Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia
Completed · Phase 1/Phase 2
Conditions studied: Beta-Thalassemia
In brief
A clinical trial designed to compare the safety and iron excretion properties of desferoxamine (DFO) and deferitrin (GT56-252), an experimental oral iron chelator.
Key facts
- Study ID
- NCT00069862
- Run by
- Genzyme, a Sanofi Company
- People needed
- 25
- Starts
- 2003-09-01
- Expected to finish
- 2005-11-01
- Last updated by the study team
- 2015-03-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- The New York Presbyterian Hospital-Weill Medical College of Cornell University — New York, New York, United States
Full record on ClinicalTrials.gov
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