Effectiveness of Nontraditional Hydroxyurea Algorithms: Novel and Clinical Evaluations (ENHANCE)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age6+
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
The main reason for this research study is to learn more about hydroxyurea and the treatment of sickle cell anemia (SCA). Hydroxyurea is a medication that has been studied for many years and has been shown to provide benefits for people with SCA.
In this research study, the investigators hope to learn more about how to improve the dosing and monitoring of hydroxyurea and learn more about the long-term effects of hydroxyurea over time. Hydroxyurea is usually dosed based only on your weight. Our study will use a new way to select a starting dose that is based on how each patient absorbs hydroxyurea.
Eligibility criteria
Qualifiers
Diagnosis of sickle cell anemia (HbSS) or sickle-β0-thalassemia (HbSβ0)
Age 6 months at the time of enrollment
Clinical decision by patient, family, and healthcare provider to initiate hydroxyurea therapy
Disqualifiers
Current treatment with regularly scheduled blood transfusions
Sickle-hemoglobin C disease (HbSC), sickle-β+-thalassemia (HbSβ+)
Trial design
Treatments tested in this trial
- PK-optimized oral hydroxyurea at MTD until 15 years of age.
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Children's Hospital Medical Center, Cincinnati
Lead sponsor
Greater Cincinnati Foundation
Collaborator
Source ClinicalTrials.gov