NCT00520494

Efficacy and Safety of Vivaglobin® in Previously Untreated Patients With Primary Immunodeficiency

A Multicenter Study on the Efficacy and Safety of Vivaglobin® in Previously Untreated Patients (PUPs) With Primary Immunodeficiency (PID)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: CSL Behring · Industry
• Sex: All
• Age: 1 Year – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the efficacy and safety of Vivaglobin in previously untreated patients (PUPs) with primary immunodeficiency (PID) over a 25-week observation period. The purpose is to investigate whether PUPs will respond to subcutaneous immunoglobulin (SCIG) treatment with adequate trough levels without first receiving immunoglobulins by the intravenous route by demonstrating that 100 mg immunoglobulin G/kg body weight (IgG/kg bw) administered on 5 consecutive days (i.e. resulting in a total dose of 500 mg IgG/kg bw) results in an IgG increase to ≥ 5 g/L on Day 12 after initiation of SCIG therapy.

Conditions

• Common Variable Immunodeficiency
• Agammaglobulinemia

Interventions

Type	Name	Description
DRUG	Vivaglobin	Human normal immunoglobulin G (IgG) for subcutaneous (SC) use.

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2007-08-24
• Last updated: 2013-06-20
• Results posted: 2013-05-03

Locations

6 sites across 4 countries: Canada, Germany, Italy, Spain