NCT00496262

Human Fibrinogen - Pharmacokinetics

Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and clot strength (maximum clot firmness \[MCF\]) in subjects with congenital fibrinogen deficiency. MCF was measured to demonstrate the functional activity of replacement fibrinogen when a fixed dose of human fibrinogen concentrate was administered.

Conditions

• Fibrinogen Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	Human Fibrinogen Concentrate	Single intravenous infusion of 70 mg/kg body weight

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-05-01
• Completion: 2008-05-01
• First posted: 2007-07-04
• Last updated: 2016-09-15
• Results posted: 2009-07-10

Locations

15 sites across 2 countries: United States, Italy