NCT01406470

Phase 3 Study of Immune Globulin Intravenous (Human)IVIG-SN™ in Subjects With Primary Immunodeficiency

An Open-Label, Single-Arm, Historically Controlled, Prospective, Multicenter Phase III Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in Subjects With Primary Immunodeficiency

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Green Cross Corporation · Industry
• Sex: All
• Age: 2 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases.

Detailed description

This is an open-label, single-arm, historically controlled, prospective, multicenter phase III study to evaluate the safety, efficacy and pharmacokinetics of Immune Globulin Intravenous (Human) IVIG-SN™ in subjects with primary immunodeficiency diseases. Subject will be infused every 21 to 28 days according to their previous IVIG treatment schedule. Subjects treated every 28 days will receive 13 study IVIG infusions. Subject treated every 21 days will receive 17 study IVIG infusions. Duration of treatment:The total duration of treatment is 12 months.

Conditions

• Immunologic Deficiency Syndrome

Interventions

Type	Name	Description
DRUG	Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™	IVIG-SN™ 10g/200mL, dose is 300-900 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with IVIG-SN™ will be 12 months with a 3 month follow-up.

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2011-08-01
• Last updated: 2014-01-10

Locations

11 sites across 2 countries: United States, Canada