Combination Iron Chelation Therapy

• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00004982
• Collaborator: (none)
• Location: 1
• Duration (Months): 47

Study Details

Study Description

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

• Study Type: Interventional
• Allocation: Randomized
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Dec 1, 1998
• Study Completion Date: Nov 1, 2002

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 7 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Iron overload

Exclusion Criteria:

• Overt cardiac disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cornell University Medical College	New York	New York	United States	10021

Sponsors and Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00004982
• Other Study ID Numbers: CHELATION (completed); 1R01DK055463-01; NCT00004536
• First Posted: Mar 14, 2000
• Last Update Posted: Jan 14, 2010
• Last Verified: Jan 1, 2010

• Keywords provided by , ,: chelation therapy; combination chemotherapy; iron poisoning; thalassemia; chelating agent; deferoxamine; drug screening /evaluation; therapy evaluation
• Additional relevant MeSH terms: Thalassemia; Iron Overload

Study Results

No Results Posted as of Jan 14, 2010