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Search / Trial NCT02286154

Therapeutic Response Evaluation and Adherence Trial (TREAT)

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Nov 5, 2014

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Hydroxyurea Sickle Cell Pharmacokinetics Dynamics Genomics

ClinConnect Summary

The Therapeutic Response Evaluation and Adherence Trial (TREAT) is a study looking at the effects of a medication called hydroxyurea for children with sickle cell anemia, a condition that affects the blood and can cause pain and other health issues. The study aims to find out the best dose of hydroxyurea that kids can tolerate, how well they are taking the medication, and how it affects their overall health and quality of life over time. Researchers will also be looking at specific biological markers in urine to help understand if patients are following their treatment plan.

To be eligible for this trial, children aged between 6 months and 21 years who have been diagnosed with sickle cell anemia can participate, as long as their doctors and families agree that starting hydroxyurea is the right choice for them. Participants will be closely monitored throughout the study, and their progress will be tracked to see how well the treatment is working. This trial is currently recruiting, and it’s a great opportunity for families looking for options to manage sickle cell anemia more effectively.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Diagnosis of sickle cell anemia (HbSS or Hbβ0-thalassemia)
  • 2. Age 6 months to 21 years at the time of enrollment
  • 3. Clinical decision by patient, family, and healthcare provider to initiate hydroxyurea therapy, including patients who are transitioning from chronic transfusions to hydroxyurea therapy
  • Exclusion Criteria:
  • 1. Family unwillingness to sign informed consent or comply with study treatments

About Children's Hospital Medical Center, Cincinnati

Children's Hospital Medical Center in Cincinnati is a leading pediatric healthcare institution dedicated to advancing child health through innovative clinical research and comprehensive patient care. Renowned for its commitment to excellence, the center conducts a wide range of clinical trials aimed at developing and evaluating new treatments and therapies for pediatric populations. With a focus on multidisciplinary collaboration and ethical research practices, Children's Hospital Medical Center strives to improve health outcomes for children while contributing to the broader scientific understanding of pediatric medicine.

Locations

Cincinnati, Ohio, United States

Cincinnati, Ohio, United States

Patients applied

0 patients applied

Trial Officials

Charles Quinn, MD, MS

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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