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CompletedNCT01461018

Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immunodeficiency (Japan Study)

A Multicenter Study of Long-Term Clinical Outcomes of Immune Globulin Subcutaneous (Human) (SCIG) IgPro20 in Subjects With Primary Immunodeficiency

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

Summary

The purpose of this study is to assess the long-term efficacy, tolerability, and safety of IgPro20 in subjects with primary immunodeficiency (PID) as an extension to the preceding follow-up study ZLB07\_001CR (NCT01458171).

Conditions

Interventions

TypeNameDescription
BIOLOGICALImmune globulin subcutaneous (Human)IgPro20 is a 20% (weight per volume \[w/v\]) liquid formulation of human immunoglobulin for subcutaneous (SC) use.

Timeline

Start date
2011-10-01
Primary completion
2014-07-01
Completion
2014-07-01
First posted
2011-10-27
Last updated
2014-12-02

Locations

9 sites across 1 country: Japan

Source: ClinicalTrials.gov record NCT01461018. Inclusion in this directory is not an endorsement.

Multicenter Study of Long-Term Clinical Outcomes of Subcutaneous Immune Globulin IgPro20 in Subjects With Primary Immuno (NCT01461018) · Clinical Trials Directory