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RECRUITING
NCT07177300
PHASE4

Effectiveness of Nontraditional Hydroxyurea Algorithms: Novel and Clinical Evaluations (ENHANCE)

Sponsor: Children's Hospital Medical Center, Cincinnati

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

6 Months - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2024-12-19

Completion Date

2028-12

Last Updated

2025-09-16

Healthy Volunteers

No

Interventions

DRUG

PK-optimized oral hydroxyurea at MTD until 15 years of age.

Because people are different, we will measure how each participant's body absorbs and eliminates the medicine, hydroxyurea, using blood tests. This information will be used to determine the best dose for each participant (rather than using the same weight-based dose for everyone).

Locations (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States