Clinical trial for Sickle Cell Disease (SCD)
Official title Optimizing Hydroxyurea Dosage With Pharmakokinetic in Patients Suffering of Moderate to Severe Sickle Cell Anemia
ClinicalTrials.gov ID: NCT06761560
What this study is testing
- What it's testing
- The study wants to see whether using pharmacokinetic blood tests helps patients reach a safe, effective hydroxyurea dose faster than the usual bloodwork schedule.
- Who it's for
- It is looking for adults with moderate to severe sickle cell anemia who are already taking hydroxyurea.
- What's involved
- Participants will be randomly assigned to two groups: one will have their dose adjusted based on pharmacokinetic tests, the other on standard bloodwork. A third group of long‑term users will have a single pharmacokinetic test to check drug levels.
- Time commitment
- The study lasts 12 months, with regular clinic visits and blood tests as scheduled for each group.
- Phase 3: a large, late-stage study
- Time commitment: about 12 months
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18
You may be able to join if
- 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 had confirmed diagnosis of SCD at CHU Sainte-Justine biochemistry lab with hemoglobin electrophoresis.
You likely can't join if
- 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
See the full eligibility criteria
- 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 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.