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Could a common drug ease sickle cell pain for african children?

NCT ID NCT01966731

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests whether hydroxyurea, a drug already used for sickle cell disease in other parts of the world, is safe and effective for children with sickle cell anemia in Africa. Children aged 1 to 10 years receive daily doses of hydroxyurea, with careful monitoring for side effects and improvements in blood counts and pain crises. The goal is to gather evidence that could make this treatment more accessible across the continent.

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 episodes and hospital visits.
What could go wrong
This is an early-phase study, so the full benefits and risks are not yet known. Hydroxyurea can lower blood cell counts, requiring careful monitoring.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

635 people

The number who actually took part.

Start date

Jun 2014

Expected to finish

Aug 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

1 year 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. Age range of 1.00-9.99 years, inclusive, at the time of enrollment 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, as defined in Appendix I) 3. Pre-existing severe hematological toxicity (temporary exclusions) 1. Anemia: Hb \<4.0 gm/dL 2. Anemia: Hb \<6.0 gm/dL with ARC \<100 x 109/L 3. Reticulocytopenia: ARC \<80 x 109/L with Hb \<7.0 gm/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. Hydroxyurea use within 6 months before enrollment (temporary exclusion)

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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

  • Centre Hospitalier Monkole

    Kinshasa, Democratic Republic of the Congo

  • Hospital Pediátrico David Bernardino

    Luanda, Angola

  • KEMRI/Wellcome Trust Research

    Kilifi, Kenya

  • Ministry of Health Mbale Regional Hospital

    Mbale, Uganda

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