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Clinical Importance of Treating Iron Overload in Sickle Cell Disease

NCT00981370 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-02-08

Study results available
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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.

Conditions

  • Anemia, Sickle Cell
  • Transfusion Hemosiderosis

Interventions

DRUG

deferasirox

Treatment starting dose of 20mg/kg/day based on subjects baseline LIC (liver iron concentration) and gradually escalate the dose to a maximum of 35 mg/kg/day based upon toxicity. Duration is up to a max of 12 months.

Sponsors & Collaborators

Principal Investigators

  • Thomas D. Coates, M.D. · Children's Hospital Los Angeles

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2010-10-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00981370 on ClinicalTrials.gov