NCT05566990

A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj.10% in Primary Immune Thrombocytopenia (ITP)

A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj.10% in Primary Immune Thrombocytopenia (ITP)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: SK Plasma Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of LIV-GAMMA SN Inj.10% administered for 2 days in adult subjects with primary immune thrombocytopenia (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 time to response and duration of response, and the safety of LIV-GAMMA SN Inj.10%.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
BIOLOGICAL	LIV-GAMMA SN Inj.10%	LIV-GAMMA SN Inj. 10% is administered intravenously at a dose of 1 g/kg daily for 2 consecutive days to patients with primary immune thrombocytopenia.

Timeline

• Start date: 2019-07-19
• Primary completion: 2021-06-03
• Completion: 2021-11-26
• First posted: 2022-10-05
• Last updated: 2022-10-05

Locations

11 sites across 1 country: South Korea