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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

For Condition: beta-Thalassemia
Status: Recruiting
Sponsor(s): Genzyme ,
Synopsis: A clinical trial designed to compare the safety and iron excretion properties of desferoxamine (DFO) and GT56-252, an experimental oral iron chelator.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA Patients must meet all of the following 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 Patients must not meet any of the following 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.
Total Enrollment: 12

Location and Contact Information:

The New York Presbyterian Hospital-Weill Medical College of Cornell University *Recruiting*
New York City,  New York,  10021
United States
Recruiting Robert  Grady 212-746-3400


Additional Information:
Study ID Numbers:
  GTC-134-102; 
Study Start Date: September 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00069862

Other Beta-Thalassemia Studies:
1. Phase II Study of Arginine Butyrate With or Without Epoetin alfa in Patients With Thalassemia Intermedia

2. Safety & Efficacy of ICL670 vs. deferoxamine in Beta-thalassemia patients with iron overload due to blood transfusions

3. Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN)

4. Study of ICL670 in iron overload from beta-thalassemia unable to be treated with deferoxamine or chronic anemias

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

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