Early Phase 1 Sickle Cell Disease Trial, Recruiting NCT06313398 Sponsor: National Heart, Lung, and Blood Institute (NHLBI) Condition: Sickle Cell Disease
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Early Phase 1 Sickle Cell Disease Trial, Recruiting

NCT06313398
Recruiting Early Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 or older who have a confirmed diagnosis of sickle cell disease (any type), thalassemia (alpha or beta), or another inherited blood disorder affecting haemoglobin
  • People whose blood disorder is currently stable, or who have previously had a bone marrow transplant, as shown in their medical history
  • People who are willing and able to have blood samples taken
  • People who are willing to follow all study procedures for the full duration of the trial
  • People who are able to sign and date a consent form agreeing to take part
  • Women who could become pregnant must agree to use an approved form of contraception (such as the pill, an IUD, a barrier method with spermicide, or a contraceptive implant or injection) from the start of screening until at least 4 months after the infusion
  • People who agree to follow any lifestyle guidelines set out by the study for its duration

Who may not be able to join:

  • People who have consumed biotin supplements or raw eggs in the last 30 days
  • People who have lost more than 540 mL of blood in the past 8 weeks
  • People who have received a red blood cell transfusion for their sickle cell disease or thalassemia in the last 3 months (the trial site may consider eligibility again after 3 months have passed since the last transfusion)
  • People who are currently on haemodialysis (kidney dialysis)
  • People who are pregnant or breastfeeding, or fertile women who are not using adequate contraception
  • People under the age of 18
  • People with a known allergy to biotin, due to the risk of a serious allergic reaction
  • People currently diagnosed with any form of cancer (blood cancer or solid tumour)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: John F Tisdale, M.D., National Heart, Lung, and Blood Institute (NHLBI)

Phone: (301) 529-7863

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Early Phase 1
Registry
ClinicalTrials.gov
Start date
17 May 2024
Est. completion
1 May 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To determine and compare red blood cell survival, by virtue of the mean number of days of detectable biotin-labeled RBCs, in participants with SCD and/or other hemoglobinopathies.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov