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Could a tailored drug dose cut transfusions for kids with sickle cell?

NCT ID NCT05662098

Disease control Sponsor: Children's Hospital Medical Center, Cincinnati Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving children with sickle cell anemia a personalized dose of hydroxyurea can lower their need for blood transfusions. About 100 children in Uganda will receive a dose based on their own drug levels. Researchers will compare transfusion rates before and during treatment to see if the approach works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hydroxyurea
What this could lead to
If successful, this could show that personalized hydroxyurea dosing reduces the need for blood transfusions in children with sickle cell anemia.
What could go wrong
This is a very early, small study (100 children) without a comparison group, so results may not be conclusive or apply broadly. Hydroxyurea can lower blood counts and cause other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2022

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 months to 10 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with documented HbSS disease * Age: ≥ 12 months and ≤ 10 years of age, at the time of enrollment * Parent or guardian willing and able to provide informed consent * Able to comply with all study related treatments, evaluations, and follow-up Exclusion Criteria: * Current hydroxyurea treatment (or within the past 6 months) * Regular blood transfusions (6 or more within the past 12 months) * Transfusion within the last 30 days (temporary exclusion) * Known malignancy or other known chronic illnesses including but not limited to active tuberculosis, renal disease * Current participation in other therapeutic clinical trials, or within 6 months of prior disease-modifying treatments

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Conditions

The condition(s) this trial relates to.

sickle cell disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Sickle cell disease

Contacts and locations

Locations

  • Jinja Regional Referral Hospital (JRRH), Department of Paediatrics, Sickle Cell Clinic

    Jinja, Uganda

More trials for these conditions

Other studies related to the condition(s) this trial covers.