We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Chelation Therapy of Iron Overload With Pyridoxal Isonicotinoyl Hydrazone

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00000588
First Posted: October 28, 1999
Last Update Posted: February 11, 2014
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.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Case Western Reserve University
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Study Start Date: June 1989
  Show Detailed Description

  Eligibility

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
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
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
Principal Investigator: Gary Brittenham Case Western Reserve University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000588     History of Changes
Other Study ID Numbers: 308
R01HL042814 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 1999
First Posted: October 28, 1999
Last Update Posted: February 11, 2014
Last Verified: February 2002

Additional relevant MeSH terms:
Thalassemia
Iron Overload
Hematologic Diseases
beta-Thalassemia
Hemoglobinopathies
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases
Pyridoxal isonicotinoyl hydrazone
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Iron Chelating Agents