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Combination Iron Chelation Therapy

Primary Purpose

Iron Overload, Thalassemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Combination Iron Chelation Therapy
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Overload focused on measuring chelation therapy, combination chemotherapy, iron poisoning, thalassemia, chelating agent, deferoxamine, drug screening /evaluation, therapy evaluation

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Iron overload Exclusion Criteria: Overt cardiac disease

Sites / Locations

  • Cornell University Medical College

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 13, 2000
Last Updated
January 12, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00004982
Brief Title
Combination Iron Chelation Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
December 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Overload, Thalassemia
Keywords
chelation therapy, combination chemotherapy, iron poisoning, thalassemia, chelating agent, deferoxamine, drug screening /evaluation, therapy evaluation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Combination Iron Chelation Therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Iron overload Exclusion Criteria: Overt cardiac disease
Facility Information:
Facility Name
Cornell University Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Combination Iron Chelation Therapy

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