Clinical Trial: Safety and Efficacy of Desferasirox in Chinese Patients With Iron Overload and Aplastic Anemia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Single Arm, Multicenter, Open Label Study of Desferasirox in Chinese Patients With Iron Overload and Aplastic Anemia
Brief Summary: The study is designed to collect safety and efficacy of Desferasirox in Chinese patients with Iron Overload and Aplastic Anemia.
Detailed Summary:
Sponsor: Novartis Pharmaceuticals
Current Primary Outcome: Change in serum ferritin from baseline to 52 weeks with desferasirox treatment in Chinese patients with AA presenting with transfusional hemosiderosis and pre-existing serum ferritin levels of ≥ 1000 ng/mL. [ Time Frame: Every 4 Weeks for 52 weeks of treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Correlation between serum ferritin (SF) and transferrin saturation (TFS) [ Time Frame: Every 4 Weeks for 52 weeks of treatment ]Study will compare SF with TFS level to find degree of relationship measured by correlation.
- Number of dispensed, used, partially used or unused packages of study medication to assess drug usage compliance [ Time Frame: Every 4 Weeks for 52 weeks of treatment ]
- Correlation between dose adjustment (increase or decrease) regimens and transfusional burden [ Time Frame: Every 3 months for 52 Weeks of treatment ]Evaluation of the relationship between dose adjustment regimens (as dictated by both efficacy and safety parameters) and transfusional burden will be undertaken.
- Number of patients with adverse events, serious adverse events and death [ Time Frame: Every 4 weeks for 52 Weeks of treatment ]
Original Secondary Outcome: Same as current
Information By: Novartis
Dates:
Date Received: November 10, 2011
Date Started: October 2011
Date Completion:
Last Updated: October 27, 2014
Last Verified: October 2014