NCT02063789

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

Prospective, Non-Randomized, Open-label, Single-arm, Multi-Center Phase III Clinical Trial to Evaluate the Efficacy and Safety of IV-Globulin SN Inj.10% in the Patients Diagnosed With Immune Thrombocytopenia (ITP).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

GC5107A (IV-Globulin SN Inj. 10%) is a polyvalent intravenous human immunoglobulin G preparation. It is prepared from plasma collected from more than 1000 healthy blood donors and it expresses the large spectrum of antibody specificity.

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Human immunoglobulin intravenous	After GC5107A Intravenous injection, evaluate platelet increase

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2014-02-14
• Last updated: 2016-05-25

Locations

14 sites across 1 country: South Korea