Chelation Therapy of Iron Overload With Pyridoxal Isonicotinoyl Hydrazone - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00000588

Purpose

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

Condition	Intervention	Phase
Anemia (Iron-Loading) Beta-Thalassemia Hematologic Diseases Hemoglobinopathies Thalassemia Iron Overload	Drug: chelation therapy	Phase II

Genetics Home Reference related topics: beta thalassemia

MedlinePlus related topics: Anemia Thalassemia

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date:

June 1989

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000588

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigator:

Gary Brittenham

Case Western Reserve University

More Information

Publications:

Brittenham GM. Pyridoxal isonicotinoyl hydrazone. Effective iron chelation after oral administration. Ann N Y Acad Sci. 1990;612:315-26. Review. No abstract available.

Brittenham GM. Pyridoxal isonicotinoyl hydrazone: an effective iron-chelator after oral administration. Semin Hematol. 1990 Apr;27(2):112-6. Review. No abstract available.

Olivieri NF, Brittenham GM, Matsui D, Berkovitch M, Blendis LM, Cameron RG, McClelland RA, Liu PP, Templeton DM, Koren G. Iron-chelation therapy with oral deferipronein patients with thalassemia major. N Engl J Med. 1995 Apr 6;332(14):918-22.

Nathan DG. An orally active iron chelator. N Engl J Med. 1995 Apr 6;332(14):953-4. No abstract available.

Study ID Numbers:	308
Study First Received:	October 27, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00000588
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Metabolic Diseases
Hematologic Diseases
Beta-thalassemia
Anemia
Pyridoxal isonicotinoyl hydrazone
Anemia, Hemolytic
Iron Metabolism Disorders
Thalassemia
Anemia, Hemolytic, Congenital

Thalassemia minor
Genetic Diseases, Inborn
Beta-Thalassemia
Hemoglobinopathies
Iron Overload
Metabolic disorder
Hemoglobinopathy
Iron

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents
Chelating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009