GTC-134-102: Iron Balance Study of DFO and GT56-252 in Patients with Transfusional Iron Overload Secondary to Beta-Thalassemia

This study has been completed.

Sponsored By:	Genzyme
Information Provided By:	Genzyme
ClinicalTrials.gov Identifier:	NCT00069862

Purpose

A clinical trial designed to compare the safety and iron excretion properties of desferoxamine (DFO) and deferitrin (GT56-252), an experimental oral iron chelator.

Condition	Intervention	Phase
beta-Thalassemia	Drug: Deferitrin (GT56-252) Drug: desferoxamine (DFO)	Phase I, Phase II

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Further Study Details:

Primary Outcomes: safety and tolerability; iron excretion in urine and stool; pharmacokinetic measurements

Expected Total Enrollment: 25

Study start: September 2003

Eligibility

Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both

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

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier NCT00069862

New York
The New York Presbyterian Hospital-Weill Medical College of Cornell University, New York, New York, 10021, United States; Recruiting

More Information

Study ID Numbers: GTC-134-102
ClinicalTrials.gov Identifier: NCT00069862
Health Authority: United States: Food and Drug Administration