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Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia

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: NCT00069862
Recruitment Status : Completed
First Posted : October 3, 2003
Last Update Posted : March 5, 2015
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief Summary:
A clinical trial designed to compare the safety and iron excretion properties of desferoxamine (DFO) and deferitrin (GT56-252), an experimental oral iron chelator.

Condition or disease Intervention/treatment Phase
Beta-Thalassemia Drug: Deferitrin (GT56-252) Drug: desferoxamine (DFO) Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia
Study Start Date : September 2003
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron Thalassemia

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. safety and tolerability
  2. iron excretion in urine and stool
  3. pharmacokinetic measurements

Eligibility Criteria
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Information from the National Library of Medicine

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

Inclusion Criteria:

  • Beta-thalassemia patients, 18 years of age or older, currently undergoing chronic blood transfusion therapy and iron chelation therapy who weigh more than 40 kg.
  • No clinically significant findings on physical exam, medical history, or screening laboratories.
  • Serum ferritin greater than 500 ng/mL, serum creatine creatinine within the normal range and platelet count greater than 100,000/mm3.
  • Willing and able to discontinue DFO or L1 for the period of study.
  • Woman of child-bearing potential must have a negative serum pregnancy test at screening and use a medically acceptable form of birth control during the study and for 1 month afterward. Male patients must also use barrier contraceptives during the study and for 1 month afterward.
  • Have a level of understanding and willingness to cooperate with the confinement and all procedures. Able to provide voluntary signed/dated written informed consent.

Exclusion Criteria:

  • Serious medical condition unrelated to Beta-Thalassemia.
  • Participation in a previous investigational drug study within 30 days preceding screening.
  • Patients with a known allergy to DFO that prevents chronic administration.
Contacts and Locations
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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): NCT00069862


Locations
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United States, New York
The New York Presbyterian Hospital-Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Genzyme, a Sanofi Company
More Information
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ClinicalTrials.gov Identifier: NCT00069862    
Other Study ID Numbers: GTC-134-102
First Posted: October 3, 2003    Key Record Dates
Last Update Posted: March 5, 2015
Last Verified: March 2015
Keywords provided by Sanofi:
Beta Thalassemia
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Iron Overload
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Iron Metabolism Disorders
Metabolic Diseases