Clinical Trial: Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Clinical Pharmacology, Efficacy and Safety Study of FGTW in Paediatric Patients With Severe Congenital Fibrinogen Deficiency
Brief Summary: The aim of the study is to evaluate clinical pharmacology, efficacy and safety of FGTW in pediatric patients with congenital fibrinogen deficiency.
Detailed Summary:
Sponsor: Laboratoire français de Fractionnement et de Biotechnologies
Current Primary Outcome:
- Investigator's overall assessment of efficacy of FGTW on hemostasis using a 4-point scale at the end of each bleeding or surgical episode. [ Time Frame: 6 hours or up to 5 days ]
- Terminal half life for Fibrinogen antigen and activity [ Time Frame: 5 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Adverse Events [ Time Frame: Participants will be followed for the duration of their participation in the study, an expected average of 1 year ]
Original Secondary Outcome: Same as current
Information By: Laboratoire français de Fractionnement et de Biotechnologies
Dates:
Date Received: February 26, 2014
Date Started: January 2014
Date Completion:
Last Updated: February 11, 2016
Last Verified: February 2016
