drugset / Trial / NCT00496262

Human Fibrinogen - Pharmacokinetics

NCT00496262

Phase 2 Completed 15 enrolled CSL Behring
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2007-07
Primary completion
2008-05
Completion
2008-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Fibrinogen Concentrate Human Protein / enzyme biologic 70 mg/kg Intravenous