Trial · NCT07177300
Effectiveness of Nontraditional Hydroxyurea Algorithms: Novel and Clinical Evaluations (ENHANCE)
NCT07177300, Phase 4, Recruiting, Children's Hospital Medical Center, Cincinnati
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effectiveness of Nontraditional Hydroxyurea Algorithms: Novel and Clinical Evaluations (ENHANCE). Trials, record NCT07177300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07177300
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effectiveness of Nontraditional Hydroxyurea Algorithms: Novel and Clinical Evaluations (ENHANCE)
- NCT number
- NCT07177300
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Conditions
- Sickle Cell Anemia (HbSS), Sickle-β0-thalassemia (HbSβ0)
- Interventions
- PK-optimized oral hydroxyurea at MTD until 15 years of age.
- First posted
- 2025-09-16
- Last updated
- 2025-09-16
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Composite Organ Injury | Through study completion, an average of 10 years | 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% |
| Secondary | longitudinal change in fetal hemoglobin percentage (HbF%) | Through study completion, an average of 10 years | HbF is a well-established mechanistic surrogate marker in SCA that is strongly associated with reduced sickling and organ injury across multiple organ systems. This endpoint will quantify the sustained biological effectiveness of early PK-guided hydroxyurea dosing. |
| Secondary | Longitudinal change in hemoglobin concentration (g/dL) | Through study completion, an average of 10 years. | A beneficial laboratory response to hydroxyurea would include less severe anemia (measured by hemoglobin concentration). This is reported in a complete blood count (CBC). |
| Secondary | Longitudinal change in reticulocyte count (10^9/L) | Through study completion, an average of 10 years. | A beneficial laboratory response to hydroxyurea would include a decreased reticulocyte count, indicating less severe anemia. This is reported with a complete blood count (CBC). |
| Secondary | Longitudinal change in absolute neutrophil count (10^9/L) | Through study completion, an average of 10 years. | A surrogate marker of hydroxyurea effectiveness and adherence is the absolute neutrophil count (ANC). Hydroxyurea is titrated according to the ANC. This is reported in a complete blood count (CBC) with differential leukocyte count. |
| Secondary | Longitudinal change in mean cell volume (fL) | Through study completion, an average of 10 years. | A surrogate marker of hydroxyurea effectiveness and adherence is the mean cell volume (MCV). This is reported in a complete blood count (CBC). |
| Secondary | F-cell fraction (%) | Through study completion, an average of 10 years. | Flow cytometric determination of the fraction of HbF-containing red blood cells (F-cells). |
| Secondary | Adverse events | Through study completion, an average of 10 years. | The occurrence of adverse events while on study will be continually monitored and recorded. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers13
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07177300
GET https://conductscience.org/api/trials/v1/NCT07177300/registered