INTERCEPT Treated RBCs for Anemia

(ReCePI Trial)

No longer recruiting at 17 trial locations

Overseen By Paulette Niemyski

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Cerus Corporation

Must be taking: Aspirin, Clopidogrel, GPIIb/IIIa inhibitors

Must not be taking: Dapsone, Levodopa, Methyldopa, others

Disqualifiers: Pregnancy, Autoimmune hemolytic anemia, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and safety of a new type of red blood cell transfusion for patients with acute anemia undergoing heart or aorta surgery. Researchers seek to determine if treated red blood cells (INTERCEPT Blood System for RBCs) can reduce kidney problems compared to standard blood transfusions. Participants include individuals scheduled for complex heart surgeries, such as multiple bypasses or valve repairs, who may require a blood transfusion. As a Phase 3 trial, this study is the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

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

The trial requires you to stop taking any medications that are known to harm red blood cells, like dapsone or methyldopa. If you're on such medications, you may need to discuss alternatives with your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the INTERCEPT Blood System for Red Blood Cells (RBCs) is generally safe. Studies have found that RBCs treated with this system, which uses chemicals called amustaline and glutathione, are well-tolerated by patients. In one study, these treated RBCs were given to people with anemia, and the results showed no major safety concerns.

Another study tested whole blood treated with amustaline and glutathione, supporting the idea that this method is safe for patients. The treatment aims to reduce germs in the blood, making transfusions safer.

Overall, the INTERCEPT system has been tested in people with conditions like anemia and has shown a good safety record. Side effects are usually mild and uncommon. However, like any treatment, there may be risks, and discussing these with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for anemia?

Researchers are excited about the INTERCEPT Blood System for RBCs because it offers a unique approach to treating anemia by inactivating pathogens and leukocytes in red blood cells. Unlike conventional blood transfusions, which might not address potential infections, INTERCEPT uses amustaline and glutathione to ensure safer blood transfusions. This innovative method could potentially reduce the risk of transfusion-related infections, making it a promising advancement in patient care.

What evidence suggests that the INTERCEPT Blood System for RBCs is effective for treating acute anemia in cardiovascular surgery patients?

This trial will compare the INTERCEPT Blood System for red blood cells (RBCs) with conventional RBCs. Research has shown that the INTERCEPT Blood System effectively treats anemia during heart surgery. Studies have demonstrated its ability to deactivate many bacteria and viruses, reducing the risk of infections from blood transfusions. One study found that INTERCEPT RBCs performed as well as regular RBCs. Early evidence suggests this system holds promise for making blood transfusions safer by preventing infections. ^{1 6 7 8 9}

Who Is on the Research Team?

Richard J Benjamin, MD

Principal Investigator

Cerus Corporation

Are You a Good Fit for This Trial?

This trial is for patients weighing at least 40 kg, aged 11 or older, undergoing complex cardiac surgery such as multiple valve repairs or coronary artery bypass grafts. They must not be pregnant and agree to use reliable birth control if of child-bearing potential. Excluded are those with certain allergies, autoimmune diseases affecting red blood cells, severe kidney or liver issues, recent transfusions or participation in other clinical trials.

Inclusion Criteria

I have had a Batista procedure.

Signed and dated informed consent/assent form

I have had or need a single valve repair or replacement surgery.

Exclusion Criteria

I plan to use my own or directed blood donations.

I am scheduled for a heart transplant.

I needed a heart pump before surgery due to severe heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 30 days

1 visit (in-person)

Treatment

Participants receive RBC transfusions during the acute transfusion support period

7 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days after last study transfusion

Weekly telephone surveillance calls

Extended Follow-up

Assessment of mortality and RRT status, and collection of serological samples

75 days after last study transfusion

1 visit (in-person or offsite)

What Are the Treatments Tested in This Trial?

Interventions

• Control
• INTERCEPT Blood System for RBCs

Trial Overview The study tests the safety and effectiveness of the INTERCEPT Blood System for Red Blood Cells (RBCs) in patients with acute anemia from cardiovascular surgeries. It compares outcomes like renal impairment after receiving INTERCEPT-treated RBCs versus conventional RBC transfusions.

How Is the Trial Designed?

Group I: INTERCEPT (test) Experimental Treatment 1 Intervention

The INTERCEPT treatment process uses amustaline and glutathione together with a processing solution in a single-use disposable set and results in pathogen and leukocyte inactivated RBCs suspended in SAG-M additive solution (INTERCEPT RBCs). The INTERCEPT treatment will be performed on leukocyte reduced RBC components prepared from whole blood collections and suspended in AS-5 additive solution within 24 hours of collection. The test component is allogeneic INTERCEPT RBCs suspended in SAG-M and stored at 1°C to 6 for up to 35 days post-donation and administered intravenously. Dose and schedule of RBC transfusions will be determined by the treating physician.

Group II: Conventional (Control) Active Control 1 Intervention

The control transfusion component is a conventional leukocyte-reduced RBC component in an FDA approved additive solution (AS-1, AS-3 or AS-5) stored at 1°C to 6°C for up to 35 days post-donation and administered intravenously. The Control RBC components will be handled and labeled in a manner so as to maintain blinding. Dose and schedule of RBC transfusions will be determined by the treating physician.

Who Is Running the Clinical Trial?

Cerus Corporation

Lead Sponsor

Trials

20

Recruited

4,800+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10712151/

the Red Cell Pathogen Inactivation (ReCePI) study—protocol ... The INTERCEPT Blood System for RBCs is in development, and in vitro studies have demonstrated inactivation of a wide range of bacterial species, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03037164

INTERCEPT Blood System for RBCs Study in Regions at ... 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)

3. ir.cerus.com ir.cerus.com/press-releases/press-releases-details/2024/Cerus-Corporation-Announces-Positive-Topline-Results-for-the-Phase-3-Clinical-Trial-of-the-INTERCEPT-Blood-System-for-Red-Blood-Cells-in-Cardiovascular-Surgery-Patients/default.aspx

Press Releases Details - Cerus Corporation The trial met its primary efficacy endpoint, demonstrating non-inferiority for INTERCEPT RBCs compared to conventional RBCs as measured by the incidence of ...

4. interceptbloodsystem.com interceptbloodsystem.com/

EMEA Home Page - EMEA The INTERCEPT™ Blood System is designed to reduce the risk of transfusion-transmitted infections by inactivating a broad range of pathogens such as viruses, ...

5. ir.cerus.com ir.cerus.com/press-releases/press-releases-details/2024/Cerus-Corporation-Provides-Updates-on-INTERCEPT-Red-Blood-Cell-Programs-in-the-U.S.-and-Europe/default.aspx

Cerus Corporation Provides Updates on INTERCEPT Red ... In March 2024, Cerus announced positive topline results for the BARDA-funded ReCePI study, a pivotal U.S. Phase 3 clinical trial demonstrating ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04020224

INTERCEPT Safety Evaluation on Whole Blood ... The aim of the study is to assess the safety of whole blood treated with amustaline and glutathione and transfused in patients with anemia. This is a first ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7027779/

Preclinical safety assessment of pathogen reduced red ... The INTERCEPT Blood System for PR of red blood cells concentrates (RBCCs) uses amustaline (S‐303) and glutathione (GSH). Amustaline is a ...

8. sciencedirect.com sciencedirect.com/topics/medicine-and-dentistry/amustaline

Amustaline - an overview | ScienceDirect Topics The INTERCEPT Blood System for RBCs uses a chemical treatment with the small molecule amustaline (S-303) that forms covalent cross-links and adducts with ...

9. researchgate.net researchgate.net/publication/376412388_Evaluation_of_the_efficacy_and_safety_of_amustalineglutathione_pathogen-reduced_RBCs_in_complex_cardiac_surgery_the_Red_Cell_Pathogen_Inactivation_ReCePI_study-protocol_for_a_phase_3_randomized_contro

the Red Cell Pathogen Inactivation (ReCePI) study ... Background The INTERCEPT™ Blood System for Red Blood Cells (RBCs) utilizes amustaline (S‐303) and glutathione (GSH) to inactivate pathogens ...