NCT00546871

Comparison of Intravenous and Subcutaneous Administration of IGIV, 10% in Primary Immunodeficiency (PID) Subjects

Tolerability and Pharmacokinetic Comparison of Immune Globulin Intravenous (Human) 10% (IGIV, 10%) Administered Intravenously or Subcutaneously in Subjects With Primary Immunodeficiency Diseases

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 24 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the tolerability of IGIV, 10% given subcutaneously and the pharmacokinetics of immunoglobulin G (IgG) following subcutaneous (SC) treatment with IGIV, 10% in subjects with primary immunodeficiency (PID) disorders.

Conditions

• Primary Immunodeficiency Diseases (PID)

Interventions

Type	Name	Description
DRUG	Immune Globulin Intravenous (Human), 10%	Intravenous administration in Study Part 1, subcutaneous administration in Study Parts 2 and 3

Timeline

• Start date: 2007-10-03
• Primary completion: 2009-07-01
• Completion: 2009-09-01
• First posted: 2007-10-19
• Last updated: 2021-05-19
• Results posted: 2012-08-23

Locations

9 sites across 1 country: United States