency.

Conditions

• Congenital Bleeding Disorder
• Congenital FXIII Deficiency

Interventions

Type	Name	Description
DRUG	catridecacog	Single doses of rFXIII administered intravenously (IV) to two subjects in each of the five dose levels (2, 6, 20, 50 and 75 U/kg).

Timeline

• Start date: 2003-03-01
• Primary completion: 2003-10-01
• Completion: 2003-10-01
• First posted: 2003-03-20
• Last updated: 2017-01-11

Locations

1 site across 1 country: United States