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Effectiveness of Nontraditional Hydroxyurea Algorithms: Novel and Clinical Evaluations (ENHANCE)

NCT07177300 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-09-16

No results posted yet for this 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.

Conditions

  • Sickle Cell Anemia (HbSS)
  • Sickle-β0-thalassemia (HbSβ0)

Interventions

DRUG

PK-optimized oral hydroxyurea at MTD until 15 years of age.

Because people are different, we will measure how each participant's body absorbs and eliminates the medicine, hydroxyurea, using blood tests. This information will be used to determine the best dose for each participant (rather than using the same weight-based dose for everyone).

Sponsors & Collaborators

  • Greater Cincinnati Foundation

    collaborator UNKNOWN

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Charles T. Quinn, Professor of Pediatrics, M.D., M.S. · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-19
Primary Completion
2026-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07177300 on ClinicalTrials.gov