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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: Clinical Trial Phase 3 study, sponsored by Children's Hospital Los Angeles.

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, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 1 participants
Start Date 2009-04
Est. Completion 2010-12
Phase Phase 3
Children's Hospital Los Angeles

119 total trials

Why NCT00981370 stopped before completion

NCT00981370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).

The record links to 0 conditions, and to 1 intervention - of which deferasirox is the first listed.

NCT00981370 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00981370's enrollment target sits among peer trials

1 2001st of 2000 the lowest of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00981370, the US trial registry maintained by the National Library of Medicine. NCT00981370 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.