A clinical trial designed to compare the safety and iron excretion properties of
desferoxamine (DFO) and deferitrin (GT56-252), an experimental oral iron chelator.
- 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
- 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.
- Serious medical condition unrelated to Beta-Thalassemia.
- Participation in a previous investigational drug study within 30 days preceding
- Patients with a known allergy to DFO that prevents chronic administration.