CompletedPhase 4

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

Germany75 participantsStarted 2008-02

Plain-language 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 must be due to blood transfusions.

Who can participate

Age range18 Years

SexALL

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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.

What they're measuring

To assess iron chelation by comparing serum ferritin values at baseline vs. 52 weeks of treatment with deferasirox

Timeframe: 52 weeks

Trial details

NCT IDNCT00654589

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-01

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