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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Cincinnati Children's Hospital Medical Center
RECRUITING
Cincinnati
Contact Information
Primary
Wendi L. Long, Sr. Regulatory Specialist, BS, CCRC
wendi.long@cchmc.org
513-803-3064
Backup
Teresa Latham, Research Director, DrPH
teresa.latham@cchmc.org
(513) 803-7922
Time Frame
Start Date: 2024-12-19
Estimated Completion Date: 2028-12
Participants
Target number of participants: 50
Treatments
Experimental: Observational Treatment Group (Single Arm)
All children with sickle cell anemia who are started on hydroxyurea for clinical indicators between 6 months and 5 years of age can do so on this observational study with PK-optimized hydroxyurea dosing.
Sponsors
Leads: Children's Hospital Medical Center, Cincinnati
Collaborators: Greater Cincinnati Foundation

This content was sourced from clinicaltrials.gov