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NCT07177300 · ClinicalTrials.gov registry record · Phase 4
Effectiveness of Nontraditional Hydroxyurea Algorithms: Novel and Clinical Evaluations (ENHANCE)
A Phase 4 study of Sickle Cell Anemia (HbSS) and Sickle-β0-thalassemia (HbSβ0), sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT07177300: Recruiting Phase 4 study of Sickle Cell Anemia (HbSS) and Sickle-β0-thalassemia (HbSβ0), sponsored by Children's Hospital Medical Center, Cincinnati.
NCT07177300 is a Phase 4 study of Sickle Cell Anemia (HbSS) and Sickle-β0-thalassemia (HbSβ0) that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 50 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07177300, a Phase 4 study of Sickle Cell Anemia (HbSS) and Sickle-β0-thalassemia (HbSβ0), is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
The main reason for this research study is to learn more about hydroxyurea and the treatment of sickle cell anemia (SCA). Hydroxyurea is a medication that has been studied for many years and has been shown to provide benefits for people with SCA. In this research study, the investigators hope to learn more about how to improve the dosing and monitoring of hydroxyurea and learn more about the long-term effects of hydroxyurea over time. Hydroxyurea is usually dosed based only on your weight. Our study will use a new way to select a starting dose that is based on how each patient absorbs hydroxyurea.
Primary Outcome
Evidence of injury in any of four critical organ systems: brain, kidney, heart, or spleen. Participants will be classified as having met the composite endpoint if they fulfill at least one of the organ-specific criteria listed: cerebral infarction (silent or overt) or steno-occlusive vasculopathy by MRI of brain; urine albumin-to-creatinine ratio (UACR) \> 300 mg/g; extracellular volume fraction (ECV) \> 0.35 on cardiac MRI; or erythrocyte pit count \< 5%
Conditions Studied
Interventions
- DRUG PK-optimized oral hydroxyurea at MTD until 15 years of age.
Study Locations (1)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2024-12-19 |
| Est. Completion | 2028-12 |
| Phase | Phase 4 |
What NCT07177300 shows while recruiting
NCT07177300 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 2 conditions, with Sickle Cell Anemia (HbSS) appearing as the primary indexed condition, and to 1 intervention - of which PK-optimized oral hydroxyurea at MTD until 15 years of age. is the first listed.
NCT07177300 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT07177300 about?
NCT07177300 is a clinical study titled "Effectiveness of Nontraditional Hydroxyurea Algorithms: Novel and Clinical Evaluations (ENHANCE)". The main reason for this research study is to learn more about hydroxyurea and the treatment of sickle cell anemia (SCA). Hydroxyurea is a medication that has been studied for many years and has been shown to provide benefits for people with SCA. In this research study, the investigators hope to le...
What is the current status of trial NCT07177300?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2024-12-19. Estimated completion is 2028-12.
What conditions does trial NCT07177300 study?
This clinical trial studies the following conditions: Sickle Cell Anemia (HbSS), Sickle-β0-thalassemia (HbSβ0).
What interventions are being tested in trial NCT07177300?
The interventions under investigation include: PK-optimized oral hydroxyurea at MTD until 15 years of age. (DRUG).
Who is sponsoring clinical trial NCT07177300?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07177300 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07177300's enrollment target sits among peer trials
50 1255th of 2000 higher than 679 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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