Clinical Trial: 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
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A One-year, Open-label, Single Arm, Multi-center Trial Evaluating the Efficacy and Safety of Oral ICL670 (20 mg/kg/d) in Patients Three to Six Months After Allogeneic Hematopoietic Cell Transplantatio
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 must be due to blood transfusions.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: To assess iron chelation by comparing serum ferritin values at baseline vs. 52 weeks of treatment with deferasirox [ Time Frame: 52 weeks ]
Original Primary Outcome: To assess iron chelation by comparing serum ferritin values at baseline vs. 52 weeks of treatment with deferasirox
Current Secondary Outcome: To evaluate the relationship between serum ferritin, transferrin (TRF) and transferrin saturation during the whole study. [ Time Frame: 52 weeks ]
Original Secondary Outcome: To evaluate the relationship between serum ferritin, transferrin (TRF) and transferrin saturation during the whole study.
Information By: Novartis
Dates:
Date Received: April 2, 2008
Date Started: February 2008
Date Completion:
Last Updated: November 16, 2016
Last Verified: November 2016