NCT06761560RecruitingPhase 2/3
Optimizing Hydroxyurea Dosage With Pharmakokinetic in Patients Suffering of Moderate to Severe Sickle Cell Anemia
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
The goal of this study is to evaluate if patients with sickle cell disease can achieve a maximum tolerate dose of hydroxuyrea (HU) over a period of 12 months faster with pharmacokinetic testing than the standard of care bloodwork follow-up. Pharmacokinetic test is used to evaluate the process by which drugs are absorbed, distributed in the body, localized in the tissues, and is excreted. Patient will be a randomized (coin toss method) into 2 groups. Group A will have an increase of their HU dosage with pharmacokinetic results and Group B will have an increase of their HU dosage following the standard of care bloodwork follow-up. Group C will include patient with sickle cell disease that has been taking HU for at least 12 months and will undergo a pharmacokinetic dosage to check the level of HU only one time.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 29 (estimated)
- First submitted
- 12 Dec 2024
- Start date
- 3 Feb 2026
- Primary completion date
- 25 Nov 2028
- Lead sponsor
- Yves Pastore
- Diseases
- Sickle cell disease
- NCT number
- NCT06761560
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 29
- From 3 Feb 2026 to the primary completion date, 25 Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients have received a blood transfusion in the last 4 weeks of study enrollment.
- Have received a hematopoietic stem-cell transplantation
Other illness
- Conditions which in the opinion of the investigator, would compromise participation in the study will be excluded.
Lab values
- Creatinine \>2x normal for age
- ALT\>2x normal for age
Other
- Patients with sickle cell genotype other than SS or SBThal0 (SC, SBThal+, SE or SD)
- Patients on chronic transfusion program
- Sexually active females unwilling to comply with reliable method of birth control
- Pregnancy
Who the study is looking for
- 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.
- 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.
Age in the registry: 6 months to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Sainte-Justine Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.