Ig NextGen 10% in Patients With Primary Immune Deficiency (PID)

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to assess the safety, tolerability and pharmacokinetics of Ig NextGen 10% in patients with primary immune deficiency currently being treated with Intragam P. Eligible patients will switch from 3 to 4 weekly intravenous Intragam P therapy to receive seven cycles of Ig NextGen 10% treatment administered intravenously at three- to four-weekly intervals. Patients will be monitored on the study for up to 36 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CSL Limited

Criteria

Inclusion Criteria:

• Clinical diagnosis of PID

• = or >6 month use of Intragam P at three- or four-weekly intervals

• = or >6 month history of IgG trough levels of ≥ 5 g/L

Exclusion Criteria:

• Newly diagnosed PID within six months prior to Screening

• Known selective IgA deficiency or antibodies to IgA

• Immunosuppressive treatment other than topical and/ or inhaled steroids and/ or low dose oral steroids

• Protein-losing enteropathies, or kidney diseases

• History of malignancies of lymphoid cells

• Any of the following laboratory results at Screening:

• Serum Creatinine > 1.5 times the upper normal limit (UNL)

• AST or ALT concentration > 2.5 times the UNL

• Albumin < 25 g/L