Clinical Trial: Efficacy and Safety of Deferasirox in Patients With Chronic Anemia and Transfusional Hemosiderosis

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

Official Title: A Multi-Center, Open-label, Non Comparative, Phase II Trial on Efficacy and Safety of ICL670 Given for 1 Year With Dose Adjustments Based on Serum Ferritin in Patients With Chronic Anemia and Transfus

Brief Summary:

The overall purpose of this trial is to further evaluate the efficacy and safety of deferasirox, dosed initially according to the transfusional iron intake, in patients with transfusion dependant anemia related to disorders other than β-thalassemia and sickle cell disease.

During the study, the dose will be adjusted based on serum Ferritin.The overall purpose of the extension is to allow further treatment of patients who have already completed the core study, and to enable collection of long term efficacy and safety data. Patients will continue to receive Deferasirox at the dose they received at the end of the core study.


Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Change of Liver iron concentration measured by R2 MRI over a period of 1 year treatment. [ Time Frame: 12 months, 24 months ]

Original Primary Outcome: Change of Liver iron concentration measured by R2 MRI over a period of 1 year treatment.

Current Secondary Outcome:

  • Change of serum ferritin concentration over a period of 1 year treatment. [ Time Frame: 12 months, 24 months ]
  • Evaluation of safety and tolerability of deferasirox in Japanese patients. [ Time Frame: 12 months, 24 months ]
  • Evaluation of Iron balance after 1 year of treatment [ Time Frame: 12 months, 24 months ]
  • Evaluation of serum ferritin as a marker for accurate monitoring of chelation therapy [ Time Frame: 12 months, 24 months ]
  • Evaluation of ophthalmologic safety of deferasirox [ Time Frame: 12 months, 24 months ]


Original Secondary Outcome: Change of serum ferritin concentration measured by R2 MRI over a period of 1 year treatment. Evaluation of safety and tolerability of deferasirox over one year

Information By: Novartis

Dates:
Date Received: February 27, 2008
Date Started: October 2007
Date Completion:
Last Updated: November 15, 2016
Last Verified: November 2016