Alternative Dosing And Prevention of Transfusions (ADAPT)

• Status: Recruiting
• Trial end date: 2025-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborator: Jinja Regional Referral Hospital (JRRH), Sickle Cell Clinic, Jinja, Uganda
• Treatments: Hydroxyurea

Criteria

Inclusion Criteria:

• Patients with documented HbSS disease

• Age: ≥ 12 months and ≤ 10 years of age, at the time of enrollment

• Parent or guardian willing and able to provide informed consent

• Able to comply with all study related treatments, evaluations, and follow-up

Exclusion 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 disease

• Current participation in other therapeutic clinical trials, or within 6 months of prior disease-modifying treatments