A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)

Summary

The main purpose of this study is to assess the efficacy and safety of LIV-GAMMA SN Inj. in adult subjects with ITP. The primary objective of this study is to determine the responder rate. A response is defined as a platelet count of ≥30×10\^9/L and at least a 2 fold increase of the baseline, confirmed on at least 2 separate occasions at least 7 days apart without bleeding. The secondary objectives are to evaluate the further efficacy assessments including duration of response, and the safety of LIV-GAMMA SN Inj.

Timeline

Start

2016-10-24

Primary completion

2018-04-03

Completion

2018-09-28

Drugs

Indications