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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months at month 12

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

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I can take pills and follow a treatment plan.

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I have been diagnosed with Sickle Cell Anemia through a blood test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months at month 12

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Primary Stroke Risk

Prevalence of Elevated TCD

Secondary outcome measures

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

Diarrhoea

Arthralgia

Vertigo

Asthenia

Epistaxis

Anaemia

Chest pain

Upper respiratory tract infection

Urinary tract infection

Ischaemic stroke

Nasopharyngitis

Pharyngitis

Cerebral infarction

Neurological decompensation

Vasculitis cerebral

Left ventricular failure

Sepsis

Aphasia

Bladder cancer

Respiratory distress

Type 2 diabetes mellitus

Ovarian cyst

Adenoid cystic carcinoma

Pulmonary embolism

Crohn's disease

Tachycardia

Laryngitis

Upper gastrointestinal haemorrhage

Sudden death

Ear infection

Leukopenia

Hypertensive crisis

Peripheral artery thrombosis

Iron deficiency anaemia

Angina unstable

Traumatic haematoma

Hyperglycaemia

100%

80%

60%

40%

20%

Study treatment Arm

Anagrelide

Hydroxyurea

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

~3620

0 / 2Eligibility criteria met