Efficacy results for OCTAGAM 10% from the cITP clinical study
The majority of patients with cITP met the primary efficacy endpoint of clinical response as measured by a rise in platelet count1
efficacy clinical trail
Safety assessment results support the efficacy of OCTAGAM 10%1
efficacy secondary end point
Study Design: Ready-to-use OCTAGAM 10% was investigated in a prospective phase 3 study of 116 adult patients with ITP (platelet count ≤20 x 109/L). Sixty-six patients had cITP and 49 were newly diagnosed. Patients received OCTAGAM 10% 1 g/kg/day on 2 consecutive days, and the infusion rate was adjusted according to tolerability to a maximum of 12 mg/kg/min. The primary efficacy variable was the attainment of a clinical response, defined as an increase in platelet count to ≥50 x 109/L within 6 days of dosing. Secondary efficacy variables included the time to achieve a clinical response, the maximum platelet level achieved, assessment of bleeding, and the duration of platelet response.1
*Analyzed for 54 patients who achieved a response within 7 days after the first infusion.
  1. OCTAGAM 10% [prescribing information]. Hoboken, NJ: Octapharma USA Inc.; 2018.