INTERCEPT Blood System for Blood Transfusion Safety

(RedeS Trial)

Recruiting at11 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Cerus Corporation

Must not be taking: Chemotherapy, others

Disqualifiers: Pregnancy, Breastfeeding, Massive hemorrhage, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Stage A: To evaluate the safety and efficacy of red blood cells (RBCs) prepared with the INTERCEPT Blood System for Red Blood Cells Pathogen Reduction Treatment (PRT) in comparison to conventional RBCs in patients who require RBC transfusion support. Stage B: To provide early access to the INTERCEPT pathogen reduction system for RBC in regions where a substantial proportion of the population has been infected or is at risk of a transfusion-transmissible infection. The objectives and design of Stage B will be reassessed on the completion of Stage A, in consultation with the FDA.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications that affect red blood cell viability or bone marrow function, you may not be eligible to participate.

What data supports the effectiveness of the INTERCEPT Blood System treatment for blood transfusion safety?

The INTERCEPT Blood System has been shown to effectively inactivate pathogens in platelet and plasma components, enhancing safety by reducing the risk of transfusion-transmitted infections. Studies have demonstrated its successful use in diverse patient groups, confirming its safety and efficacy in routine operations. ^{1 2 3 4 5}

Is the INTERCEPT Blood System safe for use in humans?

The INTERCEPT Blood System has been shown to be safe in humans, with a large safety margin and successful use in diverse patient groups. Approximately 700,000 INTERCEPT-treated products have been transfused worldwide, and the system has been in clinical use since 2002, demonstrating safety and tolerability in routine use. ^{1 2 4 5 6}

What makes the INTERCEPT Blood System for Red Blood Cells treatment unique?

The INTERCEPT Blood System for Red Blood Cells is unique because it uses a pathogen inactivation technology with amotosalen and UVA light to reduce the risk of infections from blood transfusions, offering enhanced safety compared to traditional methods. ^{1 2 5 7 8}

Research Team

Eligibility Criteria

This trial is for people aged 4 and older who need regular blood transfusions due to chronic anemia from conditions like sickle cell, thalassemia, or after chemotherapy. They must not be pregnant, agree to birth control if applicable, and can't have had a recent transfusion or certain allergies.

Inclusion Criteria

I need regular blood transfusions due to a long-term anemia condition.

I am part of a study for sickle cell disease needing regular blood exchanges.

I have been in a regular blood transfusion program for at least 3 months.

Exclusion Criteria

My body is attacking its own red blood cells, causing them to break down.

You have a medical record that shows you have low levels of IgA or have experienced serious allergic reactions to blood products in the past.

- A polyspecific-DAT (any strength) in conjunction with pan-reactivity with a commercial IAT antibody screening panel that precludes the identification of underlying alloantibodies or indicates the presence of autoantibody

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive either Test or Control RBCs for up to 28 days in the acute transfusion support period

4 weeks

Multiple visits as needed for transfusions

Extension

Optional 6-month extension period for patients requiring repeated transfusion for chronic anemia

6 months

Regular visits for transfusions

Follow-up

Participants are monitored for safety and effectiveness after treatment

75 days

2 visits (in-person) at Day 28 and Day 75

Treatment Details

Interventions

• INTERCEPT Blood System for Red Blood Cells (Pathogen Reduction System)

Trial Overview The study tests the INTERCEPT Blood System for treating Red Blood Cells (RBCs) against conventional methods in patients needing RBC support. It aims to see if this system is safe and works well in areas at risk of Zika virus through blood transfusion.

Participant Groups

Group I: INTERCEPT (Test) Experimental Treatment 1 Intervention

Red blood cell components treated with the INTERCEPT Blood System for Red Blood Cells ordered and administered to study patients by their treating physicians according to the local standards of care

Group II: Conventional (Control) Active Control 1 Intervention

Conventional RBC components ordered and administered to study patients by their treating physicians according to the local standards of care

Who Is Running the Clinical Trial?

Cerus Corporation

Lead Sponsor

Trials

20

Recruited

4,800+

Findings from Research

The INTERCEPT Blood System™ combined with Platelet Additive Solution PAS-IIIM has been validated for use with both apheresis and pooled buffy-coat platelet components, ensuring compliance with European and French quality standards over a 5-day storage period.

The study confirmed that PAS-IIIM provides superior metabolic and activation profiles for treated platelets compared to the previous PAS-III solution, enhancing the overall effectiveness of the INTERCEPT™ process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vitro assessment of apheresis and pooled buffy coat platelet components suspended in plasma and SSP+ photochemically treated with amotosalen and UVA for pathogen inactivation (INTERCEPT Blood System™). Chavarin, P., Cognasse, F., Argaud, C., et al.[2014]

In a study of 176 patients with acute myeloid leukemia, pathogen-reduced platelets (PR_PLT) showed similar effectiveness to untreated platelets in preventing bleeding when transfused at doses greater than 0.65×10^11/10 kg, allowing for transfusions every 48 hours.

For patients experiencing WHO grade 2 bleeding, PR_PLT transfusions above the same threshold and stored for less than 4 days were more effective in stopping bleeding, highlighting the importance of both quantity and quality in platelet transfusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic efficacy of platelet transfusion treated with amotosalen/UVA pathogen inactivation technology (INTERCEPTTM Blood System) in acute myeloid leukemia patients undergoing chemotherapy with curative intent: a single center experience. Ladaique, P., Etienne, JM., Pedini, P., et al.[2023]

The INTERCEPT Blood System effectively inactivated a wide range of pathogens in plasma, achieving high log-reduction levels for viruses and bacteria, which suggests it can significantly reduce the risk of transfusion-transmitted diseases.

Despite the pathogen inactivation, the treatment preserved a substantial portion of coagulation factor activity, with retention rates between 72% to 98%, indicating that plasma function remains adequate for transfusion purposes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photochemical treatment of plasma with amotosalen and long-wavelength ultraviolet light inactivates pathogens while retaining coagulation function. Singh, Y., Sawyer, LS., Pinkoski, LS., et al.[2020]

The study evaluated the safety and efficacy of pathogen-inactivated platelet concentrates (PC) using the INTERCEPT Blood System™ in 51 patients with hematological diseases, finding a low incidence of acute transfusion reactions (1.6%) and no bleeding complications related to the transfusions.

The results indicate that INTERCEPT technology is safe and effective for treating thrombocytopenia, allowing for routine use without the need for additional testing like CMV screening or bacterial testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and clinical efficacy of platelet components prepared with pathogen inactivation in routine use for thrombocytopenic patients. Schlenke, P., Hagenah, W., Irsch, J., et al.[2019]

The INTERCEPT Blood System, which uses amotosalen and UVA light, effectively inactivates a wide range of pathogens including viruses, bacteria, and protozoa, ensuring enhanced safety in blood transfusions.

With approximately 700,000 INTERCEPT-treated products transfused since its clinical use began in 2002, the system has demonstrated robust safety and efficacy, integrating well into routine blood center operations and showing tolerability in diverse patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pathogen Inactivation of Platelet and Plasma Blood Components for Transfusion Using the INTERCEPT Blood System™ Irsch, J., Lin, L.[2022]

In a study of 50 pooled platelet concentrates, 24% did not meet the INTERCEPT blood system requirements for pathogen inactivation, particularly due to insufficient volumes and excessive red blood cell contamination.

The photochemical treatment process resulted in a significant loss of platelet dose and volume, with 25% of treated units failing to meet the European guideline for platelet dose, highlighting the need for optimization of processing steps before treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of processing characteristics of photochemically treated pooled platelets: target requirements for the INTERCEPT Blood System comply with routine use after process optimization. Picker, SM., Speer, R., Gathof, BS.[2023]

A study of 9673 platelet transfusions treated with riboflavin and ultraviolet light showed that while more platelets were needed per patient during the PRT period (7.8 vs. 4.2), the safety improved with fewer febrile and allergic reactions (2.5% vs. 1.2% and 0.16% vs. 0.08%, respectively).

The implementation of pathogen reduction technology (PRT) led to significant cost savings of €284,805.58 due to a drastic reduction in outdated platelets from 16.8% to 0.72%, making it a financially viable option despite the increased platelet usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Our experience in riboflavin and ultraviolet light pathogen reduction technology for platelets: from platelet production to patient care. Jimenez-Marco, T., Garcia-Recio, M., Girona-Llobera, E.[2019]

The Intercept Blood System (IBS) for platelets significantly enhances the safety of platelet transfusions by reducing the risk of pathogen transmission, including emerging viruses, making it a valuable option for patients requiring transfusions.

Despite high costs associated with its use, the IBS demonstrates comparable cost-effectiveness to other blood safety measures, suggesting it is a worthwhile investment for improving transfusion safety in various medical conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of transfusion of platelet components prepared with pathogen inactivation treatment in the United States. Bell, CE., Botteman, MF., Gao, X., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

In vitro assessment of apheresis and pooled buffy coat platelet components suspended in plasma and SSP+ photochemically treated with amotosalen and UVA for pathogen inactivation (INTERCEPT Blood System™). [2014]

2. Italy pubmed.ncbi.nlm.nih.gov

Therapeutic efficacy of platelet transfusion treated with amotosalen/UVA pathogen inactivation technology (INTERCEPTTM Blood System) in acute myeloid leukemia patients undergoing chemotherapy with curative intent: a single center experience. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Photochemical treatment of plasma with amotosalen and long-wavelength ultraviolet light inactivates pathogens while retaining coagulation function. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Safety and clinical efficacy of platelet components prepared with pathogen inactivation in routine use for thrombocytopenic patients. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Pathogen Inactivation of Platelet and Plasma Blood Components for Transfusion Using the INTERCEPT Blood System™ [2022]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of processing characteristics of photochemically treated pooled platelets: target requirements for the INTERCEPT Blood System comply with routine use after process optimization. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Our experience in riboflavin and ultraviolet light pathogen reduction technology for platelets: from platelet production to patient care. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of transfusion of platelet components prepared with pathogen inactivation treatment in the United States. [2022]