Status:
COMPLETED
Evaluation the Effect of Exjade on Oxidative Stress in Low Risk Myelodysplastic Syndrome Patients With Iron Over Load
Lead Sponsor:
Wolfson Medical Center
Collaborating Sponsors:
Hadassah Medical Organization
Tel-Aviv Sourasky Medical Center
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Certain percentage of MDS patients develop iron overload. Iron is known to participate in intracellular reactions that generate free radicals, inducing oxidative stress and apoptosis, which was found ...
Eligibility Criteria
Inclusion
- Patients with myelodysplastic syndrome with an IPSS score being Intermediate-1 or low.
- 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
Exclusion
- Patients with myelodysplastic syndrome with an IPSS score being Intermediate-2 or High.
- 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 conducted.
- 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 treatment
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00452660
Start Date
May 1 2007
End Date
August 1 2008
Last Update
June 16 2014
Active Locations (1)
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1
Wolfsom Medical Center
Holon, Israel, 58100