Overview
Efficacy and Safety of Efficacy and Safety of Continued Iron Chelation Therapy In Poly-transfused Thalassemia Patients With Low Serum Ferritin (< 500 ng/ml)
Status:
Unknown status
Unknown status
Trial end date:
2015-11-01
2015-11-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
safety and efficacy of different iron chelation therapy in transfusion dependent beta-thalaasemia patients with low serum ferritin and continued regular transfusion regimen.Phase:
N/AAccepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Ain Shams UniversityTreatments:
Deferiprone
Deferoxamine
Criteria
Inclusion Criteria:- • Subjects with low transfusional iron overload secondary to thalassemia major showing
downward-trend in SF over last 6 months ( 2 readings are needed).
- Thalassemia major patients with SF equal or less than 500 after reduction of
chelation dose. Patients on different types of chelation monotherapy will be
included
- 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 assent or consent forms.
Exclusion Criteria:
- 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
screening.
- 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 a month afterwards who are pregnant or breast-feeding.
- An inability to adhere to the designated procedures and restrictions of this protocol.