- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00004982
Combination Iron Chelation Therapy
January 12, 2010 updated by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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New York, New York, United States, 10021
- Cornell University Medical College
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Iron overload
Exclusion Criteria:
- Overt cardiac disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: None (Open Label)
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 1998
Study Completion
November 1, 2002
Study Registration Dates
First Submitted
March 13, 2000
First Submitted That Met QC Criteria
March 13, 2000
First Posted (Estimate)
March 14, 2000
Study Record Updates
Last Update Posted (Estimate)
January 14, 2010
Last Update Submitted That Met QC Criteria
January 12, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHELATION (completed)
- 1R01DK055463-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Iron Overload
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Novartis PharmaceuticalsCompletedTransfusional Iron OverloadItaly
-
ApoPharmaCompletedTransfusional Iron OverloadEgypt, Cyprus, Oman, Saudi Arabia, Turkey
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Novartis PharmaceuticalsCompletedChronic Iron OverloadGermany
-
Novartis PharmaceuticalsCompletedCardiac Iron OverloadTaiwan, Egypt, Thailand, Turkey, United Kingdom, Italy, Canada, Greece
-
Novartis PharmaceuticalsNot yet recruiting
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Assiut UniversityUnknownPlatelet Changes in Cases of Iron Overload
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ApoPharmaCompletedIron Overload Due to Repeated Red Blood Cell TransfusionsUnited States, Canada, Greece, Italy
-
Assiut UniversityUnknownPlatelet Changes in Cases of Iron Overload
-
ShireTerminatedIron Overload Due to Repeated Red Blood Cell TransfusionsCanada, United States, Thailand, Italy, United Kingdom
-
ShireTerminatedPharmacokinetics of SSP-004184 in the Treatment of Chronic Iron Overload Requiring Chelation TherapyIron Overload Due to Repeated Red Blood Cell TransfusionsUnited States, Canada, Lebanon, Italy, Egypt
Clinical Trials on Combination Iron Chelation Therapy
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Novartis PharmaceuticalsTerminatedAplastic AnemiaRussian Federation
-
Novartis PharmaceuticalsCompletedIron Overload | Myelodysplastic SyndromeUnited States, Canada
-
Optimum Health, Natural Healthcare CenterUnknownChronic Lymphocytic Leukemia
-
Chang Gung Memorial HospitalUnknownInflammation | Anemia | Malnutrition | Lead PoisoningTaiwan
-
Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)Terminated
-
Case Western Reserve UniversityNational Heart, Lung, and Blood Institute (NHLBI)CompletedHematologic Diseases | Iron Overload | Hemoglobinopathies | Thalassemia | Beta-Thalassemia | Anemia (Iron-Loading)
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St. Jude Children's Research HospitalNational Heart, Lung, and Blood Institute (NHLBI)TerminatedHematologic Diseases | Anemia, Sickle Cell | Cerebrovascular Accident | HemochromatosisUnited States
-
Mt. Sinai Medical Center, MiamiCompletedPeripheral Arterial Disease | Critical Limb IschemiaUnited States
-
Ain Shams UniversityCompleted
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Elliott VichinskyCompletedIron Overload | ThalassemiaUnited States