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Combination Iron Chelation Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004982
Recruitment Status : Completed
First Posted : March 14, 2000
Last Update Posted : January 14, 2010
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Description
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Brief Summary:
Patients with beta-thalassemia (Cooley's Anemia) continue to suffer from the transfusion-induced iron overload due to the inadequacies of current iron-chelation therapy. Compliance with the use of the only FDA-approved drug for removing excess iron from patients (Desferal) continues to be a major problem despite convincing evidence that it markedly reduces morbidity and prolongs life. The full potential of iron-chelation therapy will not be realized until an orally-effective drug is available. This small trial is testing the premise that a combination of drugs as a new approach to iron chelation therapy may reduce side effects and increase efficacy. If both drugs can be given orally, there may be a better chance of finding a suitable alternative to Desferal. Several combinations of experimental iron chelating drugs are being used in this trial.

Condition or disease Intervention/treatment Phase
Iron Overload Thalassemia Drug: Combination Iron Chelation Therapy Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 1998
Study Completion Date : November 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Thalassemia

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Iron overload

Exclusion Criteria:

  • Overt cardiac disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004982


Locations
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United States, New York
Cornell University Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information
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ClinicalTrials.gov Identifier: NCT00004982    
Obsolete Identifiers: NCT00004536
Other Study ID Numbers: CHELATION (completed)
1R01DK055463-01 ( U.S. NIH Grant/Contract )
First Posted: March 14, 2000    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: January 2010
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
chelation therapy
combination chemotherapy
iron poisoning
thalassemia
 chelating agent
deferoxamine
drug screening /evaluation
therapy evaluation
Additional relevant MeSH terms:
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Thalassemia
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases