Human Fibrinogen - Pharmacokinetics

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

Outcome

Met primary endpoint

paper MCF increased by a mean of 8.9 mm from baseline to 1 h after infusion of FCH (P < 0.0001). PMID 19804533 ↗

Publications

• Results Manco-Johnson MJ, Dimichele D, Castaman G, Fremann S, Knaub S, Kalina U, Peyvandi F, Piseddu G, Mannucci P; FIBRINOGEN CONCENTRATE STUDY GROUP. Pharmacokinetics and safety of fibrinogen concentrate. J Thromb Haemost. 2009 Dec;7(12):2064-9. doi: 10.1111/j.1538-7836.2009.03633.x. Epub 2009 Oct 5.

Drugs

Indications