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Could a cheap drug transform sickle cell care for african kids?

NCT ID NCT06171217

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests the drug hydroxyurea in 811 children with sickle cell anemia across Africa. The goal is to see if it is safe and effective, and to make it more available. Children take daily doses adjusted for their weight, and doctors monitor blood counts and fetal hemoglobin levels.

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 make hydroxyurea widely available for children with sickle cell anemia in Africa, reducing pain crises and complications.
What could go wrong
This is a phase II trial, so results are still early. Hydroxyurea can cause bone marrow suppression and may not work for all children. Long-term benefits are not yet proven.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

811 people

The number who actually took part.

Started

Oct 2023

Expected to finish

Oct 2033

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

3 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 1. Pediatric patients with documented sickle cell anemia (typically HbSS supported by hemoglobin electrophoresis, complete blood count, and peripheral blood smear) 2. In the Original Cohort, age range of 1.00-9.99 years, inclusive, at the time of enrollment (now age 5.5 - 17.5 years); age range 3.0-10.0 years for the New Cohort 3. Weight at least 10.0 kg at the time of enrollment 4. Parent or guardian willing and able to provide written informed consent, with child's verbal assent as per local IRB/Ethics Board requirements 5. Willingness to comply with all study-related treatments, evaluations, and follow-up Exclusion Criteria 1. Known medical condition making participation ill-advised (e.g., acute or chronic infectious disease, HIV, or malignancy) 2. Acute or chronic severe malnutrition determined by impaired growth parameters as defined by WHO (weight for length/height or height for age \>3 z-scores below the median WHO growth standards. 3. Pre-existing severe hematological toxicity (temporary exclusions) 1. Anemia: Hb \<4.0 g/dL 2. Anemia: Hb \<6.0 g/dL with ARC \<100 x 109/L 3. Reticulocytopenia: ARC \<80 x 109/L with Hb \<7.0 g/dL 4. Thrombocytopenia: Platelets \<80 x 109/L 5. Neutropenia: ANC \<1.0 x 109/L 4. Blood transfusion within 60 days before enrollment (temporary exclusion) 5. In the Original Cohort, hydroxyurea use within 6 months before enrollment (temporary exclusion). In the New Cohort, the children should be hydroxyurea naïve, without any prior treatment exposure.

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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.

Children Sickle cell disease

Contacts and locations

Locations

  • Centre Hospitalier Monkole

    Kinshasa, Democratic Republic of the Congo

  • Hospital Pediátrico David Bernardino

    Luanda, Angola

  • KEMRI/Wellcome Trust Research

    Kilifi, Kenya

  • Mbale Regional Hospital

    Mbale, Uganda

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