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Tailoring sickle cell drug doses: a new hope for nigerian patients

NCT ID NCT07543289

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looks at how genetic differences affect the way Nigerian sickle cell patients respond to hydroxyurea, a common treatment. Researchers will monitor 100 patients to build a computer model that predicts the best dose for each person. The goal is to reduce side effects and improve outcomes like fewer pain crises.

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 lead to personalized hydroxyurea dosing guidelines for Nigerian sickle cell patients, making treatment safer and more effective.
What could go wrong
This is an early-stage observational study with only 100 participants, so results may not apply to all patients. The models need further validation before clinical use.

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.

Participants

About 100 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Mar 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.

Who is studied

The study population for this research comprises patients diagnosed with sickle cell disease (SCD) of Nigerian descent, recruited from selected clinical centres within Nigeria ( Sickle Cell Foundation, Ibadan and the Obafemi Awolowo University Teaching Hospital Complex). They will be consented SCD adult patients who have been on hydroxyurea at least six months before study commencement or who are willing to commence hydroxyurea therapy. In both instances, they will be SCD patients whose genetic profile for the major metabolising enzymes are known.

Ages

18 years and older

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 confirmed diagnosis of sickle cell disease (SCD) (e.g., HbSS, HbSC) and of Nigerian descent. * Patients currently on hydroxyurea therapy or hydroxyurea-naive patients who are willing to commence hydroxyurea therapy. * Patients whose genotypic profile for the major metabolising enzymes has been previously done e.g. CYP2D6. * Patients who consent to be part of the study Exclusion Criteria: * Patients with severe comorbidities that may significantly alter pharmacokinetics (e.g., advanced renal or hepatic failure) * Patients in acute crisis at the time of sampling. * Patients with documented poor adherence to other medications previously on. * Pregnant females and lactating mothers.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Obafemi Awolowo University Teaching Hospital Complex

    Ile-Ife, Osun State, 220282, Nigeria

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