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NCT06313398 · ClinicalTrials.gov registry record · Early Phase 1
Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling
A Early Phase 1 study of Sickle Cell Disease and Thalassemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06313398: Recruiting Early Phase 1 study of Sickle Cell Disease and Thalassemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT06313398 is a Early Phase 1 study of Sickle Cell Disease and Thalassemia that is actively recruiting participants, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 100 participants, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06313398, a Early Phase 1 study of Sickle Cell Disease and Thalassemia, is actively recruiting participants, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Sickle cell disease (SCD) is an inherited disorder of the blood. SCD causes red blood cells (RBCs) to die early. This can lead to a shortage of healthy cells. SCD and other blood disorders can be managed with drugs or cured with a bone marrow transplant. Researchers want to know how long RBCs survive in people with SCD and other blood disorders before and after treatment compared to those who had a bone marrow transplant. Objective: To learn how long RBCs survive in the body in people with SCD and other blood disorders compared to those whose disease was cured with a bone marrow transplant. Eligibility: People aged 18 years or older with SCD or another inherited blood disorder. People whose SCD or blood disorder was cured with a bone marrow transplant are also needed. Design: Participants will be screened. They will have a physical exam with blood and urine tests. Participants will have about 7 tablespoons of blood drawn. In the lab, this blood will be mixed with a vitamin called biotin. Biotin sticks to the outside of RBCs. This process is called "biotin labeling of RBCs." The next day, the participant s own biotin-labeled RBCs will be returned to their bloodstream. Participants will return regularly to have smaller blood samples (about 2 teaspoons) drawn. These samples will be tested to detect the percentage of cells that have biotin labels. These visits may be every 2 weeks, 4 weeks, or some other interval. Participants will continue this schedule for up to 20 weeks or until biotin can no longer be detected....
Primary Outcome
Enumeration of biotin-labeled RBCS (BioRBCs) will be performed by flow cytometry. F-cell and/or S-cell measurement will be done by flow cytometry. BioRBCs will be isolated from post-infusion blood samples using flow cytometry separation. The collected BioRBCs and the whole blood fraction will be analyzed by high performance liquid chromatography (HPLC) for hemoglobin content.
Conditions Studied
Interventions
- BIOLOGICAL Biotin-labeled red blood cells
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-05-17 |
| Est. Completion | 2029-06-15 |
| Phase | Early Phase 1 |
What NCT06313398 shows while recruiting
NCT06313398 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (66% lower).
The record links to 3 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which Biotin-labeled red blood cells is the first listed.
NCT06313398 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06313398 about?
NCT06313398 is a clinical study titled "Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling". Background: Sickle cell disease (SCD) is an inherited disorder of the blood. SCD causes red blood cells (RBCs) to die early. This can lead to a shortage of healthy cells. SCD and other blood disorders can be managed with drugs or cured with a bone marrow transplant. Researchers want to know how lon...
What is the current status of trial NCT06313398?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 100 participants. The study started on 2024-05-17. Estimated completion is 2029-06-15.
What conditions does trial NCT06313398 study?
This clinical trial studies the following conditions: Sickle Cell Disease, Thalassemia, Hemoglobinopathy.
What interventions are being tested in trial NCT06313398?
The interventions under investigation include: Biotin-labeled red blood cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT06313398?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06313398 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06313398's enrollment target sits among peer trials
100 60th of 213 higher than 150 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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