Proven safe and effective
The INTERCEPT Blood System for plasma is intended to be used for the ex vivo preparation of pathogen-reduced, whole blood derived or apheresis plasma in order to reduce the risk of transfusion-transmitted infection (TTI).
The safety and efficacy of INTERCEPT Blood System processed plasma (“INTERCEPT Plasma”) has been supported by hemovigilance programs and several clinical trials. INTERCEPT Plasma has been demonstrated to effectively support patients with acquired coagulation factor deficiencies resulting from liver disease or liver transplant, those undergoing therapeutic plasma exchange (TPE) due to TTP, and those undergoing liver transplantation.1
Active hemovigilance (HV) programs provide a comprehensive view of transfusions and potential adverse events via the surveillance of blood donations throughout the transfusion chain. Hemovigilance programs tracking the routine use of over 200,000 INTERCEPT-treated plasma units have demonstrated therapeutic efficacy with an adverse event profile consistent with untreated plasma.1,2-6
*“ATR” refers to Acute Transfusion Reactions
INTERCEPT Plasma maintains hemostatic potency, as shown by the retained activity of key coagulation factors.1
|Factor||Untreated Plasma||INTERCEPT Plasma|
|Global Coagulation Parameters|
|Prothrombin Time (seconds)||13.1||14.4|
|Activated Partial Thromboplastin Time (aPTT) (seconds)||24.2||27.0|
|Coagulation Factors and Proteins of the Hemostatic System|
|Factor II (IU/mL)||1.03||0.93|
|Factor V (IU/mL)||0.91||0.82|
|Factor VII (IU/mL)||0.99||0.81|
|Factor VIII (IU/mL)||0.91||0.73|
|Factor IX (IU/mL)||1.12||0.93|
|Factor X (IU/mL)||0.95||0.83|
|Factor XI (IU/mL)||1.02||0.90|
|vWF Ristocetin Cofactor Activity||1.01||0.97|
|ADAMTS-13 (Antigenic) (%)||124.7||128.8|
|ADAMTS-13 (Functional) (%)||93.4||87.5|
|Protein C (IU/mL)||0.95||0.86|
|Protein S (IU/mL)||1.08||1.04|
|Proteins of the Fibrinolytic System|
|Alpha-2-plasmin inhibitor (IU/mL)||1.00||0.85|
|Markers of Coagulation Activation|
|Thrombin-Antithrombin Complexes (µg/mL)||2.4||2.3|
|Factor VIIa (ng/mL)||<3.6||<3.6|
Data shown is for whole blood derived plasma frozen within 24 hours. For apheresis plasma, please see package insert.
The safety and efficacy of INTERCEPT-treated plasma has been evaluated in a number of prospective clinical studies, with a total of 42 healthy subjects and 203 patients requiring plasma transfusion. All studies met primary endpoints.
|Healthy subjects (N=15)||Ph1; Randomized, single-blind, crossover.||Comparable coagulation factor levels attained between test and control FFP.7|
|Healthy subjects, warfarin anticoagulated (N=27)||Ph2; Randomized, single-blind, crossover.||Comparable prothrombin time and FVII kinetics between test and control FFP.7|
|Multiple coagulation deficiencies (N=13)||Ph2; Randomized, double-blind, parallel group.||INTERCEPT plasma was safe and well tolerated by patients impaired with hepatic function. Comparable hemostatic activity attained between test and control FFP.8|
|Congenital coagulation deficiencies (N=34)||Ph3A; Open label, single arm.||Comparable recovery, pharmacokinetic performance, and PT/PTT attained between test and control FFP.8|
|Acquired coagulation deficiencies (N=121)||Ph3B; Randomized, double-blind, parallel group.||Comparable coagulation responses and clinical hemostasis were attained between test and control FFP.9|
|Thrombotic thrombocytopenic purpura (TTP) (N=35)||Ph3C; Randomized, double-blind, parallel group.||Remission rates, time to remission, relapse rates, and time to relapse, as well as number of TPE and volume of FFP required were comparable between INTERCEPT-treated and conventional FFP.10|
- The INTERCEPT Blood System for Plasma Package Insert, December 16, 2014.
- Cazenave JP et al. Transfusion 2010;50:1210-1219.
- Bost V et al. Vox Sanguinis 2013;104:337-341.
- Afssaps Rapport Annuel Hemovigilance 2009.
- Afssaps Rapport Annuel Hemovigilance 2010.
- ANSM Rapport Annuel Hemovigilance 2011.
- Hambleton J et al. Transfusion 2002;42:1302-1307.
- de Alarcon P et al. Transfusion 2005;45:1362-1372.
- Mintz PD et al. Blood 2006;107:3753-3760.
- Mintz PD et al. Transfusion 2006;46:1693-1704.