Clinical Trial: Efficacy and Safety of Deferasirox in Combination With Deferoxamine Followed by Deferasirox Monotherapy in Severe Cardiac Iron Overload
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of Deferasirox in Combination With Deferoxamine Followed by Deferasirox Monotherapy in Patients With Severe Card
Brief Summary: This study will evaluate the efficacy and safety of deferasirox in combination with deferoxamine followed be deferasirox monotherapy in patients with severe iron overload due to chronic blood transfusions.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: change in cardiac iron content as measured by T2*.Cardiac T2* is the relaxation time, a cardiac magnetic resonance parameter expressed in milliseconds (ms)inversely correlated to the amount of iron in the heart. [ Time Frame: month 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percentage of patients achieving MRI-measured cardiac T2* ≥ 10 ms (but at least 10% relative increase in cardiac T2* from baseline) [ Time Frame: Months 6, 12, 18 and 24 ]
- Change in cardiac iron content reflected by change in MRI-measured cardiac T2* [ Time Frame: Months 6, 18 and 24 ]
- change in MRI-measured parameters of the left and right ventricle (left and right heart) [ Time Frame: Months 6, 12, 18 and 24 ]
- occurrence and severity of adverse events and of abnormal laboratory and special safety assessments (laboratory safety values, ECG, vital signs, auditory and ophthalmic examinations) [ Time Frame: 24 months ]
- time to achieve MRI-measured cardiac T2* ≥ 10 ms [ Time Frame: 24 months ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: September 21, 2010
Date Started: January 2011
Date Completion:
Last Updated: November 3, 2014
Last Verified: November 2014
