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 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.
- 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
- (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.
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
- (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. (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.
- 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's taking place
- 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 - 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?
Study sites include Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.