Human Fibrinogen - Pharmacokinetics

Fibrinogen Deficiency Clinical Trial

Official title: Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Afibrinogenemia
• Fibrinogen Deficiency

• NCT number: NCT00496262
• Study type: Interventional
• Source: CSL Behring
• Status: Completed
• Phase: Phase 2
• Start date: July 2007
• Completion date: May 2008