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

This study has been completed.
Sponsor:
Information provided by:
Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:
NCT00069862
First received: October 2, 2003
Last updated: June 19, 2008
Last verified: May 2007

October 2, 2003
June 19, 2008
September 2003
Not Provided
  • safety and tolerability
  • iron excretion in urine and stool
  • pharmacokinetic measurements
Not Provided
Complete list of historical versions of study NCT00069862 on ClinicalTrials.gov Archive Site
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Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia
Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia

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

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Beta-Thalassemia
  • Drug: Deferitrin (GT56-252)
  • Drug: desferoxamine (DFO)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00069862
GTC-134-102
Not Provided
Not Provided
Genzyme, a Sanofi Company
Not Provided
Not Provided
Genzyme, a Sanofi Company
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP