Drug intelligence / Profile preview

human fibrinogen + prothrombin complex concentrate

Development stage
Phase 3
Lead developer
University Health Network
Modality
Recombinant Proteins and Enzymes
Administration
Intravenous
01

Overview

Fibrinogen + PCC is a combination therapy consisting of human fibrinogen concentrate (FC) and a four-factor prothrombin complex concentrate (PCC). This combination is designed to rapidly replenish essential clotting factors in patients experiencing severe traumatic hemorrhage and acute traumatic coagulopathy (ATC). Fibrinogen (Factor I) is a critical component of the coagulation cascade, serving as the precursor to fibrin, which forms the structural matrix of a blood clot. PCC provides a concentrated source of vitamin K-dependent coagulation factors (Factors II, VII, IX, and X) along with Proteins C and S, which collectively enhance thrombin generation and stabilize clot formation. The combination was specifically investigated in the Phase 4 FiiRST-2 (Factors in the Initial Resuscitation of Severe Trauma 2) trial as a first-line hemostatic strategy compared to standard frozen plasma-based resuscitation protocols. However, the trial was terminated early due to futility after interim analysis showed no superiority in reducing blood product requirements.

Brand names
Fibryga + Octaplex
Other names
FC + PCCfibrinogen concentrate + prothrombin complex concentratefibrinogen + PCC
02

Targets

F10 (Factor Xa)C3Coagulation Factor IXaGPIIb/IIIa (Integrin alpha-IIb/beta-3)PAR (Protease-activated receptors)F2 (Thrombin)T-TM-PC (Thrombin-thrombomodulin-protein C complex)F9 (Coagulation Factor IX)F7 (Coagulation Factor VII)

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