Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia
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|ClinicalTrials.gov Identifier: NCT00069862|
Recruitment Status : Completed
First Posted : October 3, 2003
Last Update Posted : March 5, 2015
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|Condition or disease||Intervention/treatment||Phase|
|Beta-Thalassemia||Drug: Deferitrin (GT56-252) Drug: desferoxamine (DFO)||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|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|
- safety and tolerability
- iron excretion in urine and stool
- pharmacokinetic measurements
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|United States, New York|
|The New York Presbyterian Hospital-Weill Medical College of Cornell University|
|New York, New York, United States, 10021|
|Other Study ID Numbers:||
|First Posted:||October 3, 2003 Key Record Dates|
|Last Update Posted:||March 5, 2015|
|Last Verified:||March 2015|
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Iron Metabolism Disorders