NCT00391131

Subcutaneous Ig NextGen 16% in PID Patients

A Multi-centre, Open-label Study to Assess the Efficacy, Tolerability, Safety and Pharmacokinetics of Subcutaneous Infusions of Ig NextGen 16% in Patients With Primary Immunodeficiency (PID).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: CSL Limited · Industry
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess the safety, tolerability, efficacy and pharmacokinetics of Ig NextGen 16% in people with antibody deficiency currently being treated with IntragamP. Ig NextGen 16% is a liquid immunoglobulin (antibody) preparation manufactured using predominately chromatographic techniques. Eligible patients will switch from monthly intravenous IntragamP therapy to weekly subcutaneous Ig NextGen 16% treatment. Initial hospital training will be required for subcutaneous administration and then the patient will perform the infusion in their own home, returning once a month for a supervised infusion. Patients will be monitored on the study for up to 10 months to assess blood IgG levels and rate of serious bacterial infections.

Conditions

• Primary Immunodeficiency (PID)

Interventions

Type	Name	Description
DRUG	IgNextGen 16%	IgNextGen 16% administered subcutaneously on a weekly basis from visit 1 to 12

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2006-10-23
• Last updated: 2012-06-07

Locations

12 sites across 2 countries: Australia, New Zealand