NCT01412385

Immune Globulin Subcutaenous (Human), 20%

A Clinical Study of Immune Globulin Subcutaneous (Human) (IGSC), 20% for the Evaluation of Efficacy, Safety, and Pharmacokinetics in Subjects With Primary Immunodeficiency Diseases

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Baxalta now part of Shire · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to develop a 20% subcutaneous immunoglobulin treatment option for patients with primary immunodeficiency (PID) diseases.

Conditions

• Primary Immunodeficiency Diseases (PID)

Interventions

Type	Name	Description
BIOLOGICAL	Immune Globulin Subcutaneous (Human), 20%	Subcutaneous infusion (regulated via a pump), Epoch 2 only (all subjects)
BIOLOGICAL	Immune Globulin Intravenous (Human), 10%	Intravenous infusion (regulated via a pump)
BIOLOGICAL	Human Normal Immunoglobulin (Subcutaneous - Intramuscular Immunoglobulin)	Subcutaneous infusion (regulated via a pump)

Timeline

• Start date: 2011-06-20
• Primary completion: 2014-05-13
• Completion: 2014-05-13
• First posted: 2011-08-09
• Last updated: 2021-05-05

Locations

12 sites across 5 countries: Austria, Germany, Hungary, Sweden, United Kingdom