NCT01458171

Follow-up Study of Subcutaneous Immune Globulin in Patients Requiring IgG Replacement Therapy (Japan Study)

A Multicenter Follow-up Study of Long-term Safety, Tolerability, and Efficacy of Immune Globulin Subcutaneous (Human) IgPro20 in Subjects With Primary Immunodeficiency

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the long-term safety, tolerability, and efficacy of IgPro20 in subjects with primary immunodeficiency (PID) as a follow-up to the pivotal study ZLB06\_002CR (NCT01199705).

Conditions

• Primary Immune Deficiency Disorder

Interventions

Type	Name	Description
BIOLOGICAL	Immune globulin subcutaneous (Human)	IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06\_002CR (NCT01199705).

Timeline

• Start date: 2011-04-01
• Primary completion: 2012-02-01
• Completion: 2012-04-01
• First posted: 2011-10-24
• Last updated: 2013-04-09
• Results posted: 2013-04-09

Locations

9 sites across 1 country: Japan