NCT06313398ToborozKorai 1. fázis
Determination of Red Cell Survival in Sickle Cell Disease and Other Hemoglobinopathies Using Biotin Labeling
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 28.
Rövid összefoglaló (regiszter, angolul)
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....
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- Korai 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 100 (tervezett)
- Első benyújtás
- 2024. márc. 14.
- Kezdés
- 2024. máj. 17.
- Elsődleges befejezés
- 2029. máj. 1.
- Fő szponzor
- National Heart, Lung, and Blood Institute (NHLBI)
- Betegségek
- Sarlósejtes vérszegénység, Thalassaemia
- NCT-szám
- NCT06313398
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · Korai 1. fázis
- Tervezett résztvevők: 100
- 2024. máj. 17. és az elsődleges befejezés (2029. máj. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Blood loss within the previous 8 weeks (\>540 mL).
Más betegség
- Known allergic reactions to biotin, due to risk of possible life-threatening allergic reaction.
- Current diagnosis of malignancy (liquid and/or solid).
Egyéb
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Consumption of biotin supplements or raw eggs within the last 30 days.
- Red cell transfusion for their underlying SCD and/or thalassemia within the last 3 months.
- Participants may be eligible after three months following their last transfusion.
- Patients on hemodialysis, due to possibility of early removal of biotinylated RBCs.
- Pregnancy, lactation or absence of adequate contraception for fertile female subjects.
- Pediatric subjects will not participate in this study.
A regiszterben nem jelölt feltételek
- INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 years or greater with confirmed diagnosis of SCD (all genotypes), thalassemia (beta and/or alpha), or other inherited hemoglobinopathy not otherwise specified.
- Be at steady state for their underlying disease (e.g. SCD or thalassemia) or post-bone marrow transplantation status, as evidenced by medical history.
- Ability to have blood samples drawn.
- For female participants of child-bearing potential, agree to use birth control during study participation. Female subjects of child-bearing potential must agree to use a medically acceptable method of birth control such as an oral contraceptive, intrauterine device, barrier and spermicide, or contraceptive implant/injection from start of screening through 4 months after infusion.
- Agreement to adhere to Lifestyle Considerations throughout study duration
Életkor a regiszterben: 18 év – 100 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| National Institutes of Health Clinical Center Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Bethesda | Egyesült Államok | Toboroz |
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