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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


Phase 4
18 Years
N/A
Not Enrolling
Both
Myelodysplastic Syndrome

Thank you

Trial Information

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


Inclusion Criteria:



- 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 Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the antioxidative effect of Exjade therapy in MDS patients

Principal Investigator

Rachmilewitz Eliezer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Wolfson Medical Center

Authority:

Israel: Israeli Health Ministry Pharmaceutical Administration

Study ID:

CICL670A2412-HMO-CTIL

NCT ID:

NCT00452660

Start Date:

May 2007

Completion Date:

August 2008

Related Keywords:

  • Myelodysplastic Syndrome
  • IRON
  • oxidative stress
  • MDS
  • Myelodysplastic Syndromes
  • Preleukemia
  • Iron Overload

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