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NCT04426591 · ClinicalTrials.gov registry record · Phase 1
Red Blood Cell Survival in Sickle Cell Disease
A Phase 1 study of Sickle Cell Disease, sponsored by Marianne Yee.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 3
- Study locations
NCT04426591 is a Phase 1 study of Sickle Cell Disease that has completed, run by Marianne Yee. The registered enrollment target is 22 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (92% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT04426591, a Phase 1 study of Sickle Cell Disease, has completed, sponsored by Marianne Yee.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a single-arm, mechanistic clinical trial to measure predictors of senescence and the in vivo survival of transfused red blood cells (RBCs) in individuals with sickle cell disease (SCD) receiving chronic transfusion therapy (CTT). Chronic transfusion in patients with SCD is a common treatment. The efficacy of RBC transfusion therapy to treat or prevent complications of SCD may be hampered by variable survival of the transfused donor RBC. The overall aim is to see how long RBC survive in SCD patients who are chronically transfused. When a study participant has a regular blood transfusion the researchers will label a small portion of the RBCs that are transfused with biotin. The participant will return at Day 1, weekly for 3 months and monthly for 3 months to measure how long those RBCs survive. An optional sub-study using INTERCEPT RBCs will mirror the main study but will use INTERCEPT RBCs that have biotinylated for 1 RBC unit.
Conditions Studied
Interventions
- DRUG Biotin Labeled Red Blood Cells
- DEVICE INTERCEPT Blood System
Study Locations (3)
Georgia
- Hughes Spalding Children's Hospital - Atlanta
- Childrens Healthcare of Atlanta - Atlanta
- Grady Health System - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-10-29 |
| Est. Completion | 2025-04-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04426591
The ClinicalTrials.gov registry entry for NCT04426591 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (92% lower). The listed sponsor is Marianne Yee, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which Biotin Labeled Red Blood Cells is the first listed.
NCT04426591 reports 3 study locations spanning 1 distinct geographic area - top geographies include Georgia.
Frequently Asked Questions
What is clinical trial NCT04426591 about?
NCT04426591 is a clinical study titled "Red Blood Cell Survival in Sickle Cell Disease". This is a single-arm, mechanistic clinical trial to measure predictors of senescence and the in vivo survival of transfused red blood cells (RBCs) in individuals with sickle cell disease (SCD) receiving chronic transfusion therapy (CTT). Chronic transfusion in patients with SCD is a common treatment...
What is the current status of trial NCT04426591?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2021-10-29. Estimated completion is 2025-04-30.
What conditions does trial NCT04426591 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT04426591?
The interventions under investigation include: Biotin Labeled Red Blood Cells (DRUG), INTERCEPT Blood System (DEVICE).
Who is sponsoring clinical trial NCT04426591?
This trial is sponsored by Marianne Yee, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04426591 being conducted?
This trial has 3 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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