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drugset / Trial / NCT01406470

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

NCT01406470 ↗

Phase 3 Completed 45 enrolled Green Cross Corporation Atlantic Research Group · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-09
Primary completion
2013-07
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 300 mg/kg Intravenous
Subject Immune Globulin Intravenous (Human) Protein / enzyme biologic 900 mg/kg Intravenous

Indications

immunodeficiency disease