NIH-funded research U01 cooperative agreement

Hydroxyurea treatment for young children with sickle cell anemia in Africa

Official title: Realizing Effectiveness Across Continents with Hydroxyurea(REACH): A Phase I/II Pilot Study of Hyroxyurea for Children with Sickle Cell Anemia

Funded at Cincinnati Childrens Hosp Med Ctr · NIH-11399208 · Data updated 2026-11-12

Giving hydroxyurea to young children with sickle cell anemia in several African countries to reduce sickle-related problems while monitoring safety.

More Anemia research and trials

Quick facts

Grant typeU01 cooperative agreement
Study typeNIH-funded research
Funding institutionCincinnati Childrens Hosp Med Ctr
NIH-funded
Lab location1 site (Cincinnati, United States)
Project startAugust 1, 2017
Project endJuly 31, 2027
Funding year2025
Award (this year)$244,008
NIH project number3U01HL133883-09S2
Project IDNIH-11399208 on NIH RePORTER

Who could benefit from this research

Could help

Young children (infants through about 11 years old) with confirmed sickle cell anemia who can attend one of the participating clinics in the listed African countries are the typical candidates.

Less likely to help

Children without sickle cell anemia, adults, or patients with medical conditions that make hydroxyurea unsafe (for example, severe bone marrow failure or uncontrolled infections) would not be expected to benefit from this protocol.

What this research studies

This project treated over 600 children with sickle cell anemia in Angola, the Democratic Republic of Congo, Kenya, and Uganda, starting in early childhood and increasing the dose to each child’s maximum tolerated level. Children had regular clinic visits for blood tests, safety checks, and tracking of pain episodes, hospital visits, and other sickle-related events. The work included newborn screening to identify affected infants and used standardized rules to guide dose changes and manage side effects. Local clinical teams collected long-term outcome data in routine care settings to show whether hydroxyurea is feasible and beneficial in these low-resource environments.

Why it matters

Potential benefit: If successful, this work could lower pain crises, hospitalizations, and early deaths from sickle cell anemia in African children and support wider safe use of hydroxyurea there.

How similar studies have gone: Hydroxyurea has a strong record of safety and benefit in children with sickle cell anemia in high-income countries, and this project applied and documented that approach in African settings.

Where this research is happening

  • Cincinnati Childrens Hosp Med Ctr
    Cincinnati, United States
    Active

Researchers

  • Principal investigator: Ware, Russell E — Cincinnati Childrens Hosp Med Ctr
  • Study coordinator: Ware, Russell E

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.