An Open Phase 3 Study of IV-Globulin SN Inj.10% to Treat Immune Thrombocytopenia

Summary

Human immunoglobulin (Ig) is the most commonly used blood product. It has been well-defined the efficacy in patients with immunodeficiencies, Kawasaki disease, asthma and other immune diseases. It is expected that Ig 10% will improve the usefulness and safety profile compared to Ig 5% because it is expected the reduced hospitalization/treatment duration and less adverse events related to volume overload.

Timeline

Start

2014-06

Primary completion

2016-04

Completion

2016-04

Outcome

Met primary endpoint

paper In intent-to-treat analysis, 61.3 patients (75.7%) achieved response and satisfied the pre-defined non-inferiority condition. PMID 29736158 ↗

Publications

• Hong J, Bang SM, Mun YC, Yhim HY, Lee J, Lim HS, Oh D; Korean GC IVIg Investigators. Efficacy and Safety of a New 10% Intravenous Immunoglobulin Product in Patients with Primary Immune Thrombocytopenia (ITP). J Korean Med Sci. 2018 Apr 24;33(19):e142. doi: 10.3346/jkms.2018.33.e142. eCollection 2018 May 7.

Drugs

Indications