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NCT03825341
Hydroxyurea Therapy: Optimizing Access in Pediatric Populations Everywhere
Phase 2 trial testing Hydroxyurea in Sickle Cell Disease in 1 participant. Terminated before completion.
20 January 2022
Quick facts
| Lead sponsor | St. Jude Children's Research Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 10 June 2019 |
| Primary completion | 20 January 2022 |
| Estimated completion | 20 January 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Hydroxyurea — full drug profile →
- Hydroxyurea Oral Capsule — full drug profile →
Conditions studied
- Sickle Cell Disease — all drugs for Sickle Cell Disease →
- Thalassemia — all drugs for Thalassemia →
Sponsor
St. Jude Children's Research Hospital
Who can join
Adults 9 Months to 18, any sex, with Sickle Cell Disease or Thalassemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Primary Objective 1. Define the pharmacokinetics of liquid-formulated HU in infants (9 months to \<2 years) 2. Assess the relative bioavailability of HU "sprinkles" compared to capsules in children and adolescents (≥2 to 18 years). Secondary Objective: Compare PK parameters in infants versus older children on this study and those from our previous "Pharmacokinetics and Bioavailability of a Liquid Formulation of Hydroxyurea in Pediatric Patients with Sickle Cell Anemia" (NCT01506544) trial. Exploratory Objectives: Capture information regarding the taste of HU sprinkles using palatability questionnaire. This trial is an open label, single center assessment of the pharmacokinetics of two formulations of hydroxyurea (HU) designed to (1) determine the pharmacokinetic profile of a liquid formulation in infants and to (2) determine the bioavailability of "sprinkles", a novel method of administration for older children. The study aims to generate data to facilitate FDA approval for HU in children and potentially validate a new mode of administration ("sprinkles") that will optimize access and adherence for children in the US and globally.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Hydroxyurea (hydroxycarbamide) for sickle cell disease.
Rankine-Mullings AE, Nevitt SJ. · · 2022 · cited 42× · PMID 36047926 · DOI 10.1002/14651858.cd002202.pub3
Verify or expand the search:
- PubMed search for NCT03825341
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other recruiting trials for Sickle Cell Disease
Currently open trials in the same condition.
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- NCT06260891 — Zinc Supplementation in Sickle Cell Disease: A Precursor to the Think Zinc for Bones Trial · Phase 2 · recruiting
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Other St. Jude Children's Research Hospital trials
Trials by the same sponsor.
- NCT07222735 — Hypofractionated Radiation in Combination With B7-H3-CAR T Cells for Pediatric Patients With Relapsed/Refractory Sarcoma · Phase 1 · recruiting
- NCT07085338 — A Phase II Study With a Safety Run-In of the Addition of N-803 to a Chemoimmunotherapy Backbone for the Treatment of Pat · Phase 2 · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03825341 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by St. Jude Children's Research Hospital
- Last refreshed: 18 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03825341.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing