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

Tracking Information
First Received Date ^ICMJE	October 2, 2003
Last Updated Date	June 19, 2008
Start Date ^ICMJE	September 2003
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: August 18, 2005)	safety and tolerability iron excretion in urine and stool pharmacokinetic measurements
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00069862 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia
Official Title ^ICMJE	Iron Balance Study of DFO and GT56-252 in Patients With Transfusional Iron Overload Secondary to Beta-Thalassemia
Brief Summary	A clinical trial designed to compare the safety and iron excretion properties of desferoxamine (DFO) and deferitrin (GT56-252), an experimental oral iron chelator.
Detailed Description
Study Phase	Phase I, Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Condition ^ICMJE	Beta-Thalassemia
Intervention ^ICMJE	Drug: Deferitrin (GT56-252) Drug: desferoxamine (DFO)
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	25
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00069862
Responsible Party
Study ID Numbers ^ICMJE	GTC-134-102
Study Sponsor ^ICMJE	Genzyme
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Genzyme
Verification Date	May 2007
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP