Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Combination Iron Chelation Therapy

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00004982
First received: March 13, 2000
Last updated: January 12, 2010
Last verified: January 2010

March 13, 2000
January 12, 2010
December 1998
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00004982 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Combination Iron Chelation Therapy
Not Provided

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
  • Iron Overload
  • Thalassemia
Drug: Combination Iron Chelation Therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
November 2002
Not Provided

Inclusion Criteria:

  • Iron overload

Exclusion Criteria:

  • Overt cardiac disease
Both
7 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00004982
CHELATION (completed), 1R01DK55463-01
Not Provided
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP