Under construction – not a live service
Sign in

NCT07155031WithdrawnPhase 2

Biotin-Acridine Red Cell Exchange Kinetics

Kinetics of Pathogen Reduced Red Blood Cell Clearance in Subjects Undergoing Red Cell Exchange for Sickle Cell Disease

Source: ClinicalTrials.gov · Last updated 22 Sept 2026

Reason given: 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.

Brief summary (registry, in English)

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.

Status (registry)
Withdrawn
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
0 (actual)
First submitted
27 Aug 2025
Start date
15 Oct 2025
Primary completion date
30 Sept 2026
Lead sponsor
Cerus Corporation
NCT number
NCT07155031

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Anticipated cessation of RBC transfusion therapy in the next ≤2 months
  • Planned stem cell transplant or gene therapy in the next 6 months
  • Antibody specific to INTERCEPT RBCs or biotinylated red blood cells (BioRBCs) at baseline

Other illness

  • History of hyperhemolysis syndrome at any time

Other

  • Delayed hemolytic transfusion reaction in the past 3 months
  • Consuming high-dose biotin or raw egg supplements
  • Current pregnancy
  • Patients with RBC alloantibodies that make it difficult to provide antigen matched blood.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.