Clinical Trial: Safety and Efficacy of Deferasirox in Patients With Transfusion Dependent Iron Overload - a Non-comparative Extension Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A 5-year Open Label, Non-comparative Extension to a Randomized, Open-label, Phase IIa Study to Evaluate Safety, Tolerability and the Effects on Liver Iron Concentration of Repeated Doses of 10 and 20
Brief Summary: The purpose of this study is to assess the safety and the effects on liver iron of Deferasirox when given for a long treatment period in patients with transfusion dependent iron overload.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: The Relative Change From Baseline in Liver Iron Content (LIC) After Prolonged Use of Deferasirox [ Time Frame: Baseline to 7 Years ]
Original Primary Outcome: To evaluate the long term safety and tolerability profile of ICL670A after administration of multiple doses. [ Time Frame: 5 years ]
Current Secondary Outcome: Relative Change in Serum Ferritin From Baseline to 3.5 Years [ Time Frame: Baseline to 3.5 years ]
Original Secondary Outcome:
- To evaluate the long term effect of ICL670A on hepatic iron stores measured by means of SQID and the total body iron stores. [ Time Frame: 5 years ]
- To evaluate long-term serum ferritin and other surrogate markers as potential measures for the safe dose titration for ICL670A. [ Time Frame: 5 years ]
Information By: Novartis
Dates:
Date Received: October 16, 2009
Date Started: February 2003
Date Completion:
Last Updated: July 18, 2011
Last Verified: July 2011