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Can a blood test find the right drug dose faster for sickle cell?

NCT ID NCT06761560

Disease control Sponsor: Yves Pastore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 21, 2026 · Last updated Aug 21, 2026

Summary

This trial asks whether using a pharmacokinetic test—which tracks how the body absorbs and processes a drug—can help children with sickle cell disease reach the best dose of hydroxyurea faster than the usual bloodwork checks. Patients are split into groups: one gets dose adjustments guided by the pharmacokinetic test, the other follows standard care. A third group, already on hydroxyurea for a year, gets a single test to check drug levels. The goal is to see if the test-based approach leads to a more effective dose sooner.

What this could mean

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

Active substance
Pharmacokinetic-based dosing of hydroxyurea
What this could lead to
If it works, this could make hydroxyurea dosing faster and more precise, helping sickle cell patients get better symptom control sooner.
What could go wrong
The trial is small and early, so results may not apply to everyone. Pharmacokinetic testing adds complexity and may not clearly beat standard 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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 29 people

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

Started

Feb 2026

Expected to finish

Nov 2028

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

6 months to 18 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 (Group A and B) : * Have had confirmed diagnosis of SCD at CHU Sainte-Justine biochemistry lab with hemoglobin electrophoresis. * Patients with SS, SBThal0. * Agree to take hydroxyurea for a period of 12 months * Be between age of 6months old and 18 years old. * Have consented for participation in the study. Inclusion Criteria (Group C) : * Have had confirmed diagnosis of SCD at CHU Sainte-Justine biochemistry lab with hemoglobin electrophoresis. * Patients with SS, SBThal0. * Have taken hydroxyurea for a period of at least 12 months, and have received HU at a stable dose and at MTD for at least 6 months. * Be between age of 6months old and 18 years old. * Have consented for participation in the study. Exclusion Criteria: * Patients with sickle cell genotype other than SS or SBThal0 (SC, SBThal+, SE or SD) * Patients on chronic transfusion program * Patients have received a blood transfusion in the last 4 weeks of study enrollment. * Have received a hematopoietic stem-cell transplantation * Creatinine \>2x normal for age * ALT\>2x normal for age * Sexually active females unwilling to comply with reliable method of birth control * Pregnancy * Conditions which in the opinion of the investigator, would compromise participation in the study will be excluded.

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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 (SCD)

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

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Contacts and locations

Locations

  • CHU Sainte-Justine

    RECRUITING

    Montreal, Quebec, H3T 1C5, Canada

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