Connect with LRI:

Lupus Clinical Trials

New Medical Therapies™


December 19, 2011

Novartis reported results from a phase III trial of Exjade for non-transfusion-dependent thalassemia. This one-year, randomized, double-blind, placebo-controlled pivotal study, THALASSA, enrolled 166 subjects 10 years of age and older with beta-thalassemia intermedia, alpha-thalassemia or Hemoglobin E/beta-thalassemia. The subjects were randomized to Exjade doses of 5 mg/kg/day or 10 mg/kg/day or matching placebo. Exjade at a 10 mg/kg/day starting dose significantly reduced liver iron concentration (LIC) from baseline by 3.8 mg of iron per gram of liver dry weight (Fe/g dw) compared to an increase of 0.38 mg Fe/g dw for placebo (p<0.001). The 10 mg/kg/day dose was superior to a 5 mg/kg/day dose (p≡0.009). In the 10 mg/kg arm, 49% of subjects had a LIC decrease of at least 30% from baseline versus only 2% in the placebo arm. In addition, 56% of subjects in the 10 mg/kg arm had a LIC decrease of greater than or equal to 3 mg at one year compared to 11% in the placebo arm.

This information does not represent a Lupus Research Institute endorsement of any listed study. It is merely a notice that the study is available. If you are presently under the care of a physician for lupus or other conditions, you should not disrupt your current program without discussing it with your doctor(s). Do not contact the Lupus Research Institute for information on these studies. Only contact the listed numbers. The Lupus Research Institute does not have any jurisdiction over or further involvement with these studies, other than to make people aware that they are being conducted.