Using Hydroxyurea to Treat Sickle Cell Anemia in Children in Africa

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of hydroxyurea in treating sickle cell anemia in children aged 6 months to 12 years in Luanda, Angola. The study aims to implement a precision medicine approach by utilizing individualized dosing calculations and limited laboratory monitoring to improve treatment accessibility. By establishing evidence-based guidelines for hydroxyurea use in sub-Saharan Africa, the trial seeks to enhance the standard of care for children suffering from this condition. The trial will involve 400 participants and aims to address the barriers to hydroxyurea utilization in low-resource settings.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of sickle cell anemia (HbSS or HbS/B0-thalassemia)
* Age 6 months- 12 years of age at enrollment
* Parent or guardian willing and able to provide written or informed consent
* Weight ≥ 7.5 kg (temporary exclusion)

Exclusion Criteria:

* Splenomegaly with evidence of hypersplenism as defined by platelet count \<150,000, hemoglobin \<5 g/dL or absolute neutrophil count \<1.0 x10\^9/L
* Hydroxyurea use within the past 6 months
* Blood transfusion within the past 6 months (temporary exclusion)
* Pregnancy
* Pre-existing severe hematologic toxicity, as defined by platelet count \<80,000, hemoglobin \<4 regardless of ANC; hemoglobin \<6 AND ARC \<100; hemoglobin \<7 AND ARC \<80 x10\^9/L (temporary exclusion)

Where it's running

• Hospital Geral dos Cajueiros
  Luanda, Angola Recruiting

Study contacts

• Principal investigator: Patrick T McGann, MD, MS — Rhode Island Hospital and Hasbro Children's Hospital
• Study coordinator: BrUOG
• Email: BrUOG@brown.edu
• Phone: 401-863-3000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Optimizing Hydroxyurea in Children with Sickle Cell in Africa

  This study tests whether raising hydroxyurea to a maximum tolerated dose is safe and beneficial for Ugandan children with sickle cell anemia already taking a fixed daily dose.

  Recruiting Phase 1/2 Children's Hospital Medical Center, Cincinnati · Kampala · NCT07708714

• Cerebrovascular Reactivity Testing with HD-DOT in Sickle Cell Patients

  This study tests whether high-density diffuse optical tomography can measure brain blood flow and oxygen use in people with sickle cell disease, to see how these signals relate to stroke risk.

  Recruiting Washington University School of Medicine · St Louis, Missouri · NCT07776444

• Adapting and testing PEN-Plus in Zambian primary care

  Aiming to see if the PEN-Plus package can be adapted and used in two Zambian hospitals to better manage chronic diseases like heart disease, diabetes, hypertension, and sickle cell in primary care.

  Recruiting Centre for Infectious Disease Research in Zambia · Lusaka, Lusaka Province · NCT07753681

• Newborn Sickle Cell Screening in Mozambique

  We’re testing a three-part plan to help babies in Mozambique get diagnosed early for sickle cell disease and start care quickly.

  Recruiting St. Jude Children's Research Hospital · Nhamatanda, Sofala · NCT07719972

• Hematopoietic stem cell editing to treat sickle cell disease

  This study tests whether a patient’s own blood stem cells can be edited to remove the sickle cell triggering gene and then returned to the patient.

  Recruiting Phase 1 Boston Children's Hospital · Boston, Massachusetts · NCT07708350

• Virtual reality options to help with VOC pain in adults with SCD

  This study tests whether headset-based virtual reality can help reduce pain for adults with sickle cell disease during vaso-occlusive crises treated in an infusion center.

  Recruiting University of Maryland, Baltimore · Baltimore, Maryland · NCT07674277

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.