Transfusion Reaction, HemolyticPhase 2ChallengeNCT07152379
Challenge Transfusion of INTERCEPT Pathogen Reduced Red Blood Cells (RBCs) in Subjects With or Without Pre-existing Antibodies to INTERCEPT RBCs
A Phase 2 study testing 30-40 mL of INTERCEPT RBCs and ~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCs in people with Transfusion Reaction, Hemolytic, run by Cerus Corporation at 1 site in United States.
Trial summary
This study aims to determine whether transfusion of INTERCEPT RBCs into patients with pre-existing antibodies to INTERCEPT RBCs will result in increased antibody titer indicative of a secondary immune response, and whether these immune responses would be associated with clinical adverse events, increased RBC… Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Transfusion Reaction, Hemolytic
- What is being tested?
- 30-40 mL of INTERCEPT RBCs and ~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2026to 30 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥4 years in children who meet the requirement of US Code of Federal Regulation (CFR) Title 21, §50.53 as determined by the local Institutional Review Board (IRB).
- Control subjects shall have no current or previously documented antibodies to INTERCEPT RBC.
- Test subjects shall have current or previously documented natural or treatment-emergent antibodies to INTERCEPT RBCs.
- History of prior transfusion with allogeneic blood products (INTERCEPT or non-INTERCEPT treated).
- >120 days from the subjects most recent exposure to Study RBCs (pathogen reduced or non-pathogen reduced - if any) prior to the planned study transfusion.
- Signed and dated informed consent form
Who cannot join
- Foreseeable active blood loss due to trauma, surgery, or pathologic condition during the study period.
- Exposure to another interventional drug or device in a clinical study within 28 days prior to enrollment or concurrently during the study.
- Positive Direct Antiglobulin Test (≥2+) at the time of screening, prior to the first study transfusion.
- Current or historical medical conditions judged by the Investigator to significantly increase the risk of morbidity/mortality due to hemolysis or the medical management of acute hemolysis.
- Treatment with any medication known to affect RBC viability at the time of enrollment (e.g., ribavirin, sulfa drugs, chemotherapy medications, methylene blue, dapsone, levodopa, methyldopa, nitrofurantoin and its derivatives, phenazopyridine, quinidine, and hydantoins)
- History of or development of a drug-associated RBC antibody not associated with INTERCEPT RBCs.
Show all 12Show fewer
- Congenital or acquired immunodeficiency judged by the Investigator to potentially impact the humoral immune response.
- Immunosuppressive therapy within 1 month prior to enrollment or during the study period, including steroids and intravenous immunoglobulin.
- Current or historical RBC alloantibodies that are judged by the Investigator to prevent selection of antigen-negative RBCs for transfusion.
- History of immunoglobulin A (IgA) deficiency, severe allergic reaction to blood product(s), or clinical requirement to receive washed cellular products.
- History of warm autoantibody with hemolysis.
- Subjects who are pregnant, or biologically able to become pregnant and unwilling to remain on medically accepted contraception during this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Colorado Hospital Anschutz
Aurora, Colorado, 80045
Nargis Kahlia, BDS, MPH, 303-724-0333, nargis.kalia@cuanschutz.edu
About this study
Official title: An Open-label, Controlled Phase 2 Study Assessing a Challenge Transfusion of INTERCEPT Pathogen Reduced Red Blood Cells (RBCs) in Subjects With or Without Pre-existing Antibodies to INTERCEPT RBCs
This study aims to determine whether transfusion of INTERCEPT RBCs into patients with pre-existing antibodies to INTERCEPT RBCs will result in increased antibody titer indicative of a secondary immune response, and whether these immune responses would be associated with clinical adverse events, increased RBC clearance, and/or evidence of hemolysis. Because the recovery and survival of fresh allogeneic INTERCEPT RBCs in patients with a diverse group of diseases is poorly characterized, a Control group of subjects without a history or evidence of antibodies to INTERCEPT RBCs may be evaluated as a comparator (Control group subjects may or may not have previously been transfused with INTERCEPT RBCs).
The study will also compare and correlate results from anti-human globulin (AHG) crossmatch using INTERCEPT RBCs prepared for transfusion, with results from indirect antiglobulin testing (IAT) with S 303 treated reagent RBCs (i.e., INTERCEPT RBC screening assay, as used in previous studies) to assess the utility of the AHG crossmatch to define the compatibility of transfused INTERCEPT RBCs
Read the detailed description
This is a prospective, open-label, controlled Phase 2 study. Consented subjects will be screened for currently detectable or previously documented allogeneic, autologous, and INTERCEPT RBC-specific antibodies, assigned to a study arm, then receive a small volume transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs under careful clinical oversight for adverse events including evidence of hemolysis.
Subjects will have blood samples drawn pre-transfusion and over 90 days after transfusion (Days 0, 1, 7, 14, 30, 60, and 90) to detect evidence of primary or secondary immune responses to INTERCEPT RBCs (see Section 8.4.2), and to assess the in vivo post transfusion 24-hour recovery (PTR24) and survival assessed as the half-life [T50], predicted mean/median lifespan, and area-under-the-survival curve (AUC) of the transfused cells.
RBCs and plasma will be collected and stored frozen for further analysis. Specific studies will include gel card-based INTERCEPT RBC antibody screen assay and titer, AHG crossmatch using cells from INTERCEPT RBC units prepared for transfusion, as well as RBC flow cytometric analysis using an antibody specific for acridine to quantitate the proportion of circulating INTERCEPT RBCs and the acridine adduct surface density.
Clinical evidence of hemolysis will be evaluated using routine laboratory tests, including complete blood counts (CBC), chemistry tests and urinalysis.
Test and Control subjects may be recruited from other INTERCEPT RBC studies. Control subjects may be recruited from specific age groups (e.g., children, adults) with specific medical conditions that are known to impact RBC survival in vivo, particularly conditions that are shown to be present in Test subjects (e.g., sickle cell disease, thalassemia).
After an initial challenge dose of 30-40 ml total volume (appx 20 ml RBCs at 50-70% hematocrit), subjects may be consented and enrolled for second and third challenge doses after completion of all study requirements for the subject's prior dose as well as a 120-day minimum wash-out period since the previous study transfusion.
If a subject requires a therapeutic RBC transfusion, had no evidence of hemolysis with the previous challenge dose(s) and remains eligible for a subsequent challenge dose, they may be administered a challenge dose of one full unit volume. Prior to administering each full unit challenge dose, a Data Safety Monitoring Board (DSMB) must perform an interim safety analysis considering all available study data.
Subjects may receive up to three challenge doses of INTERCEPT RBCs.
- Conditions
- Transfusion Reaction, Hemolytic
- Being tested
- 30-40 mL of INTERCEPT RBCs, ~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCs
- Keywords
- INTERCEPT, red blood cells, antibody
- Medical subject headings
- Transfusion Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30-40 mL of INTERCEPT RBCsDevice
Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, or
~30 mL of INTERCEPT RBCs plus 10 mL biotinylated INTERCEPT RBCs Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, in subjects with a history of antibodies to INTERCEPT RBCs.
~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCsDevice
Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, or
~30 mL of INTERCEPT RBCs plus 10 mL biotinylated INTERCEPT RBCs Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, in subjects with a history of antibodies to INTERCEPT RBCs.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Antibodies to INTERCEPT RBC Either Naturally Acquired or Treatment Emergent | Experimental | Test subjects will be selected from the pool of subjects who have documented antibodies to INTERCEPT RBC either naturally acquired (e.g., detected during a pre-transfusion enrollment screening process) or treatment-emergent following an INTERCEPT RBC transfusion. Eligible subjects may have been enrolled in either the Test or Control arms of prior studies; subjects whose randomization status is still blinded may also be enrolled in this study if they have completed the study requirements of the prior study and >120 days have elapsed since exposure to a study RBC product. Receives: Device: 30-40 mL of INTERCEPT RBCs; Device: ~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCs |
| Subjects with history of transfusion without INTERCEPT RBC antibodies | Active comparator | Control subjects will be identified by participating study sites as individuals with a history of allogeneic transfusion(s) without a history of or currently demonstrable INTERCEPT RBC antibodies. Receives: Device: 30-40 mL of INTERCEPT RBCs; Device: ~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute or delayed hemolytic transfusion reactions
Incidence of acute or delayed hemolytic transfusion reactions (AHTR or DHTR) attributed to the study INTERCEPT RBC transfusion, based upon clinical and/or laboratory findings, using Centers for Disease Control (CDC) Hemovigilance criteria.
Measured: 90 days
Clearance
Incidence of rapid clearance (complete clearance by Day 30) of INTERCEPT RBCs assessed by flow cytometry.
Measured: 30 days
Secondary outcomes (7)
Increase in Antibody Titer
Incidence of ≥4-fold increase in titer of INTERCEPT RBC antibodies from baseline (≥2 doubling dilution increase in titer), indicative of a secondary immune response.
Measured: 90 days
In vivo recovery and survival kinetics
In vivo recovery and survival kinetics of INTERCEPT RBCs (PTR24, lifespan, T50 and AUC) in the presence and absence of INTERCEPT RBC antibodies.
In vivo recovery and survival kinetics of INTERCEPT RBCs (PTR24, lifespan, T50 and AUC) in the presence and absence of INTERCEPT RBC antibodies.
Measured: 90 days
Immunoglobulin subclass of INTERCEPT RBC-bound antibodies
Presence of and immunoglobulin subclass of INTERCEPT RBC-bound antibodies assessed by flow cytometry.
Measured: 90 days
RBC alloantibodies or autoantibodies
RBC alloantibodies or autoantibodies not specific to INTERCEPT RBCs that develop during the study period.
Measured: 90 Days
Antibody Characterization
Characterization of INTERCEPT RBC antibodies before and after challenge transfusion including: titer, binding specificity, immunoglobulin class, immunoglobulin subtype, and monocyte monolayer assay test result.
Measured: 90 Days
Characterization of membrane-bound acridine
Characterization of membrane-bound acridine (acridine molecules per RBC) over the lifespan of transfused INTERCEPT RBCs in the presence and absence of INTERCEPT RBC antibodies.
Measured: 90 Days
Comparison of AHG Crossmatch and INTERCEPT RBC antibody indirect antiglobulin test
Percent positive/negative agreement between pre-transfusion AHG crossmatch and INTERCEPT RBC antibody indirect antiglobulin test results with undiluted as well as serially diluted subject plasma.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start10 Oct 2026 (estimated)
- Primary completion30 Sep 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfusion Reaction, HemolyticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cerus Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07152379
- Sponsor's protocol ID
- CLI 00177
- Other IDs
- 75A50124C00046
- Acronym
- Challenge
- Status last verified
- Oct 2026
- First submitted
- 26 Aug 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Controlled Phase 2 Study Assessing a Challenge Transfusion of INTERCEPT Pathogen Reduced Red Blood Cells (RBCs) in Subjects With or Without Pre-existing Antibodies to INTERCEPT RBCs
- ClinicalTrials.gov ID
- NCT07152379
- Acronym / sponsor ID
- Challenge / CLI 00177
- Conditions
- Transfusion Reaction, Hemolytic
- Keywords
- INTERCEPT, red blood cells, antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cerus CorporationIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine whether transfusion of INTERCEPT RBCs into patients with pre-existing antibodies to INTERCEPT RBCs will result in increased antibody titer indicative of a secondary immune response, and whether these immune responses would be associated with clinical adverse events, increased RBC clearance, and/or evidence of hemolysis. Because the recovery and survival of fresh allogeneic INTERCEPT RBCs in patients with a diverse group of diseases is poorly characterized, a Control group of subjects without a history or evidence of antibodies to INTERCEPT RBCs may be evaluated as a comparator (Control group subjects may or may not have previously been transfused with INTERCEPT RBCs).
The study will also compare and correlate results from anti-human globulin (AHG) crossmatch using INTERCEPT RBCs prepared for transfusion, with results from indirect antiglobulin testing (IAT) with S 303 treated reagent RBCs (i.e., INTERCEPT RBC screening assay, as used in previous studies) to assess the utility of the AHG crossmatch to define the compatibility of transfused INTERCEPT RBCs
Detailed description
This is a prospective, open-label, controlled Phase 2 study. Consented subjects will be screened for currently detectable or previously documented allogeneic, autologous, and INTERCEPT RBC-specific antibodies, assigned to a study arm, then receive a small volume transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs under careful clinical oversight for adverse events including evidence of hemolysis.
Subjects will have blood samples drawn pre-transfusion and over 90 days after transfusion (Days 0, 1, 7, 14, 30, 60, and 90) to detect evidence of primary or secondary immune responses to INTERCEPT RBCs (see Section 8.4.2), and to assess the in vivo post transfusion 24-hour recovery (PTR24) and survival assessed as the half-life [T50], predicted mean/median lifespan, and area-under-the-survival curve (AUC) of the transfused cells.
RBCs and plasma will be collected and stored frozen for further analysis. Specific studies will include gel card-based INTERCEPT RBC antibody screen assay and titer, AHG crossmatch using cells from INTERCEPT RBC units prepared for transfusion, as well as RBC flow cytometric analysis using an antibody specific for acridine to quantitate the proportion of circulating INTERCEPT RBCs and the acridine adduct surface density.
Clinical evidence of hemolysis will be evaluated using routine laboratory tests, including complete blood counts (CBC), chemistry tests and urinalysis.
Test and Control subjects may be recruited from other INTERCEPT RBC studies. Control subjects may be recruited from specific age groups (e.g., children, adults) with specific medical conditions that are known to impact RBC survival in vivo, particularly conditions that are shown to be present in Test subjects (e.g., sickle cell disease, thalassemia).
After an initial challenge dose of 30-40 ml total volume (appx 20 ml RBCs at 50-70% hematocrit), subjects may be consented and enrolled for second and third challenge doses after completion of all study requirements for the subject's prior dose as well as a 120-day minimum wash-out period since the previous study transfusion.
If a subject requires a therapeutic RBC transfusion, had no evidence of hemolysis with the previous challenge dose(s) and remains eligible for a subsequent challenge dose, they may be administered a challenge dose of one full unit volume. Prior to administering each full unit challenge dose, a Data Safety Monitoring Board (DSMB) must perform an interim safety analysis considering all available study data.
Subjects may receive up to three challenge doses of INTERCEPT RBCs.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with Antibodies to INTERCEPT RBC Either Naturally Acquired or Treatment Emergent | Experimental | Device: 30-40 mL of INTERCEPT RBCs, Device: ~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCsTest subjects will be selected from the pool of subjects who have documented antibodies to INTERCEPT RBC either naturally acquired (e.g., detected during a pre-transfusion enrollment screening process) or treatment-emergent following an INTERCEPT RBC transfusion. Eligible subjects may have been enrolled in either the Test or Control arms of prior studies; subjects whose randomization status is still blinded may also be enrolled in this study if they have completed the study requirements of the prior study and >120 days have elapsed since exposure to a study RBC product. |
| Subjects with history of transfusion without INTERCEPT RBC antibodies | Active comparator | Device: 30-40 mL of INTERCEPT RBCs, Device: ~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCsControl subjects will be identified by participating study sites as individuals with a history of allogeneic transfusion(s) without a history of or currently demonstrable INTERCEPT RBC antibodies. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥4 years in children who meet the requirement of US Code of Federal Regulation (CFR) Title 21, §50.53 as determined by the local Institutional Review Board (IRB).
- Control subjects shall have no current or previously documented antibodies to INTERCEPT RBC.
- Test subjects shall have current or previously documented natural or treatment-emergent antibodies to INTERCEPT RBCs.
- History of prior transfusion with allogeneic blood products (INTERCEPT or non-INTERCEPT treated).
- >120 days from the subjects most recent exposure to Study RBCs (pathogen reduced or non-pathogen reduced - if any) prior to the planned study transfusion.
Key exclusion criteria (12 listed)
- Foreseeable active blood loss due to trauma, surgery, or pathologic condition during the study period.
- Exposure to another interventional drug or device in a clinical study within 28 days prior to enrollment or concurrently during the study.
- Positive Direct Antiglobulin Test (≥2+) at the time of screening, prior to the first study transfusion.
- Current or historical medical conditions judged by the Investigator to significantly increase the risk of morbidity/mortality due to hemolysis or the medical management of acute hemolysis.
- Treatment with any medication known to affect RBC viability at the time of enrollment (e.g., ribavirin, sulfa drugs, chemotherapy medications, methylene blue, dapsone, levodopa, methyldopa, nitrofurantoin and its derivatives, phenazopyridine, quinidine, and hydantoins)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 30-40 mL of INTERCEPT RBCsTransfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, or ~30 mL of INTERCEPT RBCs plus 10 mL biotinylated INTERCEPT RBCs Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, in subjects with a history of antibodies to INTERCEPT RBCs. | Device | Subjects with Antibodies to INTERCEPT RBC Either Naturally Acquired or Treatment Emergent, Subjects with history of transfusion without INTERCEPT RBC antibodies |
| ~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCsTransfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, or ~30 mL of INTERCEPT RBCs plus 10 mL biotinylated INTERCEPT RBCs Transfusion of fresh (≤14 days old) allogeneic INTERCEPT RBCs, in subjects with a history of antibodies to INTERCEPT RBCs. | Device | Subjects with Antibodies to INTERCEPT RBC Either Naturally Acquired or Treatment Emergent, Subjects with history of transfusion without INTERCEPT RBC antibodies |
Primary outcome
Acute or delayed hemolytic transfusion reactions
Time frame: 90 days
Incidence of acute or delayed hemolytic transfusion reactions (AHTR or DHTR) attributed to the study INTERCEPT RBC transfusion, based upon clinical and/or laboratory findings, using Centers for Disease Control (CDC) Hemovigilance criteria.
Clearance
Time frame: 30 days
Incidence of rapid clearance (complete clearance by Day 30) of INTERCEPT RBCs assessed by flow cytometry.
7 secondary outcomes
Increase in Antibody Titer
Time frame: 90 days
In vivo recovery and survival kinetics
Time frame: 90 days
Immunoglobulin subclass of INTERCEPT RBC-bound antibodies
Time frame: 90 days
RBC alloantibodies or autoantibodies
Time frame: 90 Days
Antibody Characterization
Time frame: 90 Days
Characterization of membrane-bound acridine
Time frame: 90 Days
Comparison of AHG Crossmatch and INTERCEPT RBC antibody indirect antiglobulin test
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 30-40 mL of INTERCEPT RBCs and ~30 mL of INTERCEPT RBCs plus plus 10 mL biotinylated INTERCEPT RBCs in people with Transfusion Reaction, Hemolytic, run by Cerus Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jen Garcia (925-288-6000, JGarcia@cerus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute or delayed hemolytic transfusion reactions (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.