An Algorithm to Start Iron Chelation in Minimally Transfused Young Beta-thalassemia Major Patients
Status:
Unknown status
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
Summary
A prospective randomized study on Safety, Tolerability and Efficacy of oral Low dose DFP (50
mg/kg/day) in minimally transfused B-TM after 5 transfusions when SF reaches 500 ng/m and
with either appearance of LPI > 0.2 or TSAT reaches 50% compared with non treatment arm.
So the aim of this study:
1. To determine the time as well as amount of transfused iron ( calculated in mg iron/kg )
which lead to Serum ferritin reaches 500 ng /ml and LPI appearance >0.2 as well as TSAT
reaches 50 % .
2. Tolerability and safety of early low dose DFP 50mg/kg and effectiveness to postpone or
prevent SF from reaching 1000 ng/ml or LPI >0.6 or TSAT >70% in comparison to patients
not starting chelation therapy
3. Determine adverse events whether drug or non drug related