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Early Phase 1 N=22 Basic Science

Red Cell Half Life Determination in Patients With and Without Sickle Cell Disease

Sickle Cell Disease · Sickle Cell Anemia

Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Mean Red Blood Cells Lifespan in Participants — 64.1; 113.4; 126.0; 123.7 day — p=<0.001

Study Design & Population

Study type
Interventional
Phase
Early Phase 1
Interventions
Biotin label (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Primary completion
Dec 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Mean Red Blood Cells Lifespan in Participants
64.1; 113.4; 126.0; 123.7 <0.001 sig
SECONDARY
Number of Participants With Antibody Detection
0; 0; 0; 0
SECONDARY
Mean White Blood Cell Count
9.0; 6.5 0.28
SECONDARY
Mean Red Blood Cell Count
3.0; 4.3 0.04 sig
SECONDARY
Mean Hemoglobin Value
8.8; 13.0 0.01 sig
SECONDARY
Mean Hematocrit Value
25.0; 38.3 0.01 sig
SECONDARY
Mean Value of Mean Corpuscular Volume
86.7; 89.4 0.65
SECONDARY
Mean Absolute Reticulocyte Count
192.7; 152.9 0.48
SECONDARY
Mean Aspartate Aminotransferase Value
26.1; 26.1 0.99
SECONDARY
Mean Total Bilirubin Value
7.1; 1.1 0.39
SECONDARY
Mean Lactate Dehydrogenase Value
323.9; 253.7 0.43
SECONDARY
Mean Adult Hemoglobin Percentage
2.8; 59.6 <0.01 sig
SECONDARY
Mean Sickle Hemoglobin Percentage
68.7; 36.7 0.01 sig
SECONDARY
Mean Fetal Hemoglobin Percentage
10.4; .5 0.04 sig

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.

Eligibility Criteria

INCLUSION CRITERIA

  • Age 18 or greater with a confirmed diagnosis of homozygous SCD (HbSS, HbSC, HbSB0), sickle cell trait (HbAS), or healthy volunteer (HbA)
  • Normal renal function: creatinine 540mL
  • Pregnancy
  • Pre-existing, naturally occurring antibodies against biotin
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04476277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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