NCT01315496

GCIV as an Adjuvant Therapy for Community-Acquired Severe Sepsis or Septic Shock

A Placebo-controlled, Randomized, Double-blind, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Administration of 'IV-Globulin S Inj.' in Adult Subjects With Community-Acquired Severe Sepsis or Septic Shock

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 214 (estimated)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to determine whether the intravenous application of 'Ⅳ-Globulin S inj. (Human Immunoglobulin G)' can reduce mortality in patients with severe sepsis or septic shock.

Detailed description

A Placebo-controlled, Randomized, Double-blind, Multi-center, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous Administration of 'IV-Globulin S inj.(Human Immunoglobulin G)' as an Adjuvant Therapy in Adult Subjects with Community-Acquired Severe Sepsis or Septic Shock.

Conditions

• Severe Sepsis
• Septic Shock

Interventions

Type	Name	Description
DRUG	Immunoglobulin G	Immunoglobulin 1.5-2g/Kg/3days

Timeline

• Start date: 2009-10-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2011-03-15
• Last updated: 2013-04-30

Locations

17 sites across 1 country: South Korea