We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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
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

  Show Detailed Description

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
U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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)
Principal Investigator: Gary Brittenham Case Western Reserve University

ClinicalTrials.gov Identifier: NCT00000588     History of Changes
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:
Iron Overload
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Pyridoxal isonicotinoyl hydrazone
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents