Clinical Trial: Expanded Access of Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Study to Provide Expanded Access of (Exjade®) Deferasirox to Patients With Congenital Disorders of Red Blood Cells and Chronic Iron Overload From Blood Transfusions Who Cannot Adequately be Tre
Brief Summary: This is an open-label, non-randomized, multi-center trial designed to provide expanded access of deferasirox to patients with congenital disorders of red blood cells and chronic iron overload from blood transfusions who cannot adequately be treated with locally approved iron chelators.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Safety Profile of Deferasirox Based Upon Drug Administration and Reporting of Serious Adverse Events [ Time Frame: Baseline to end of study (Median exposure time to drug was approximately 30 weeks; Maximum exposure was 104 weeks) ]
Original Primary Outcome:
Current Secondary Outcome: The Change in Serum Ferritin Values From Baseline Through Completion of the Study [ Time Frame: Baseline to end of study (Median exposure time to drug was approximately 30 weeks; Maximum exposure was 104 weeks) ]
Original Secondary Outcome:
Information By: Novartis
Dates:
Date Received: October 6, 2005
Date Started: October 2005
Date Completion:
Last Updated: June 3, 2011
Last Verified: June 2011