NCT00000595

Brief Summary

To determine whether deferoxamine prevented the complications of transfusional iron overload.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 1978

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1978

Completed
16.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1994

Completed
5.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
Last Updated

November 26, 2013

Status Verified

May 1, 2000

First QC Date

October 27, 1999

Last Update Submit

November 25, 2013

Conditions

Anemia (Iron-Loading)Beta-ThalassemiaHematologic DiseasesHemoglobinopathiesThalassemiaIron OverloadHemochromatosis

Interventions

deferoxamineDRUG

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Males and females, 5 years or older, with transfusional hemochromatosis.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • Nienhuis AW, Griffith P, Strawczynski H, Henry W, Borer J, Leon M, Anderson WF. Evaluation of cardiac function in patients with thalassemia major. Ann N Y Acad Sci. 1980;344:384-96. doi: 10.1111/j.1749-6632.1980.tb33677.x.

    PMID: 6930878BACKGROUND

  • Brittenham GM, Griffith PM, Nienhuis AW, McLaren CE, Young NS, Tucker EE, Allen CJ, Farrell DE, Harris JW. Efficacy of deferoxamine in preventing complications of iron overload in patients with thalassemia major. N Engl J Med. 1994 Sep 1;331(9):567-73. doi: 10.1056/NEJM199409013310902.

    PMID: 8047080BACKGROUND

MeSH Terms

Conditions

Anemiabeta-ThalassemiaHematologic DiseasesHemoglobinopathiesThalassemiaIron OverloadHemochromatosis

Interventions

Deferoxamine

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesAnemia, Hemolytic, CongenitalAnemia, HemolyticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesMetal Metabolism, Inborn ErrorsMetabolism, Inborn Errors

Intervention Hierarchy (Ancestors)

Hydroxamic AcidsHydroxylaminesAminesOrganic ChemicalsHydroxy AcidsCarboxylic Acids

Study Officials

  • Neal Young

    Laboratory of Hematology, NHLBI

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

January 1, 1978

Study Completion

September 1, 1994

Last Updated

November 26, 2013

Record last verified: 2000-05