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 ]

Difference in serum ferritin from baseline vs. 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