Clinical Trial: Fibrinogen Concentrate (Human) − Efficacy and Safety Study

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Efficacy and Safety of Fibrinogen Concentrate (Human) (FCH) for On-demand Treatment of Acute Bleeding in Subjects With Congenital Fibrinogen Deficiency

Brief Summary:

This is a multinational, multicenter, prospective, open-label historically controlled Phase IIIb non-inferiority clinical trial on the efficacy and safety of Fibrinogen Concentrate (Human).

It is estimated that 150-300 patients in the U.S. suffer from afibrinogenemia. Substitution with cryoprecipitate or alternative treatments have limited safety and efficacy.

The primary purpose of the study is to demonstrate the hemostatic efficacy of Fibrinogen Concentrate (Human) by adequately controlling acute bleeding (spontaneous or after trauma) in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia). Cryoprecipitate hemostatic efficacy data from a retrospective physician survey will be used as a historical control.


Detailed Summary:
Sponsor: CSL Behring

Current Primary Outcome: Clinical assessment of hemostatic efficacy [ Time Frame: 24 hours after last infusion or at Day 14 (whichever occurs first) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Maximum clot firmness (MCF) [ Time Frame: Prior to and 60 minutes after the end of each infusion ]
  • Fibrinogen plasma level [ Time Frame: 60 minutes, 3 hours, 6 hours, and 12 hours after the end of the first infusion; before and 60 minutes after each subsequent infusion ]
  • In vivo recovery of fibrinogen [ Time Frame: 60 minutes, 3 hours, 6 hours and 12 hours after the end of the first infusion; before and 60 minutes after the end of each subsequent infusion and at the time of the overall clinical assessment of hemostatic efficacy ]
  • Virus safety markers [ Time Frame: Day 1 to Day 45 ]


Original Secondary Outcome: Same as current

Information By: CSL Behring

Dates:
Date Received: June 8, 2009
Date Started: October 2009
Date Completion:
Last Updated: May 6, 2014
Last Verified: May 2014