A Phase IV , Multicenter ,Open Label ,Non Comparative ,Investigator Initiated Study , Evaluating the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load
- Patients with myelodysplastic syndrome with an IPSS score being Intermediate-1 or
- Patients who already received ≥20 unit (100 mL/kg) of packed red blood cells and
showing evidence of iron overload (serum ferritin >1000 µg/L).
- Patients post stem cells transplantation with disease recurrence with MDS IPSS score
low or intermediate 1.
- Patients who have given consent personally in writing
- Patients with myelodysplastic syndrome with an IPSS score being Intermediate-2 or
- Patients with serum creatinine >2.0 x ULN
- Patients with ALT(SGPT) levels > 5 x ULN
- Significant proteinuria as indicated by a urinary protein/creatinine ratio >0.5 mg/mg
in a non-first void urine sample on two assessments during the screening period.
- History of HIV positive test result. When there are any signs or symptoms indicative
of the disease even if the diagnosis is not made, additional test should be
- History of clinical or laboratory evidence of active Hepatitis B or Hepatitis C
(HBsAg in the absence of HBsAb OR HCV Ab positive with HCV RNA positive and ALT above
the normal range)
- Patients with systemic uncontrolled hypertension
- Patients with unstable cardiac disease not controlled by standard medical therapy
- Systemic disease (cardiovascular, renal, hepatic, etc.) which would prevent study
- Pregnancy or breast feeding. Female of child-bearing potential should conduct
contraception during the clinical trial.
- Patients treated with systemic investigational drug within the past 4 weeks or
topical investigational drug within the past 7 days
- Other surgical or medical condition which might significantly alter the absorption,
distribution, metabolism or excretion of study drug
- Patients being considered by the investigator potentially unreliable and/or not
cooperative with regard to the study protocol
- History of hypersensitivity to any of the study drug or excipients