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

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.

Timeline

Start

2007-05

Primary completion

2008-07

Completion

2008-07

Outcome

Missed primary endpoint

paper There was no significant within-patient difference in the average trough immunoglobulin G concentration between Intragam P and Intragam 10 NF PMID 22212346 ↗

paper 8.76 g/L, 8.55 g/L respectively) (geometrical mean ratio 1.034; 95% confidence interval 0.996-1.073; P = 0.079). PMID 22212346 ↗

Publications

• Results Bleasel K, Heddle R, Hissaria P, Stirling R, Stone C, Maher D. Pharmacokinetics and safety of Intragam 10 NF, the next generation 10% liquid intravenous immunoglobulin, in patients with primary antibody deficiencies. Intern Med J. 2012 Mar;42(3):252-9. doi: 10.1111/j.1445-5994.2011.02712.x.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ig NextGen 10%	Protein / enzyme biologic	0.2 g/kg	Intravenous
Subject	Ig NextGen 10%	Protein / enzyme biologic	0.8 g/kg	Intravenous
Subject	IntragamP	Unknown	0.2 g/kg	Intravenous
Subject	IntragamP	Unknown	0.8 g/kg	Intravenous

Indications