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NCT00981370 · ClinicalTrials.gov registry record · Phase 3
Clinical Importance of Treating Iron Overload in Sickle Cell Disease
A Phase 3 study, sponsored by Children's Hospital Los Angeles.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1
- Enrollment target
NCT00981370 is a Phase 3 study that was terminated before completion, run by Children's Hospital Los Angeles. The registered enrollment target is 1 participants.
The verdict
NCT00981370, a Phase 3 study, was terminated before completion, sponsored by Children's Hospital Los Angeles.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1 participants
- Enrollment target
Study Summary
Hypothesis: The investigators suspect that significant degrees of iron overload in subjects with SCD result in decreased red cell survival, abnormal endothelial function and markedly dysregulated autonomic function. Furthermore, the investigators anticipate that the magnitude of these effects is proportional not only to the magnitude of total body iron stores but also to the duration of exposure to the high iron levels in tissues. Primary objective To determine if red cell survival as assessed by 51Cr red cell survival analysis, hemoglobin level, reticulocyte count, lactic acid dehydrogenase, and plasma hemoglobin in sickle cell patients is related to the degree of iron overload. Secondary objective(s) 1. Determine if the magnitude of endothelial-dependant vasodilation is related to The degree of iron overload. 2. Determine if the degree of change in cardiac beat to beat variability in response to hypoxic exposure or to cold exposure ("cold-face-test") is related the magnitude of iron overload. The primary measure of iron overload will be MRI determination of liver iron concentration.
Interventions
- DRUG deferasirox
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2009-04 |
| Est. Completion | 2010-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00981370
The ClinicalTrials.gov registry entry for NCT00981370 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Los Angeles, which has 119 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which deferasirox is the first listed.
NCT00981370 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00981370 about?
NCT00981370 is a clinical study titled "Clinical Importance of Treating Iron Overload in Sickle Cell Disease". Hypothesis: The investigators suspect that significant degrees of iron overload in subjects with SCD result in decreased red cell survival, abnormal endothelial function and markedly dysregulated autonomic function. Furthermore, the investigators anticipate that the magnitude of these effects is pr...
What is the current status of trial NCT00981370?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1 participants. The study started on 2009-04. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00981370?
The interventions under investigation include: deferasirox (DRUG).
Who is sponsoring clinical trial NCT00981370?
This trial is sponsored by Children's Hospital Los Angeles, which has 119 total clinical trials registered on ClinicalTrials.gov.
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