Alternative Dosing And Prevention of Transfusions (ADAPT)

Sex: All

Ages: 12 Months – 10 Years

Phase: EARLY_PHASE1

Enrollment: 100

Sponsor: Children's Hospital Medical Center, Cincinnati

Summary

ADAPT is a prospective cohort study at Jinja Regional Referral Hospital (JRRH) primarily to assess the effect of hydroxyurea on blood transfusion utilization and secondarily to determine the feasibility of PK-guided hydroxyurea dosing.

Eligibility Criteria

Inclusion Criteria:Patients with documented HbSS diseaseAge: ≥ 12 months and ≤ 10 years of age, at the time of enrollmentParent or guardian willing and able to provide informed consentAble to comply with all study related treatments, evaluations, and follow-upExclusion Criteria:Current hydroxyurea treatment (or within the past 6 months)Regular blood transfusions (6 or more within the past 12 months)Transfusion within the last 30 days (temporary exclusion)Known malignancy or other known chronic illnesses including but not limited to active tuberculosis, renal diseaseCurrent participation in other therapeutic clinical trials, or within 6 months of prior disease-modifying treatments

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05662098). StuddyBuddy aggregates publicly available trial information.