WithdrawnPhase 2

Biotin-Acridine Red Cell Exchange Kinetics

Stopped: This study has been suspended due to a lack of funding. The protocol will be reconsidered within the next 6-12 months if/as funding becomes available.

0Started 2025-10-15

Plain-language summary

The primary objective of the study is to describe the recovery and survival of pathogen-reduced (PR) red blood cells (RBCs) prepared and stored with the INTERCEPT Blood System for RBCs® (hereafter referred to as INTERCEPT RBCs) in patients with sickle cell disease (SCD) undergoing red cell exchange (RCE) therapy, utilizing flow cytometry for biotin and acridine RBC surface markers.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥18 years * homozygous sickle cell disease (HbSS) or Hemoglobin S-β-thalassemia (HbSβ0) SCD * Receiving RCE for ≥3 months prior to enrollment and scheduled to undergo at least 4 sequential RCE episodes during the period of enrollment in the study Exclusion Criteria: * Anticipated cessation of RBC transfusion therapy in the next ≤2 months * Planned stem cell transplant or gene therapy in the next 6 months * Delayed hemolytic transfusion reaction in the past 3 months * History of hyperhemolysis syndrome at any time * Consuming high-dose biotin or raw egg supplements * Current pregnancy * Antibody specific to INTERCEPT RBCs or biotinylated red blood cells (BioRBCs) at baseline * Patients with RBC alloantibodies that make it difficult to provide antigen matched blood.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Recovery

Timeframe: 24 hour

Correlation between the biotin and acridine markers

Timeframe: 6 months

Survival

Timeframe: 6 months

Acridine loss

Timeframe: 6 months

Trial details

NCT IDNCT07155031

SponsorCerus Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

View on ClinicalTrials.gov More Sickle Cell Disease trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.