NCT00419341

Study of Subcutaneous Immunoglobulin in Patients With PID Requiring IgG Replacement Therapy

A Phase III Open-Label, Prospective, Multicenter Study of the Efficacy, Tolerability, Safety, and Pharmacokinetics of Immune Globulin Subcutaneous (Human), IgPro20 in Subjects With Primary Immunodeficiency (PID)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 2 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the efficacy, tolerability, safety and pharmacokinetics of IgPro20 in patients with primary humoral immunodeficiency (PID).

Detailed description

The entire study consists of a 12-week wash-in/wash-out period followed by a 12-month treatment period. Pharmacokinetic (PK) parameters were assessed in a sub-group of subjects.

Conditions

• Primary Immune Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	Human Normal Immunoglobulin for Subcutaneous Administration

Timeline

• Start date: 2006-11-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-01-08
• Last updated: 2013-01-25
• Results posted: 2013-01-25

Locations

13 sites across 1 country: United States