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NCT03789591 · ClinicalTrials.gov registry record · Phase 3
Hydroxyurea Optimization Through Precision Study
A Phase 3 study, sponsored by Lifespan.
- Completed
- Registry status
- Phase 3
- Development phase
- 104
- Enrollment target
NCT03789591: Completed Phase 3 study, sponsored by Lifespan.
NCT03789591 is a Phase 3 study that has completed, run by Lifespan. The registered enrollment target is 104 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03789591, a Phase 3 study, has completed, sponsored by Lifespan.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 104 participants
- Enrollment target
Study Summary
Hydroxyurea Optimization through Precision Study (HOPS) is a prospective, multi-center, randomized trial that will directly compare a novel, individualized dosing strategy of hydroxyurea to standard weight-based dosing for children with SCA. The primary objective of the study is to evaluate whether a pharmacokinetics-based starting hydroxyurea dose thieves superior fetal hemoglobin response to to standard weight-based initial dosing. Patients will be recruited from the pediatric sickle cell clinic at Cincinnati Children's Hospital Medical Center and from additional pediatric sickle cell centers within the United States.
Primary Outcome
The primary outcome will be HbF response six months after starting hydroxyurea therapy with the hypothesis that participants in the Alternative Arm (PK-guided starting dose) will have at least 5% higher HbF than the Standard Arm (20 mg/kg starting dose)
Interventions
- DRUG Hydroxyurea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2019-01-17 |
| Est. Completion | 2025-03-19 |
| Phase | Phase 3 |
What the finished NCT03789591 record still lists
NCT03789591 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which Hydroxyurea is the first listed.
NCT03789591 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03789591 about?
NCT03789591 is a clinical study titled "Hydroxyurea Optimization Through Precision Study". Hydroxyurea Optimization through Precision Study (HOPS) is a prospective, multi-center, randomized trial that will directly compare a novel, individualized dosing strategy of hydroxyurea to standard weight-based dosing for children with SCA. The primary objective of the study is to evaluate whether ...
What is the current status of trial NCT03789591?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 104 participants. The study started on 2019-01-17. Estimated completion is 2025-03-19.
What interventions are being tested in trial NCT03789591?
The interventions under investigation include: Hydroxyurea (DRUG).
Who is sponsoring clinical trial NCT03789591?
This trial is sponsored by Lifespan, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03789591's enrollment target sits among peer trials
104 1671st of 2000 higher than 327 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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