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NCT02042222 · ClinicalTrials.gov registry record · Early Phase 1
Novel Dose Escalation to Predict Treatment With Hydroxyurea
A Early Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 70
- Enrollment target
NCT02042222 is a Early Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 70 participants.
The verdict
NCT02042222, a Early Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
Sickle cell disease is a disorder in which red blood cells (RBCs) are abnormally shaped. This can result in painful episodes, serious infections, chronic anemia (a decrease in the number of red blood cells), and damage to body organs. Hydroxyurea therapy offers significant benefits for infants, children, and adolescents with sickle cell anemia. These include a reduction in the frequency of pain crises and acute chest syndrome (inflammation of the lungs) and an increase in hemoglobin (the oxygen-carrying protein) in the blood. Patients on hydroxyurea who receive a maximum tolerated dose (MTD) that is specific for them have greater clinical benefit than those who receive a standard lower dose. There is, however, no way currently to predict the MTD for individual patients. As such, MTD for each patient is currently determined by gradual increases in the dose over several months. This process is time-consuming, requires monthly clinic visits, and delays the benefits of hydroxyurea therapy. Our research group has come up with an equation that could be used to predict each patient's MTD using baseline clinical and laboratory measures before starting hydroxyurea treatment. The purpose of this research study is to compare the use of our equation for predicting MTD to the current standard practice of gradually increasing the hydroxyurea dose until MTD is reached. We want to see if the use of our predictive equation will allow us to achieve MTD faster and with no more side effects than with the standard practice.
Interventions
- DRUG Hydroxyurea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2013-10 |
| Est. Completion | 2020-07-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02042222
The ClinicalTrials.gov registry entry for NCT02042222 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hydroxyurea is the first listed.
NCT02042222 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02042222 about?
NCT02042222 is a clinical study titled "Novel Dose Escalation to Predict Treatment With Hydroxyurea". Sickle cell disease is a disorder in which red blood cells (RBCs) are abnormally shaped. This can result in painful episodes, serious infections, chronic anemia (a decrease in the number of red blood cells), and damage to body organs. Hydroxyurea therapy offers significant benefits for infants, chil...
What is the current status of trial NCT02042222?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 70 participants. The study started on 2013-10. Estimated completion is 2020-07-31.
What interventions are being tested in trial NCT02042222?
The interventions under investigation include: Hydroxyurea (DRUG).
Who is sponsoring clinical trial NCT02042222?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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