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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 is a Phase 3 study that has completed, run by Lifespan. The registered enrollment target is 104 participants.
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.
Interventions
- DRUG Hydroxyurea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2019-01-17 |
| Est. Completion | 2025-03-19 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03789591
The ClinicalTrials.gov registry entry for NCT03789591 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 104 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Lifespan, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hydroxyurea is the first listed.
NCT03789591 reports 0 study locations.
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.
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