|Amira A M Adly, Asst. prof.|
1 Egypt site
6 to 18 Years
Phase 2/Phase 3
– Subjects with transfusional iron overload secondary to thalassemia major , sickle cell
disease showing up-trend in SF aged 6 Years or older, may participate after Approval
of Ethical committee giving written informed consent.
– Subjects must have a serum ferritin greater than >2500 ng/mL, a platelet count greater
than 100,000/mm3, and a serum creatinine within the normal range.
– A woman of childbearing potential must have a negative serum pregnancy test at
screening. She must use a medically acceptable form of birth control during the study
and for 1 month afterward.
– The subjects must also have a level of understanding and willingness to cooperate with
the confinement and procedures described in the consent form and scheduled by the
study site. In addition, he/she must be able to provide voluntary written informed
– Subjects with a past history of agranulocytosis, history of clinically significant
gastrointestinal, renal, hepatic ALT > 10 times high normal, OR > 50% increase of
serum creatinine from basal value, pulmonary or cardiovascular disease. Patients with
a history of tuberculosis, epilepsy, psychosis, glaucoma or any other condition, which
in the opinion of the investigators, would jeopardize the safety of the subject or
impact the validity of the study results.
– Subjects with HIV positive or have active HCV.
– A history of serious immunologic hypersensitivity to any medication, such as
anaphylaxis or angioedema.
– Participation in a previous investigational drug study within the 30 days preceding
– Women who are pregnant, or breast-feeding.
– Current alcohol or drug abuse.
– An inability to adhere to the designated procedures and restrictions of this protocol.
– Subjects receiving warfarin, digoxin, or anti-arrhythmic or anti-seizure medications.
– Subjects with a known allergy to Exjade or DFP that prevents chronic administration.