Status:
ACTIVE_NOT_RECRUITING
Therapeutic Response Evaluation and Adherence Trial (TREAT)
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Anemia, Sickle Cell
Eligibility:
All Genders
6-21 years
Phase:
NA
Brief Summary
The primary objectives of this prospective study of hydroxyurea for children with sickle cell anemia are 1) Develop and prospectively evaluate a population pharmacokinetic/pharmacodynamics model to pr...
Detailed Description
There is now ample clinical evidence that hydroxyurea is a safe and effective medication for adults and children with sickle cell anemia (SCA), and most hematologists agree the short-term safety and e...
Eligibility Criteria
Inclusion
- Diagnosis of sickle cell anemia (HbSS or Hbβ0-thalassemia)
- Age 6 months to 21 years at the time of enrollment
- Clinical decision by patient, family, and healthcare provider to initiate hydroxyurea therapy, including patients who are transitioning from chronic transfusions to hydroxyurea therapy
Exclusion
- 1\. Family unwillingness to sign informed consent or comply with study treatments
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT02286154
Start Date
October 1 2014
End Date
December 1 2026
Last Update
July 17 2025
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229