Combination Iron Chelation Therapy - Tabular View

Tracking Information
First Received Date ^ICMJE	March 13, 2000
Last Updated Date	June 23, 2005
Start Date ^ICMJE	December 1998
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00004982 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Combination Iron Chelation Therapy
Official Title ^ICMJE
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.
Detailed Description
Study Phase	Phase I
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Open Label
Condition ^ICMJE	Iron Overload Thalassemia
Intervention ^ICMJE	Drug: Combination Iron Chelation Therapy
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE
Completion Date	November 2002
Primary Completion Date
Eligibility Criteria ^ICMJE	Inclusion Criteria: Iron overload Exclusion Criteria: Overt cardiac disease
Gender	Both
Ages	7 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00004982
Responsible Party
Study ID Numbers ^ICMJE	CHELATION, 1R01DK55463-01
Study Sponsor ^ICMJE	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date	July 2003
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP