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Chelation Therapy of Iron Overload With Pyridoxal Isonicotinoyl Hydrazone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00000588
Recruitment Status : Completed
First Posted : October 28, 1999
Last Update Posted : February 11, 2014
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Case Western Reserve University

Brief Summary:
To demonstrate the safety and effectiveness of orally-administered pyridoxal isonicotinoyl hydrazone (PIH) for the chronic treatment of iron overload.

Condition or disease Intervention/treatment Phase
Anemia (Iron-Loading) Beta-Thalassemia Hematologic Diseases Hemoglobinopathies Thalassemia Iron Overload Drug: chelation therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : June 1989

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Study 1: Approximately 12 to 18 adult men and non-pregnant women with iron-loading anemias in the United States and 12 to 18 similar patients in Thailand each year.

Study 2: Approximately 6 to 12 well-chelated patients with transfusion-dependence.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000588


Sponsors and Collaborators
Case Western Reserve University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Gary Brittenham Case Western Reserve University

Publications:
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ClinicalTrials.gov Identifier: NCT00000588    
Other Study ID Numbers: 308
R01HL042814 ( U.S. NIH Grant/Contract )
First Posted: October 28, 1999    Key Record Dates
Last Update Posted: February 11, 2014
Last Verified: February 2002
Additional relevant MeSH terms:
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Thalassemia
Hematologic Diseases
beta-Thalassemia
Hemoglobinopathies
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases