High Infusion Rate Study of Immunoglobulin Intravenous (Human) 10% (NewGam)

Summary

This was a prospective, open-label, non-controlled, non-randomized multicenter Phase III study of 2 multiple-dose intravenous NewGam regimens (every 3 weeks or every 4 weeks, continuing the patient's infusion interval in the main study NCT01012323 \[NGAM-01\]) for 3 months. The primary objective of the study was to assess the safety and tolerability of high infusion rates of NewGam.

Timeline

Start

2011-05

Primary completion

2012-09

Completion

2012-09

Drugs

Indications