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NCT06761560 · ClinicalTrials.gov record · last posted 2026-08-21

Optimizing Hydroxyurea Dosage With Pharmakokinetic in Patients Suffering of Moderate to Severe Sickle Cell Anemia

Study acronym: OPTIMA
StatusRecruiting
PhasePhase 2/3
Started2026-02-03
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from the ClinicalTrials.gov record
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.

Protocol amendment history 3 changes detected by DataLookout

2026-08-22
notable
Recruitment opened
2026-08-22
critical
Primary completion pushed: 2027-11-25 → 2028-11-25
2026-08-22
minor
Completion pushed: 2027-11-25 → 2028-11-25
Trial Details
NCT Number NCT06761560
Lead Sponsor Yves Pastore
Collaborators: St. Justine's Hospital
Conditions Sickle Cell Disease (SCD)
Enrollment 29 participants
Start Date 2026-02-03
Primary Completion 2028-11-25 (estimated)
Study Completion 2028-11-25 (estimated)
Updated on ClinicalTrials.gov 2026-08-21