Phase 3 Sickle Cell Disease Trial, Recruiting NCT05285917 Sponsor: Brown University Condition: Sickle Cell Disease
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Phase 3 Sickle Cell Disease Trial, Recruiting

NCT05285917
Recruiting Phase 3

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 diagnosed with sickle cell anemia (specifically the HbSS or HbS/B0-thalassemia types)
  • Children between 6 months and 12 years old at the time of enrollment
  • Children whose parent or guardian is willing and able to provide written consent on their behalf
  • Children who weigh at least 7.5 kg (this restriction may be temporary — confirm with trial site)

Who may not be able to join:

  • Children with an enlarged spleen that is affecting blood cell counts, specifically those with a platelet count below 150,000, hemoglobin below 5 g/dL, or a very low white blood cell count
  • Children who have used the medication hydroxyurea within the past 6 months
  • Children who have received a blood transfusion within the past 6 months (this restriction may be temporary — confirm with trial site)
  • Children who are pregnant
  • Children with already serious problems with their blood counts, based on specific combinations of low hemoglobin, low platelet count, or low reticulocyte (young red blood cell) count, as assessed by a doctor (this restriction may be temporary — confirm with trial site)

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
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Patrick T McGann, MD, MS, Rhode Island Hospital and Hasbro Children's Hospital

Phone: 401-863-3000

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
Phase 3
Sponsor
Brown University
Registry
ClinicalTrials.gov
Start date
15 November 2023
Est. completion
1 September 2026

Where this trial is recruiting

Angola

Primary endpoints

Rate of clinical, sickle cell adverse events (grade ≥ 3) as assessed by CTCAE v5.0; Number of non-SCA related adverse events (grade ≥3), including death as assessed by CTCAE v5.0

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