Status:
COMPLETED
Efficacy and Safety of Oral Deferasirox (20 mg/kg/d) in Pts 3 to 6 Months After Allogeneic Hematopoietic Cell Transplantation Who Present With Iron Overload
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Iron Overload
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to investigate the effects of iron chelation using deferasirox in patients who show signs of iron overload after an allogeneic stem cell transplantation The iron overload ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Transfusional iron overload three to six months after HCT with no evidence of active inflammation
- History of at least 20 units of red blood cell transfusions or 100mL/kg of prepacked red blood cells (PRBCs).
- Patients of either gender and age ≥ 18 years.
- Female patients who have reached menarche and who are sexually active must use double-barrier contraception, oral contraceptive plus barrier contraception , or must have undergone clinically documented total hysterectomy and/or ovariectomy, or tubal ligation or be postmenopausal defined by amenorrhea for at least 12 months.
- Exclusion criteria:
- Non-transfusion related iron overload
- Active malignancy
- Known active viral hepatitis or known HIV positiveness
- Mean levels of alanine aminotransferase (ALT) \> 5x ULN
- Treatment with any iron chelator after transplantation
- Uncontrolled systemic hypertension
- Serum creatinine \> 1.5 ULN and/or serum creatinine clearance \< 60 ml/min
- History of nephrotic syndrome.
- Previous history of clinically relevant ocular or auditory toxicity related to iron chelation.
- Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent the patient from undergoing study treatment
- Pregnant or breast feeding patients.
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00654589
Start Date
February 1 2008
End Date
January 1 2012
Last Update
November 17 2016
Active Locations (1)
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1
Novartis Investigative Site
Leipzig, Germany