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NCT03825341 · ClinicalTrials.gov registry record · Phase 2
Hydroxyurea Therapy: Optimizing Access in Pediatric Populations Everywhere
A Phase 2 study, sponsored by St. Jude Children's Research Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT03825341: Clinical Trial Phase 2 study, sponsored by St. Jude Children's Research Hospital.
NCT03825341 is a Phase 2 study that was terminated before completion, run by St. Jude Children's Research Hospital. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03825341, a Phase 2 study, was terminated before completion, sponsored by St. Jude Children's Research Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Summary statistics including mean, standard deviation (SD) will be reported.
Interventions
- DRUG Hydroxyurea
- DRUG Hydroxyurea Oral Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-06-10 |
| Est. Completion | 2022-01-20 |
| Phase | Phase 2 |
Why NCT03825341 stopped before completion
NCT03825341 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Hydroxyurea is the first listed.
NCT03825341 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03825341 about?
NCT03825341 is a clinical study titled "Hydroxyurea Therapy: Optimizing Access in Pediatric Populations Everywhere". 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 olde...
What is the current status of trial NCT03825341?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2019-06-10. Estimated completion is 2022-01-20.
What interventions are being tested in trial NCT03825341?
The interventions under investigation include: Hydroxyurea (DRUG), Hydroxyurea Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT03825341?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03825341's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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