Clinical Trial: Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Extension Study of Iron Chelation Therapy With Deferasirox in Patients With Transfusional Iron Overload

Brief Summary:

A 1-year randomized Phase IIa core trial followed by a prolongation of 5 to 9 months was conducted to investigate the efficacy and safety of deferasirox in patients aged ≥ 18 years with transfusion-dependent iron overload.

The objective of this extension study is to assess the long-term safety of deferasirox and to provide treatment in patients with transfusional iron overload.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment [ Time Frame: at 3, 4, 5 years ]

Original Primary Outcome: Long-term safety and tolerability of ICL670, at 3, 4, and 5 years treatment

Current Secondary Outcome: Change in liver iron content measured by SQUID, at 3, 4, and 5 years [ Time Frame: at 3, 4, 5 years ]

Original Secondary Outcome: Change in liver iron content measured by SQUID, at 3, 4, and 5 years

Information By: Novartis

Dates:
Date Received: October 14, 2005
Date Started: July 2002
Date Completion:
Last Updated: March 18, 2015
Last Verified: March 2015