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NCT01531387 · ClinicalTrials.gov registry record · Phase 3
Sparing Conversion to Abnormal TCD (Transcranial Doppler) Elevation (SCATE)
A Phase 3 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Terminated
- Registry status
- Phase 3
- Development phase
- 38
- Enrollment target
NCT01531387 is a Phase 3 study that was terminated before completion, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 38 participants.
The verdict
NCT01531387, a Phase 3 study, was terminated before completion, sponsored by Children's Hospital Medical Center, Cincinnati.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 38 participants
- Enrollment target
Study Summary
The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy (hydroxyurea) to standard care (observation) in children with sickle cell anemia and conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative regimen (hydroxyurea) to be declared superior to the standard treatment regimen (observation), the hydroxyurea-treated group must have a three-fold reduction in the incidence of conversion to abnormal TCD velocities (≥ 200 cm/sec), compared to the standard treatment arm.
Interventions
- DRUG Hydroxyurea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2012-05 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01531387
The ClinicalTrials.gov registry entry for NCT01531387 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Hydroxyurea is the first listed.
NCT01531387 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01531387 about?
NCT01531387 is a clinical study titled "Sparing Conversion to Abnormal TCD (Transcranial Doppler) Elevation (SCATE)". The primary goal of the Phase III SCATE trial is to compare 30 months of alternative therapy (hydroxyurea) to standard care (observation) in children with sickle cell anemia and conditional (170 - 199cm/sec) Transcranial Doppler (TCD) velocities. For the alternative regimen (hydroxyurea) to be decla...
What is the current status of trial NCT01531387?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 38 participants. The study started on 2012-05. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01531387?
The interventions under investigation include: Hydroxyurea (DRUG).
Who is sponsoring clinical trial NCT01531387?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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