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NCT04476277 · ClinicalTrials.gov registry record · Early Phase 1
Red Cell Half Life Determination in Patients With and Without Sickle Cell Disease
A Early Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 22
- Enrollment target
NCT04476277 is a Early Phase 1 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 22 participants.
The verdict
NCT04476277, a Early Phase 1 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
Background: Sickle cell disease (SCD) is an inherited blood disorder. It results from a single genetic change (mutation) in red blood cells (RBCs). RBCs are the cells that carry oxygen to the body. In people with SCD, some RBCs are abnormal and die early. This leaves a shortage of healthy RBCs. Researchers want to learn more about how long RBCs live in the human body. Objective: To study how long RBCs live in people with and without SCD. Eligibility: People age 18 and older who either have SCD, had SCD but were cured with a bone marrow transplant, have the sickle cell trait (SCT), or are a healthy volunteer without SCD or SCT Design: Participants will be screened with a medical history and physical exam. They will give a blood sample. Participants will have a small amount of blood drawn from a vein. In the laboratory, the blood will be mixed with a vitamin called biotin. Biotin sticks to the outside of RBCs without changing their function, shape, or overall lifetime. This process is known as biotin labeling of RBCs. The biotin labeled RBCs will be returned to the participant via vein injection. Participants will give frequent blood samples. Their RBCs will be studied to see how many biotin labeled RBCs remain over time. This shows how long the RBCs live. Participants will give blood samples until no biotin labeled RBCs can be detected. During the study visits, participants will report any major changes to their health. Participation lasts for up to 6 months.
Interventions
- DRUG Biotin label
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2021-04-19 |
| Est. Completion | 2023-02-14 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04476277
The ClinicalTrials.gov registry entry for NCT04476277 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Biotin label is the first listed.
NCT04476277 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04476277 about?
NCT04476277 is a clinical study titled "Red Cell Half Life Determination in Patients With and Without Sickle Cell Disease". Background: Sickle cell disease (SCD) is an inherited blood disorder. It results from a single genetic change (mutation) in red blood cells (RBCs). RBCs are the cells that carry oxygen to the body. In people with SCD, some RBCs are abnormal and die early. This leaves a shortage of healthy RBCs. Res...
What is the current status of trial NCT04476277?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 22 participants. The study started on 2021-04-19. Estimated completion is 2023-02-14.
What interventions are being tested in trial NCT04476277?
The interventions under investigation include: Biotin label (DRUG).
Who is sponsoring clinical trial NCT04476277?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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