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Anti-metabolites

Hydroxyurea for Sickle Cell Anemia

Phase 2
Waitlist Available
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to take oral medication and follow hydroxyurea treatment schedule
Confirmed diagnosis of Sickle Cell Anemia (SCA) by haemoglobin electrophoresis
Must not have
Previous history of stroke
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months at month 12
Awards & highlights
No Placebo-Only Group

Summary

This trial looks into how Sickle Cell Anemia affects the brain in Tanzanian children, and its effects on stroke risk with hydroxyurea therapy.

Who is the study for?
The SPHERE trial is for children in Tanzania with Sickle Cell Anemia who can attend study visits, stay near the study center, and take oral medication. They must have a confirmed diagnosis of SCA and be willing to follow the treatment schedule. Exclusions include recent illness, hospitalization or transfusion, certain abnormal lab values, pregnancy or lactation, known allergies to hydroxyurea components, or previous stroke.
What is being tested?
This trial aims to find out how common elevated TCD velocities are among Tanzanian children with SCA and see if hydroxyurea therapy can reduce these velocities and lower primary stroke risk. It involves initial TCD screening followed by longitudinal data collection on TCD velocities after starting hydroxyurea treatment.
What are the potential side effects?
Hydroxyurea may cause side effects such as bone marrow suppression (which affects blood cell counts), digestive issues like nausea or constipation, skin changes like rashes or ulcers, headache, dizziness, feverishness and potential long-term risks including increased chance of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can take pills and follow a treatment plan.
Select...
I have been diagnosed with Sickle Cell Anemia through a blood test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a stroke before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months at month 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months at month 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Primary Stroke Risk
Prevalence of Elevated TCD
Secondary study objectives
Change in Hemoglobin Concentration
Effect of Splenomegaly and Malaria Infections
Hydroxyurea Area Under the Curve (AUC)
+3 more

Side effects data

From 2015 Phase 4 trial • 150 Patients • NCT00202644
25%
Headache
24%
Palpitations
12%
Hypertension
8%
Diarrhoea
8%
Arthralgia
7%
Vertigo
7%
Asthenia
5%
Epistaxis
5%
Anaemia
5%
Chest pain
5%
Upper respiratory tract infection
5%
Urinary tract infection
4%
Ischaemic stroke
3%
Nasopharyngitis
3%
Pharyngitis
1%
Crohn's disease
1%
Respiratory distress
1%
Bladder cancer
1%
Laryngitis
1%
Sepsis
1%
Neurological decompensation
1%
Pulmonary embolism
1%
Vasculitis cerebral
1%
Tachycardia
1%
Aphasia
1%
Cerebral infarction
1%
Type 2 diabetes mellitus
1%
Adenoid cystic carcinoma
1%
Left ventricular failure
1%
Ovarian cyst
1%
Upper gastrointestinal haemorrhage
1%
Sudden death
1%
Ear infection
1%
Leukopenia
1%
Hypertensive crisis
1%
Peripheral artery thrombosis
1%
Iron deficiency anaemia
1%
Angina unstable
1%
Traumatic haematoma
1%
Hyperglycaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anagrelide
Hydroxyurea

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Normal Initial Screening TCDExperimental Treatment1 Intervention
Those who are found to have a normal TCD at enrolment are a part of the observation/control cohort and will undergo repeat TCD every 12 months after enrolment. If the TCD at 12 months has changed to an elevated velocity (conditional or abnormal), the study participant will be reassigned to the elevated initial screening TCD arm and can begin study treatment (hydroxyurea), but will not be included in the primary endpoint analysis.
Group II: Elevated Initial Screening TCDExperimental Treatment2 Interventions
Those who have an elevated initial screening TCD (either conditional or abnormal TAMV) and will be a treatment cohort that receives open-label hydroxyurea therapy as per the dosing and administration schedule.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxyurea
2006
Completed Phase 4
~3490

Find a Location

Who is running the clinical trial?

The American Society of HematologyUNKNOWN
Children's Hospital Medical Center, CincinnatiLead Sponsor
836 Previous Clinical Trials
6,565,105 Total Patients Enrolled
Bugando Medical CentreUNKNOWN

Media Library

Hydroxyurea (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT03948867 — Phase 2
Sickle Cell Disease Research Study Groups: Normal Initial Screening TCD, Elevated Initial Screening TCD
Sickle Cell Disease Clinical Trial 2023: Hydroxyurea Highlights & Side Effects. Trial Name: NCT03948867 — Phase 2
Hydroxyurea (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03948867 — Phase 2
~11 spots leftby Mar 2025
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