The 301 study compared treatment with Feraheme to treatment with placebo. The study was robust, enrolling 808 at 136 sites in the United States, Canada, India, Latvia, Hungary, and Poland. The patients enrolled in this study, as I mentioned, had a history of unsatisfactory response to oral iron or could not otherwise tolerate oral iron, and therefore they never achieved the desired clinical benefit from oral iron treatment. As in IDA-302, the patients enrolled in this study had iron deficiency anemia associated with various conditions including abnormal uterine bleeding, cancer, gastrointestinal disorders or other causes.
Patients in this study were randomized 3:1 to receive a 1.0 gram intravenous course of Feraheme or placebo with 608 patients randomized through the Feraheme treatment arm and 200 patients randomized through the placebo treatment arm. This study was designed to demonstrate superiority on efficacy. The demographics and baseline parameters were found to be well balanced between the two treatment groups with a mean baseline hemoglobin level of 8.9 g/dL in the Feraheme arm and 8.8 g/dL in the placebo arm.
As in the IDA-302 Phase II study previously reported, the primary efficacy endpoints for this study differs depending upon the regulatory body. For European regulatory authorities, we are measuring the mean change in hemoglobin from baseline to week five. For the FDA, the proportion of patients who achieved a ≥2.0 g/dL increase in hemoglobin at any time from baseline to week five is the primary endpoint of this study.