Testing higher hydroxyurea doses for children with sickle cell anemia in malaria areas
Tests hydroxyurea at higher doses in children with sickle cell anemia.
Plain-language title generated from the registry record
Registry title: Optimizing Hydroxyurea Therapy in Children With Sickle Cell Anemia In Malaria Endemic Areas: The NOHARM Maximum Tolerated Dose (MTD) Study
Key facts
- Where
- Kampala, UgandaSee the site
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adolescents with confirmed sickle cell anemia, aged 11 to 18, in Kampala and nearby districts. They either already take part in the NOHARM MTD study or are in an untreated comparison group.
- Age
- 11 to 18 years
- Sex
- All sexes can join.
- Disease stage
- Confirmed sickle cell anemia (SCA).
- Earlier treatment
- One group must already be in the NOHARM MTD study of hydroxyurea. The comparison group must never have had hydroxyurea.
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 11 and 18 years old?
Source: NCT07708714, who can take part
Where in Uganda
- Mulago Hospital Sickle Cell ClinicKampala, UgandaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Children's Hospital Medical Center, Cincinnati
- Trial code
- NCT07708714
- Record updated
- 16 July 2026
- Original description
NOHARM MTD is an extension of a previous study for children with Sickle Cell Anemia (SCA) who were enrolled in the NOHARM study. All children enrolled in NOHARM received hydroxyurea treatment at a fixed daily dose of 20 mg/kg/day. This dose was selected as a likely safe dose, but does not escalate hydroxyurea to maximum tolerated dose "MTD" as is commonly done in the US. Without this information, we cannot know whether hydroxyurea treatment at the MTD would be feasible (since it requires closer monitoring to avoid hematological toxicities), safe (since adverse events may be greater with MTD, risk of malaria may be altered by MTD, and risk of infections as a result of neutropenia could also be greater with MTD) or beneficial (MTD is associated with higher hemoglobin and fetal hemoglobin concentration).Read full original descriptionShow less
Optimizing Hydroxyurea Therapy in Children With Sickle Cell Anemia In Malaria Endemic Areas: The NOHARM Maximum Tolerated Dose (MTD) Study
NOHARM MTD is an extension of a previous study for children with Sickle Cell Anemia (SCA) who were enrolled in the NOHARM study. All children enrolled in NOHARM received hydroxyurea treatment at a fixed daily dose of 20 mg/kg/day. This dose was selected as a likely safe dose, but does not escalate hydroxyurea to maximum tolerated dose "MTD" as is commonly done in the US. Without this information, we cannot know whether hydroxyurea treatment at the MTD would be feasible (since it requires closer monitoring to avoid hematological toxicities), safe (since adverse events may be greater with MTD, risk of malaria may be altered by MTD, and risk of infections as a result of neutropenia could also be greater with MTD) or beneficial (MTD is associated with higher hemoglobin and fetal hemoglobin concentration).
Adolescents with confirmed SCA who are currently enrolled in the NOHARM MTD Study of hydroxyurea at the Mulago Hospital Sickle Cell Clinic (MHSCC), will be eligible for the NOHARM MTD LT version 2.0 extension study after completing re-consent. An age-matched untreated (hydroxyurea-naïve) group of adolescents will also be enrolled as a Comparator Cohort. This will comprise 75 children from Kampala and surrounding districts, ages 11 - 18 years of age, with confirmed SCA.