Combination Iron Chelation Therapy

Thalassemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004982
• Other study ID #: CHELATION (completed)
• Secondary ID: 1R01DK055463-01
• Status: Completed
• Phase: Phase 1
• First received: March 13, 2000
• Last updated: January 12, 2010
• Start date: December 1998
• Est. completion date: November 2002

Study information

• Verified date: January 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00004536

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

• Iron overload

Exclusion Criteria:

• Overt cardiac disease

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Iron Overload
• Thalassemia

Intervention

Drug:
• Combination Iron Chelation Therapy

Locations

Country	Name	City	State
United States	Cornell University Medical College	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States,