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Prevention study for Sickle Cell Disease
Official title Stroke Prevention in Nigeria 2 Trial
ClinicalTrials.gov ID: NCT06526117
What this study is testing
What is Hydroxyurea?
Hydroxyurea is an investigational medicine, given as an once-daily, being studied as a potential treatment for sickle cell disease.
Also referred to as Hydrea.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary goal of this study is to complete a multicenter single-arm, type I hybrid trial to assess the effectiveness of hydroxyurea therapy for primary stroke prevention in high-risk children with sickle cell anemia (SCA) living in Nigeria in routine care settings.
- Phase 4: studies an already-approved treatment
- 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 5 to 12
You may be able to join if
- The for the SPRING-2 Trial will consist of:
- Diagnosis of HbSS or HbSB0 confirmed by high-performance liquid chromatography (HPLC);
- Informed consent from the parent/legal guardian and assent from the patient at least 7 years of age;
- Two TCD flow velocity readings of \>or equal to180 cm/sec and \ or equal to 220 cm/sec; typically the repeat TCD is performed on the same day so...
- Age between 5 and 12 years (assessment can take place up until the 13th birthday), which includes the peak age of onset of strokes in SCA, \~ 6 yo...
You likely can't join if
- The exclusion criteria will be the following:
- Prior stroke or TIA by history, or concern for moderate or severe neurological deficit based on a positive validated "10 questions" screening;
- Other significant organ system dysfunction or other contraindication to hydroxyurea;
- Children who are already on therapy with either blood transfusion or hydroxyurea therapy;
- Significant cytopenias (absolute neutrophil count (ANC) \ 9 g/dl], renal insufficiency (creatinine \> 0.8 mg/dl); and
- History of seizures or diagnosis of epilepsy, and 6) metal in the body that would make MRI unsafe. The rationale for excluding children under 5 years...
See the full eligibility criteria
- The for the SPRING-2 Trial will consist of:
- Diagnosis of HbSS or HbSB0 confirmed by high-performance liquid chromatography (HPLC);
- Informed consent from the parent/legal guardian and assent from the patient at least 7 years of age;
- Two TCD flow velocity readings of \>or equal to180 cm/sec and \ or equal to 220 cm/sec; typically the repeat TCD is performed on the same day so treatment can start immediately;
- Age between 5 and 12 years (assessment can take place up until the 13th birthday), which includes the peak age of onset of strokes in SCA, \~ 6 yo; and
- Ability to swallow the hydroxyurea capsule.
- The exclusion criteria will be the following:
- Prior stroke or TIA by history, or concern for moderate or severe neurological deficit based on a positive validated "10 questions" screening;
- Other significant organ system dysfunction or other contraindication to hydroxyurea;
- Children who are already on therapy with either blood transfusion or hydroxyurea therapy;
- Significant cytopenias (absolute neutrophil count (ANC) \ 9 g/dl], renal insufficiency (creatinine \> 0.8 mg/dl); and
- History of seizures or diagnosis of epilepsy, and 6) metal in the body that would make MRI unsafe. The rationale for excluding children under 5 years old: Despite being a vulnerable age group for strokes, children...
The study team makes the final eligibility decision.
Where it's taking place
- Kano, Nigeria
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kano, Nigeria. 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.