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Pathogen Reduction System

INTERCEPT Blood System for Blood Transfusion Safety (RedeS Trial)

Phase 3

Recruiting

Research Sponsored by Cerus Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- A diagnosis of a bone marrow failure syndrome requiring repeated RBC transfusion for congenital or acquired chronic anemia (e.g., sickle cell anemia, thalassemia, other hemoglobinopathies, myelodysplastic syndrome, aplastic anemia, chemotherapy or stem cell transplant etc.)

- Diagnosis of SCD, either HbSS, HbSC or HbSB0 thalassemia, confirmed by Hb electrophoresis, deoxyribonucleic acid (DNA) analysis or high-performance liquid chromatography (HPLC)

Must not have

Presence of an RBC warm autoantibody with evidence of active hemolysis

Confirmed positive baseline serum/plasma antibody specific to IBS RBC (S 303 treated RBC) as determined by INTERCEPT S 303 antibody screening panel prior to receiving the first study transfusion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 minutes - 24 hours post transfusion

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is designed to study the safety and efficacy of the INTERCEPT Blood System for pathogen reduction of red blood cells in comparison to conventional methods. If successful, the system may be made available in areas where transfusion-transmissible infections are common.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not specified but may include reactions related to the pathogen reduction treatment process compared with standard RBC transfusions. These could involve immune responses or other complications from altered blood components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been diagnosed with SCD through a specific blood test.

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

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I need or will likely need a blood transfusion.

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I am 4 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have tested positive for a specific antibody related to my condition.

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I am at risk of or have had a massive blood loss needing many transfusions.

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I've had reactions to blood transfusions that needed special RBC treatments.

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I have had acute chest syndrome in the past 6 months or hyperhemolysis at any time.

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I am currently receiving kidney dialysis treatment.

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I have G6PD deficiency or need medication that could harm my red blood cells or bone marrow.

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I received a red blood cell transfusion in the last week.

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I have antibodies that make it hard to match my blood type for transfusions.

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I need blood transfusions for my newborn or during pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 minutes - 24 hours post transfusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 minutes - 24 hours post transfusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 minutes - 24 hours post transfusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adjusted hemoglobin increment

Treatment emergent antibodies

Secondary study objectives

Hemoglobin

Adverse Events

Adverse Events of Special Interest (AESI)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: INTERCEPT (Test)Experimental Treatment1 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 Control1 Intervention

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

0 / 15Eligibility criteria met