Alternative Dosing And Prevention of Transfusions (ADAPT) (NCT05662098) | Clinical Trial Compass
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 range
12 Months – 10 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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