INTERCEPT Blood System for Plasma, pathogen reduction system:

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).

 

INTERCEPT Plasma

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

Shown safe in routine use

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

Year Product Plasma Units ATR*/1000
2009  Untreated Plasma 348,725 0.55
INTERCEPT Plasma 22,933 0.52
2010  Untreated Plasma 329,757 0.59
INTERCEPT Plasma 52,692 0.47
2011  Untreated Plasma 311,482 0.31
INTERCEPT Plasma 68,440 0.31

*“ATR” refers to Acute Transfusion Reactions

Retained plasma coagulation function

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
Fibrinogen (mg/dL) 2.91 2.43
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
Anticoagulant Proteins
Antithrombin III 0.98 0.93
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.

Clinical trials

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.

Population
(sample size)*
Phase (Ph)/
Study Design
Primary Result(s)
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

References

  1. The INTERCEPT Blood System for Plasma Package Insert, December 16, 2014.
  2. Cazenave JP et al. Transfusion 2010;50:1210-1219.
  3. Bost V et al. Vox Sanguinis 2013;104:337-341.
  4. Afssaps Rapport Annuel Hemovigilance 2009.
  5. Afssaps Rapport Annuel Hemovigilance 2010.
  6. ANSM Rapport Annuel Hemovigilance 2011.
  7. Hambleton J et al. Transfusion 2002;42:1302-1307.
  8. de Alarcon P et al. Transfusion 2005;45:1362-1372.
  9. Mintz PD et al. Blood 2006;107:3753-3760.
  10. Mintz PD et al. Transfusion 2006;46:1693-1704.

 

INTERCEPT helps U.S. blood centers to reduce transfusion transmitted infectious risk while providing therapeutically effective plasma to patients.

*Certain non-enveloped viruses (e.g., HAV, HEV, B19 and poliovirus) and Bacillus cereus spores have demonstrated resistance to the INTERCEPT process.