Active — Not RecruitingEarly Phase 1

Alternative Dosing And Prevention of Transfusions (ADAPT)

Uganda100 participantsStarted 2022-06-16

Plain-language 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.

Who can participate

Age range12 Months – 10 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

To compare the rates of blood transfusions overall and by specific indications in children with sickle cell anaemia (SCA), prior to and during hydroxyurea treatment

Timeframe: One year (Enrollment - Month 15)

Trial details

NCT IDNCT05662098

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Sickle Cell Disease trials