Safety, Tolerability and Efficacy of Single Dose Low Cost Minipool Intravenous Immunoglobulins in Moderately Severe Newly Diagnosed ITP

Summary

To demonstrate the efficacy of new product IVIG prepared by minipool technology as assessed by Bleeding Score and platelet count at 3 days, 1 week, 2 weeks and 4 weeks. The platelet response rate is defined as the percentage of subjects responding to treatment with an increase of platelet count from ≤ 20 x 10\^9/L to ≥ 100 x 10\^9/L and absence of bleeding (complete response) or platelet count ≥ 50 x 10\^9/L and at least 2-fold increase the base line count with absence of bleeding (partial response), within the specified time frame.

Timeline

Start

2015-08

Primary completion

2016-02

Completion

2016-02

Drugs

Indications