Subcutaneous Ig NextGen 16% in PID Patients

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.

Timeline

Start

2007-04

Primary completion

2009-10

Completion

2009-10

Outcome

Met primary endpoint

paper No SBIs were reported during the study. PMID 22526590 ↗

paper Evogam produced significantly higher mean trough IgG concentrations with 1:1 dose conversion compared to previous immunoglobulin treatment (8.94 versus 8.27 g/L, p = 0.0063). PMID 22526590 ↗

Publications

• Results Empson MB, Tang ML, Pearce LK, Rozen L, Gold MS, Katelaris CH, Langton D, Smart J, Smith WB, Steele RH, Ziegler JB, Maher D. Efficacy, safety and pharmacokinetics of a novel subcutaneous immunoglobulin, Evogam(R), in primary immunodeficiency. J Clin Immunol. 2012 Oct;32(5):897-906. doi: 10.1007/s10875-011-9641-4. Epub 2012 Apr 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Evogam	Protein / enzyme biologic	—	Subcutaneous

Indications